Background: This study aimed to evaluate the predictive performance of low serum calcium and phosphorus in discriminative diagnosis of the severity of COVID-19 patients.

Methods: We conducted a single-center hospital-based study and consecutively recruited 122 suspected and 104 confirmed COVID-19 patients during January 24 to April 25, 2020. The clinical risk factors of COVID-19 were identified. The discriminative power of low calcium and phosphorus regarding the disease severity was evaluated.

Results: Low calcium and low phosphorus are more prevalent in severe/critical COVID-19 patients than moderate COVID-19 patients (OR 15.07, 95%CI 1.59 -143.18 for calcium, OR 6.90, 95%CI 2.43 – 19.64 for phosphorus). The specificity in detecting the severe/critical patients among COVID-19 patients reached 98.5% (95%CI 92.0-99.7%) and 84.4% (95%CI 74.3-91.6%) by low calcium and low phosphorus, respectively, albeit with suboptimal sensitivity. Calcium and phosphorus combined with lymphocyte count could obtain the best discriminative performance for the severe COVID-19 patients (area under the curve (AUC) = 0.80), and combined with oxygenation index was promising (AUC = 0.71). Similar discriminative performances of low calcium and low phosphorus were found between suspected and confirmed COVID-19 patients.

Conclusions: Low calcium and low phosphorus could indicate the severity of COVID-19 patients, and may be utilized as a promising clinical biomarker for discriminative diagnosis

Based on available evidence, the COVID-19 virus is thought to spread through close contact and droplet transmission. However, some have debated that it could be airborne. Airborne transmission occurs when particles of less than 0.5 μm within droplets spread through exhaled air via a process called aerosolisation. These particles can remain in the air for long periods and can disseminate over distances further than 1 meter. In the context of COVID-19, airborne particles can occur during certain aerosolised-generating-procedures (AGP). WHO underlines the use of N95 respirators or equivalent as part of personal protective equipment (PPE) for healthcare workers (HCW) managing COVID-19 positive patients when aerosolised-generating-procedures (AGP) are being conducted.This retrospective observational study describes the result of COVID-19 reverse transcriptase polymerase chain reaction (RT-PCR) in health care workers (HCW) wearing different form of personal protective equipment (PPE) who had had close contact with a confirmed COVID-19 patient during performing such procedures. All HCWs were quarantined for 14 days after the exposure. COVID-19 RT-PCR nasopharyngeal swabs were performed at different intervals. Little is known about the effectiveness of different types of personal protective equipment (PPE) for preventing SARS-CoV-2 in HCWs. We describe the clinical outcome of HCWs exposed to sudden acute respiratory infection patient before the diagnosis of COVID-19 was known

Introduction: Several randomized clinical trials (RCTs) that investigated the effectiveness of remdesivir for the treatment of Covid-19 have generated inconsistent evidence. The present study aimed to synthesize available RCT evidence using network meta-analyses (NMAs).

Methods: Both blinded and open-label RCTs in PubMed database from inception to June 7, 2020 that contained “remdesivir”, “Covid-19”, and “trial” in the abstracts conducted on hospitalized Covid-19 persons were identified and screened. The studies must have at least one remdesivir arm and evaluated one of the pre-specified outcomes. The outcomes were clinical improvement between days 10-15 after randomization and clinical recovery during the follow-up period. The identified literature was supplemented with relatively recent studies that were known to the researchers if not already included. Frequentist NMAs with random effects were conducted.

Results: Both 10-day and 5-day remdesivir regimens were associated with higher odds of clinical improvement [odds ratio (OR) of 10-day regimen: 1.35, 95% confidence interval (CI): 1.09 – 1.67); OR of 5-day regimen: 1.81, CI: 1.32 – 2.45] and higher probabilities of clinical recovery [relative risk (RR) of 10-day regimen: 1.24, CI: 1.07 – 1.43); RR of 5-day regimen: 1.47, CI: 1.16 – 1.87] compared with placebo.

Conclusions: Remdesivir may have clinical benefits among hospitalized Covid-19 persons.

March 21, 2020 was the ridgeline between the growth of the COVID-19 epidemic wave in Italy and the start of its decline. We analyzed the epidemic patterns from March 1 to June 30. There was a progressive drop of cases from March (104,710) to April (94,888), May (25,705) and June (8,110). Likewise, after a slight increase of deaths in April (14,804) compared to March (12,396), a considerable decline occurred in May (5,170) and June (1,464). Doubling times of cumulative cases grew from 2-6 days until March 20 to 2 weeks up to April 5, and thereafter no further doubling occurred until June 30. There was a striking North-South gradient of both cases and deaths. At the end of June, the 9 northern Italian regions or provinces, 5 central regions and 7 southern regions had contributed to the 81.1%, 12.4% and 6.5% of the 240,578 national cases, respectively. Lombardy, the most populous region, was by far the most heavily affected one, accounting for the 39.0% of the national cases occurring over the analyzed 4-month period. However, in relative terms, it was preceded by Aosta Valley, the least populous region, less than 1% of the population of both regions having been affected by cases of COVID-19. The curves showing the ratio of daily cumulative cases and deaths to those of the previous day tended to flatten with time by approaching the zero growth but without reaching it, which documents some persisting circulation of SARS-CoV-2 in the Italian territory

PCR of upper respiratory specimens is the diagnostic standard for severe acute respiratory syndrome coronavirus 2 infection. However, saliva sampling is an easy alternative to nasal and throat swabbing. We found similar viral loads in saliva samples and in nasal and throat swab samples from 110 patients with coronavirus disease.

In the early weeks of the COVID-19 pandemic, Zang and Yunhui discussed in the Journal of Medical Virology various treatment approaches as potential interventions against the virus including zinc (Zn).

Objective: To summarise currently reported neonatal cases of SARS-CoV-2 infection.

Methods: A search strategy was designed to retrieve all articles published from 1 December 2019 to 12 May 2020, by combining the terms ‘coronavirus’ OR ‘covid’ OR ‘SARS-CoV-2’) AND (‘neonat*’ OR ‘newborn’) in the following electronic databases: MEDLINE/Pubmed, Scopus, Web of Science, MedRxiv, the Cochrane Database of Systematic Review and the WHO COVID-19 database, with no language restrictions. Quality of studies was evaluated by using a specific tool for assessment of case reports and/or case series.

Results: Twenty-six observational studies (18 case reports and 8 case series) with 44 newborns with confirmed SARS-CoV-2 infection were included in the final analysis. Studies were mainly from China and Italy. Half of neonates had a documented contact with the infected mother and one out of three infected neonates was admitted from home. Median age at diagnosis was 5 days. One out of four neonates was asymptomatic, and the remaining showed mild symptoms typical of acute respiratory infections and/or gastrointestinal symptoms. The majority of neonates were left in spontaneous breathing (room air) and had good prognosis after a median duration of hospitalisation of 10 days.

Conclusions: Most neonates with SARS-CoV-2 infection were asymptomatic or presented mild symptoms, generally were left in spontaneous breathing and had a good prognosis after median 10 days of hospitalisation. Large epidemiological and clinical cohort studies, as well as the implementation of collaborative networks, are needed to improve the understanding of the impact of SARS-CoV-2 infection in neonates.

Objective: To review the current scientific evidence of vertical transmission related to coronavirus disease 2019 (COVID-19).

Methods: An integrative review was performed by two independent researchers, based on the literature available in the MEDLINE (via PubMed) and LILACS databases, using the descriptors “pregnancy” AND “COVID-19” AND “vertical transmission”. This search included case reports or case series published up until 17th June 2020 in English or Portuguese. After reading the articles available in their entirety, those related specifically to the potential risks of vertical transmission of COVID-19 during pregnancy were selected. We initially found a total of 57 articles; 26 were carefully screened and 15 were finally selected.

Results: Pregnancy can make women more susceptible to infections, especially by viral pathogens, given the various physiological and immunological changes that occur to maintain maternal-fetal balance. It is speculated that the fetus may be a possible target for COVID-19. Few studies (3 out of 15) in our analysis have found positive results for SARS-CoV-2 in fetal membranes, placenta, and in newborns right after birth. Additionally, no difference was noticed when comparing different modes of delivery, and seems reasonable to assume that pregnant women with stable clinical conditions can be encouraged for vaginal delivery.

Conclusion: Further studies with a great number of cases are warranted to elucidate whether the virus may be vertically transmitted to the fetus and if any maternal conditions can influence that. Our findings seem to demonstrate that vertical transmission is possible but quite unusual

Introduction: The study was implemented to provide guidance to decision-makers and clinicians by describing hospital care offered to women who gave birth with confirmed SARS-CoV-2 infection.

Materials and methods: National population-based prospective cohort study involving all women with confirmed SARS-CoV-2 infection who gave birth between February 25 and April 22, 2020 in any Italian hospital.

Results: The incidence rate of confirmed SARS-CoV-2 infection in women who gave birth was 2.1 per 1000 maternities at a national level and 6.9/1000 in the Lombardy Region. Overall one third of the women developed a pneumonia and 49.7% assumed at least one drug against SARS-CoV-2 infection. Caesarean rate was 32.9%, no mothers nor newborns died. Six percent of the infants tested positive for SARS-CoV-2 at birth.

Conclusions: Clinical features and outcomes of COVID-19 in women who gave birth are similar to those described for the general population, most women developing mild to moderate illness.

This report describes the evolution of COVID-19 in a 10 day-old-baby. The mother developed the disease immediately after childbirth and therefore a vertical transmission can be excluded. The isolation of the virus in cell culture with a cytopathic effect already visible after 48 hours, indicates that the viral load of the newborn was quite high, but not serious course of the disease was observed. This paper wants to highlight the possible role of newborns and children in the spread of the disease.

Objective: To assess the impact of separation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR)-positive mother-newborn dyads on breastfeeding outcomes.

Study design: This observational longitudinal cohort study of mothers with SARS-CoV-2 PCR-and their infants at 3 NYU Langone Health hospitals was conducted between March 25, 2020, and May 30, 2020. Mothers were surveyed by telephone regarding predelivery feeding plans, in-hospital feeding, and home feeding of their neonates. Any change prompted an additional question to determine whether this change was due to coronavirus disease-2019 (COVID-19).

Results: Of the 160 mother-newborn dyads, 103 mothers were reached by telephone, and 85 consented to participate. There was no significant difference in the predelivery feeding plan between the separated and unseparated dyads (P = .268). Higher rates of breastfeeding were observed in the unseparated dyads compared with the separated dyads both in the hospital (P < .001) and at home (P = .012). Only 2 mothers in each group reported expressed breast milk as the hospital feeding source (5.6% of unseparated vs 4.1% of separated). COVID-19 was more commonly cited as the reason for change in the separated group (49.0% vs 16.7%; P < .001). When the dyads were further stratified by symptom status into 4 groups-asymptomatic separated, asymptomatic unseparated, symptomatic separated, and symptomatic unseparated-the results remained unchanged.

Conclusions: In the setting of COVID-19, separation of mother-newborn dyads impacts breastfeeding outcomes, with lower rates of breastfeeding both during hospitalization and at home following discharge compared with unseparated mothers and infants. No evidence of vertical transmission was observed; 1 case of postnatal transmission occurred from an unmasked symptomatic mother who held her infant at birth

The novel coronavirus disease 2019 (COVID-19) pandemic has resulted in changes to perinatal and neonatal care, concentrating on minimizing risks of transmission to the newborn and health care staff while ensuring medical care is not compromised for both mother and infant. Current recommendations on infant care and feeding when mother has COVID-19 ranges from mother-infant separation and avoidance of human milk feeding, to initiation of early skin-to-skin contact and direct breastfeeding. Health care providers fearing risks of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) maternal-infant transmission may veer toward restricted breastfeeding practices. We reviewed guidelines and published literature and propose three options for infant feeding depending on various scenarios. Option A involves direct breastfeeding with the infant being cared for by the mother or caregiver. In option B, the infant is cared for by another caregiver and receives mother’s expressed milk. In the third option, the infant is not breastfed directly and does not receive mother’s expressed milk. We recommend joint decision making by parents and the health care team. This decision is also flexible as situation changes. We also provide a framework for counseling mothers on these options using a visual aid and a corresponding structured training program for health care providers. Future research questions are also proposed. We conclude that evidence and knowledge about COVID-19 and breastfeeding are still evolving. Our options can provide a quick and flexible reference guide that can be adapted to local needs. KEY POINTS: · SARS-CoV-2 is unlikely transmitted via human milk.. · A shared decision making on infant feeding is the preferred approach.. · Mothers can safely breastfeed with appropriate infection control measures

Objectives: To evaluate maternal and perinatal outcomes of pregnant women affected by SARS-COV-2.

Methods: This was a multinational retrospective cohort study including women with laboratory-confirmed SARS-COV-2 from 73 centers from 22 different countries in Europe, United States, South America, Asia and Australia from February 1, 2020 to April 30, 2020. Confirmed SARS-COV-2 infection was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite measure of maternal mortality and morbidity including admission to intensive care unit (ICU), use of mechanical ventilation, or death.

Results: 388 singleton pregnancies tested positive to SARS-COV-2 at RT-PCR nasal and pharyngeal swab were included in the study. The primary outcome was observed in 47/388 women (12.1%). 43/388 women (11.1%) were admitted to ICU, 36/388 (9.3%) required mechanical ventilation, and 3/388 women deceased (0.8%). Of the 388 women included in the study, 122 (31.4%) were still pregnant at the time of the study. Among the other 266 women, 6 had spontaneous first-trimester abortion, 3 had elective termination of pregnancy, 6 had stillbirth, and 251 delivered a live-born infant. The rate of preterm birth less than 37 weeks of gestation was 26.3% (70/266). Of the 251 live-born infants, 69/251 (27.5%) were admitted to NICU, with 5 neonatal deaths (2.0%). The overall rate of perinatal death was 4.1% (11/266). Only one infant (1/251, 0.4%) born from a mother tested positive during the third trimester, was found positive to SARS-COV-2 at RT-PCR.

Conclusions: SARS-COV-2 in pregnant women is associated with 0.8% rate of maternal mortality, but 11.1% rate of admission to ICU. The risk of vertical transmission seems to be negligible.

Background: Coronavirus disease 2019 (COVID-19) primarily affects adults and spares children, whereas very little is known about neonates. We tried to define the clinical characteristics, risk factors, laboratory, and imagining results of neonates with community-acquired COVID-19.

Methods: This prospective multicentered cohort study included 24 neonatal intensive care units around Turkey, wherein outpatient neonates with COVID-19 were registered in an online national database. Full-term and premature neonates diagnosed with COVID-19 were included in the study, whether hospitalized or followed up as ambulatory patients. Neonates without severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) via reverse transcriptase-polymerase chain reaction testing or whose mothers had been diagnosed with COVID-19 during pregnancy were excluded.

Results: Thirty-seven symptomatic neonates were included. The most frequent findings were fever, hypoxemia, and cough (49%, 41%, 27%, respectively). Oxygen administration (41%) and noninvasive ventilation (16%) were frequently required; however, mechanical ventilation (3%) was rarely needed. Median hospitalization was 11 days (1-35 days). One patient with Down syndrome and congenital cardiovascular disorders died in the study period. C-reactive protein (CRP) and prothrombin time (PT) levels were found to be higher in patients who needed supplemental oxygen (0.9 [0.1-8.6] vs. 5.8 [0.3-69.2] p = 0.002, 11.9 [10.1-17.2] vs. 15.2 [11.7-18.0] p = 0.01, respectively) or who were severe/critical (1.0 [0.01-8.6] vs. 4.5 [0.1-69.2] p = 0.01, 11.7 [10.1-13.9] vs. 15.0 [11.7-18.0] p = 0.001, respectively).

Conclusions: Symptomatic neonates with COVID-19 had high rates of respiratory support requirements. High CRP levels or a greater PT should alert the physician to more severe disease.

Objective: The objective of this study is to systematically synthesize the currently available literature on various modes of transmission (congenital, intrapartum, and postpartum), clinical features and outcomes of SARS-CoV-2 infection in neonates.

Methods: We conducted a comprehensive literature search using PubMed, EMBASE, and Web of Science until 9 June 2020. A combination of keywords and MeSH terms, such as COVID-19, coronavirus, SARS-CoV-2, 2019-nCoV, severe acute respiratory syndrome coronavirus 2, neonates, newborn, infant, pregnancy, obstetrics, vertical transmission, maternal-foetal transmission and intrauterine transmission, were used in the search strategy. We included studies reporting neonatal outcomes of SARS-CoV-2 proven pregnancies or neonatal cases diagnosed with SARS-CoV-2 infection.

Results: Eighty-six publications (45 case series and 41 case reports) were included in this review. Forty-five case series reported 1992 pregnant women, of which 1125 (56.5%) gave birth to 1141 neonates. A total of 281 (25%) neonates were preterm, and caesarean section (66%) was the preferred mode of delivery. Forty-one case reports describe 43 mother-baby dyads of which 16 were preterm, 9 were low birth weight and 27 were born by caesarean section. Overall, 58 neonates were reported with SARS-CoV-2 infection (4 had a congenital infection), of which 29 (50%) were symptomatic (23 required ICU) with respiratory symptoms being the predominant manifestation (70%). No mortality was reported in SARS-CoV-2-positive neonates.

Conclusion: The limited low-quality evidence suggests that the risk of SARS-CoV-2 infections in neonates is extremely low. Unlike children, most COVID-positive neonates were symptomatic and required intensive care. Postpartum acquisition was the commonest mode of infection in neonates, although a few cases of congenital infection have also been reported.

On 11th March 2020, the World Health Organization (WHO) declared the COVID-19 a pandemic. The Obstetrics and Neonatology disciplines needed to be revised to suit the institutional need to expand intensive care beds to care for confirmed or suspected patients with COVID-19 in the state of São Paulo, following the recommendations of the Institutional Crisis Committee. Three different actions were needed: the structuring of teams and advanced medical post to attend COVID-19-free patients and those with suspect or confirmed COVID-19; elaborating the protocols from the delivery room throughout hospitalization. Some special considerations about breastfeeding and rooming-in were needed. The third action was the drafting of a protocol to admit infants from other hospitals with confirmed COVID-19 as the unit never admitted outpatients before.

Objective: To evaluate if the pandemic mitigation effect of lockdown in Italy have been influenced by the level of penetration of COVID-19 in Italian Regions at the onset of containment (March 9, 2020).

Methods: We collected data published day by day from the first COVID-19 case until May 3, 2020, date of end of lockdown, by Italy’s Protezione Civile Department. Linear regression analyses were performed to evaluate possible correlations between the number of confirmed cases/100.000 residents as well as the number of new cases/100.000/day before lockdown with the number of deaths/100.000 residents at sixty days, in each Italian region.

Results: We found a significant positive correlation between the number of confirmed cases before lockdown and mortality up to sixty days (p < 0.001; R2 = 0.57) as well as between the incidence rate of new cases per day and mortality up to sixty days (p < 0.001; R2 = 0.73). Regression coefficients indicated about 2 deaths up to sixty days for every new patient with confirmed COVID-19 before lockdown, and 37 deaths for every new infected subject per day until the lockdown decree of March 9, 2020.

Conclusions: Every new infected subject before lockdown counted on the death toll of COVID-19 pandemic in Italy.

Background: The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19.

Methods: We did an open-label, randomised clinical trial at 57 centres in Brazil. We enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation; or use of invasive mechanical ventilation. Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides. All patients received hydroxychloroquine (400 mg twice daily for 10 days) because that was part of standard of care treatment in Brazil for patients with severe COVID-19. The primary outcome, assessed by an independent adjudication committee masked to treatment allocation, was clinical status at day 15 after randomisation, assessed by a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1·00 favouring the control group). The primary outcome was assessed in all patients in the intention-to-treat (ITT) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation (ie, modified ITT [mITT] population). Safety was assessed in all patients according to which treatment they received, regardless of original group assignment. This trial was registered at ClinicalTrials.gov, NCT04321278.

Findings: 447 patients were enrolled from March 28 to May 19, 2020. COVID-19 was confirmed in 397 patients who constituted the mITT population, of whom 214 were assigned to the azithromycin group and 183 to the control group. In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups (OR 1·36 [95% CI 0·94-1·97], p=0·11). Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.

Interpretation: In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19.

Importance: The current rapid worldwide spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection justifies the global effort to identify effective preventive strategies and optimal medical management. While data are available for adult patients with coronavirus disease 2019 (COVID-19), limited reports have analyzed pediatric patients infected with SARS-CoV-2.

Objective: To evaluate currently reported pediatric cases of SARS-CoV-2 infection.

Evidence review: An extensive search strategy was designed to retrieve all articles published from December 1, 2019, to March 3, 2020, by combining the terms coronavirus and coronavirus infection in several electronic databases (PubMed, Cochrane Library, and CINAHL), and following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Retrospective cross-sectional and case-control studies, case series and case reports, bulletins, and national reports about the pediatric SARS-CoV-2 infection were included. The risk of bias for eligible observational studies was assessed according to the Strengthening the Reporting of Observational Studies in Epidemiology reporting guideline.

Findings: A total of 815 articles were identified. Eighteen studies with 1065 participants (444 patients were younger than 10 years, and 553 were aged 10 to 19 years) with confirmed SARS-CoV-2 infection were included in the final analysis. All articles reflected research performed in China, except for 1 clinical case in Singapore. Children at any age were mostly reported to have mild respiratory symptoms, namely fever, dry cough, and fatigue, or were asymptomatic. Bronchial thickening and ground-glass opacities were the main radiologic features, and these findings were also reported in asymptomatic patients. Among the included articles, there was only 1 case of severe COVID-19 infection, which occurred in a 13-month-old infant. No deaths were reported in children aged 0 to 9 years. Available data about therapies were limited.

Conclusions and relevance: To our knowledge, this is the first systematic review that assesses and summarizes clinical features and management of children with SARS-CoV-2 infection. The rapid spread of COVID-19 across the globe and the lack of European and US data on pediatric patients require further epidemiologic and clinical studies to identify possible preventive and therapeutic strategies.

Asymptomatic and convalescent COVID-19 subjects may carry SARS-CoV-2 for months in their upper respiratory ways. Desiring to permanently clean the mucosal surfaces we investigated chemical agents fit to rapidly degrade the virus. Among these, hydrogen peroxide, initially tested by two of us for tolerability, showed both good performance and acceptable side effects (burning sensation for 15 – 20 seconds). We contacted circles of family physicians and the ATS Milano (Territorial Assistance and Prevention Service) and we tested this procedure on eight persistent carriers of SARS-CoV-2, performing swabs before the procedure and after it until reappearance of the virus or until 14 days (the incubation period), keeping the surfaces clean with hypertonic solution. Our patients had a median time from exposure or symptom onset of 111 days and three had relapsed after being declared ‘cured’ (two consecutive negative swabs after quarantine). One patient had a baseline negative swab and was excluded, two successfully ended the 14 days’ course, four suppressed viral elimination for 72 hours and one for 48 hours, all rebounding to weak positive (cycle thresholds above 24). Although temporarily effective, such measure may have some place in the control of viral shedding, in order to protect the most fragile subjects. This article is protected by copyright. All rights reserved.

Background: COVID-19 reinfections could be a major aggravating factor in this current pandemic, as this would further complicate potential vaccine development and help to maintain worldwide virus pockets. To investigate this critical question, we conducted a clinical meta-analysis including all available currently reported cases of potential COVID-19 reinfections.

Methods: We searched for all peer-reviewed articles in the search engine of the National Center for Biotechnology Information. While there are over 30.000 publications on COVID-19, only about 15 specifically target the subject of COVID-19 reinfections. Available patient data in these reports was analyzed for age, gender, time of reported relapse after initial infection and persistent COVID-19 positive PCR results.

Results: Following the first episode of infection, cases of clinical relapse are reported at 34 (mean) ± 10,5 days after full recovery. Patients with clinical relapse have persisting positive COVID-19 PCR testing results until 39 ± 9 days following initial positive testing. For patients without clinical relapse, positive testing was reported up to 54 ± 24 days. There were no reports of any clinical reinfections after a 70-day period following initial infection.

Conclusions: Reports of COVID-19 reinfections all appear within a vulnerable timeframe, where affected patients are still tested positive for COVID-19 via PCR. According to our data, it is most likely that all reported cases of COVID-19 reinfections are in fact protracted initial infections. To diagnose a true COVID-19 reinfection, positive COVID-19 testing combined with recurrent clinical symptoms occurring outside of this timeframe is required. This article is protected by copyright.

Purpose: Information regarding the use of lung ultrasound (LUS) in patients with Coronavirus disease 2019 (COVID-19) is quickly accumulating, but its use for risk stratification and outcome prediction has yet to be described. We performed the first systematic and comprehensive LUS evaluation of consecutive patients hospitalized with COVID-19 infection, in order to describe LUS findings and their association with clinical course and outcome.

Methods: Between 21/03/2020 and 04/05/2020, 120 consecutive patients admitted to the Tel Aviv Medical Center due to COVID-19, underwent complete LUS within 24 h of admission. A second exam was performed in case of clinical deterioration. LUS score of 0 (best)-36 (worst) was assigned to each patient. LUS findings were compared with clinical data.

Results: The median baseline total LUS score was 15, IQR [7-20]. Baseline LUS score was 0-18 in 80 (67%) patients, and 19-36 in 40 (33%) patients. The majority had patchy pleural thickening (n = 100; 83%), or patchy subpleural consolidations (n = 93; 78%) in at least one zone. The prevalence of pleural thickening, subpleural consolidations and the total LUS score were all correlated with severity of illness on admission. Clinical deterioration was associated with increased follow-up LUS scores (p = 0.0009), mostly due to loss of aeration in anterior lung segments. The optimal cutoff point for LUS score was 18 (sensitivity = 62%, specificity = 74%). Both mortality and need for invasive mechanical ventilation were increased with baseline LUS score > 18 compared to baseline LUS score 0-18. Unadjusted hazard ratio of death for LUS score was 1.08 per point [1.02-1.16], p = 0.008; Unadjusted hazard ratio of the composite endpoint (death or need for invasive mechanical ventilation) for LUS score was 1.12 per point [1.05-1.2], p = 0.0008.

Conclusion: Hospitalized patients with COVID-19, at all clinical grades, present with pathological LUS findings. Baseline LUS score strongly correlates with the eventual need for invasive mechanical ventilation and is a strong predictor of mortality. Routine use of LUS may guide patients’ management strategies, as well as resource allocation in case of surge capacity.

Background: Current mitigation strategies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rely on population-wide adoption of non-pharmaceutical interventions (NPIs). Monitoring NPI adoption and their association with SARS-CoV-2 infection history can provide key information for public health.

Methods: We sampled 1,030 individuals in Maryland from June 17 – June 28, 2020 to capture socio-demographically and geographically resolved information about NPI adoption, access to SARS-CoV-2 testing, and examine associations with self-reported SARS-CoV-2 positivity.

Results: Overall, 92% reported traveling for essential services and 66% visited friends/family. Use of public transport was reported by 18%. In total, 68% reported strict social distancing indoors and 53% strict masking indoors; indoor social distancing was significantly associated with age, and race/ethnicity and income with masking. Overall, 55 participants (5.3%) self-reported ever testing positive for SARS-CoV-2 with strong dose-response relationships between several forms of movement frequency and SARS-CoV-2 positivity. In multivariable analysis, history of SARS-CoV-2 infection was negatively associated with strict social distancing (adjusted Odd Ratio for outdoor social distancing [aOR]: 0.10; 95% Confidence Interval: 0.03 – 0.33); only public transport use (aOR for ≥7 times vs. never: 4.29) and visiting a place of worship (aOR for ≥3 times vs. never: 16.0) remained significantly associated with SARS-CoV-2 infection after adjusting for strict social distancing and demographics.

Conclusions: These results support public health messaging that strict social distancing during most activities can reduce SARS-CoV-2 transmission. Additional considerations are needed for indoor activities with large numbers of persons (places of worship and public transportation) where even NPIs may not be possible or sufficient.

We are living through a global crisis and public health practitioners have called for regulations that will limit the spread of the virus that causes COVID-19. As entire populations try to reduce the risk of viral transmission, concerns have been expressed about how to protect vulnerable populations. These include pregnant and postpartum women, newborn infants, and the healthcare workers who care for them.

Objective: The perinatal consequences of neonates born to severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) infected mothers are uncertain. This study aimed to compare the differences in clinical manifestation, laboratory results, and outcomes of neonates born to mothers with or without coronavirus disease 2019 (COVID-19).

Study design: A total of 48 neonates were admitted to Tongji Hospital and HuangShi Maternal and Child Healthcare Hospital from January 17 to March 4, 2020. The neonates were divided into three groups according to the mothers’ conditions: neonates born to mothers with confirmed COVID-19, neonates born to mothers with clinically diagnosed COVID-19, and neonates born to mothers without COVID-19. The clinical data of mothers and infants in the three groups were collected, compared, and analyzed.

Results: The deliveries occurred in a negative pressure isolation room, and the neonates were separated from their mothers immediately after birth for further observation and treatment. None of the neonates showed any signs of fever, cough, dyspnea, or diarrhea. SARS-CoV-2 reverse transcriptase-polymerase chain reaction of the throat swab and feces samples from the neonates in all three groups was negative. No differences were detected in the whole blood cell, lymphocytes, platelet, and liver and renal function among the three groups. All mothers and their infants showed satisfactory outcomes, including a 28-week preterm infant.

Conclusion: The clinical manifestations, radiological, and biochemical results did not show any difference between the three groups. No evidence of vertical transmission was found in this study whether the pregnant women developed coronavirus infection in the third (14 cases) or second trimester (1 case).

Objective: We aimed at reviewing the currently available guidelines and scientific recommendations regarding the neonatal in-hospital management and feeding in the light of the coronavirus disease 2019 (COVID-19) pandemic.

Study design: We systematically searched the guideline databases, Medline, Embase, and nationale/international neonatal societies websites as of June 19, 2020, for guidelines on neonatal management and feeding during the COVID-19 pandemic, at the same time assessing the methodological quality using the Appraisal of Guidelines for Research and Evaluation II tool.

Results: Eleven guidelines were included. The Chinese and American recommendations suggest separation of the mother and her neonate, whereas in French, Italian, UK, Canadian, and World Health Organization consensus documents the rooming-in is suggested, with Centers for Disease Control and Prevention guidelines suggesting to decide on a case-by-case basis. All the guidelines recommend breastfeeding or feeding with expressed maternal milk; the only exception is the Chinese recommendations, these last suggesting to avoid breastfeeding.

Conclusion: This review may provide a useful tool for clinicians and organizers, highlighting differences and similarities of the existing guidelines on the management and feeding strategies in the light of the COVID-19 pandemic.

Background The pandemic caused by the new coronavirus SARS-CoV-2 (Covid-19) is quite a challenging experience for the world. At the moment of birth, the fetus is prepared to face the challenge of labor and the exposure to the outside world, meaning that labor and birth represent the first extrauterine major exposure to a complex microbiota. The vagina, which is a canal for reproduction, is by evolution separated (but not far) from the anus and urethra. Passing through the birthing canal is a mechanism for intergenerational transmission of vaginal and gut microorganisms for the vertical transmission of microbiota not only from our mothers and grandmothers but also from earlier ancestors. Methods Many national and international instructions have been developed since the beginning of the Covid-19 outbreak in January 2020 in Wuhan in China. All of them pointed out hygiene measures, social distancing and avoidance of social contacts as the most important epidemiological preventive measures. Pregnancy and neonatal periods are considered as high risk for Covid-19 infection. Results The instructions defined the care for pregnant women in the delivery room, during a hospital stay and after discharge. The controversial procedures in the care of Covid-19-suspected or -positive asymptomatic women in labor were: mode of delivery, companion during birth and labor, skin-to-skin contact, breastfeeding, and visits during a hospital stay. Conclusion There is a hope that instruction on coping with the coronavirus (Covid-19) infection in pregnancy with all proposed interventions affecting mothers, babies and families, besides saving lives, are beneficial and efficient by exerting no harm.

Objective: The novel virus known as severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) has led to a terrifying pandemic. The range of illness severity among children is variable. This study aims to assess the characteristics of newborns born to SARS-CoV-2-positive women compared with those mothers who tested negative.

Study design: This was a retrospective cohort study performed at Brookdale Hospital Medical Center in New York City from March to May 2020. Electronic medical records of mother-baby dyads were reviewed.

Results: Seventy-nine mothers tested for SARS-CoV-2 were included, out of which 18.98% of mothers tested SARS-CoV-2 positive. We found a significant association between symptoms and SARS-CoV-2 status. We observed a significant association between newborns of SARS-CoV-2 positive and SARS-CoV-2 negative mothers regarding skin-to-skin contact (p < 0.001). Both groups showed significant differences regarding isolation (p < 0.001). Interestingly, regarding SARS-CoV-2 infection in newborns, only one newborn tested SARS-CoV-2 positive and was unstable in the neonatal intensive care unit (NICU). With the multivariable logistic regression model, babies of SARS-CoV-2 positive mothers were three times as likely to have desaturations in comparison to newborns from negative mothers. Also, newborns of SARS-CoV-2-positive mothers were four times more likely to have poor feeding, compared with newborns of SARS-CoV-2-negative mothers. Finally, babies of SARS-CoV-2-positive mothers were ten times more likely to be symptomatic at the 2-week follow-up.

Conclusion: SARS-CoV-2 has caused major morbidity and mortality worldwide. Neonates born to mothers with confirmed or suspected SARS-CoV-2 are most of the time asymptomatic. However, neonatal critical illness due to SARS-CoV-2 is still a possibility; thus, isolation precautions (such as avoiding skin-to-skin contact and direct breastfeeding) and vertical transmission should be studied thoroughly. In addition, testing these newborns by nasopharyngeal swab at least at 24 hours after birth and monitoring them for the development of symptoms for 14 days after birth is needed.

Although COVID-19 in pregnant women and their neonates has been demonstrated, there is not enough evidence about how this vertical transmission occurs. This report describes SARS-CoV-2 infection in a 21-year-old mother-son duo at the time of birth, focusing on the viral RNA detection in the stool of both, and the human breast milk.

Objectives: To determine the relationship between the emergence of COVID-19 and neonatal intensive care unit (NICU) family presence as well as how NICU design affects these changes.

Study design: A cross-sectional survey from April 21 to 30, 2020. We queried sites regarding NICU demographics, NICU restrictions on parental presence, and changes in ancillary staff availability.

Results: Globally, 277 facilities responded to the survey. NICU policies preserving 24/7 parental presence decreased (83-53%, p < 0.001) and of preserving full parental participation in rounds fell (71-32%, p < 0.001). Single-family room design NICUs best preserved 24/7 parental presence after the emergence of COVID-19 (single-family room 65%, hybrid-design 57%, open bay design 45%, p = 0.018). In all, 120 (43%) NICUs reported reductions in therapy services, lactation medicine, and/or social work support.

Conclusions: Hospital restrictions have significantly limited parental presence for NICU admitted infants, although single-family room design may attenuate this effect.

The pandemic of coronavirus disease 2019 (COVID-19) is caused by infection with a novel coronavirus strain, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). At present, there is limited information on potential transmission of the infection from mother to child, particularly through breast milk and breastfeeding. Here, we provide a living systematic review to capture information that might necessitate changes in the guidance on breast milk and breastfeeding given the uncertainty in this area. Our search retrieved 19,414 total records; 605 were considered for full-text eligibility and no ongoing trials were identified. Our review includes 340 records, 37 with breast milk samples and 303 without. The 37 articles with analyzed breast milk samples reported on 77 mothers who were breastfeeding their children; among them, 19 of 77 children were confirmed COVID-19 cases based on RT-PCR assays, including 14 neonates and five older infants. Nine of the 68 analyzed breast milk samples from mothers with COVID-19 were positive for SARS-CoV-2 RNA; of the exposed infants, four were positive and two were negative for COVID-19. Currently, there is no evidence of SARS-CoV-2 transmission through breast milk. Studies are needed with longer follow-up periods that collect data on infant feeding practices and on viral presence in breast milk.

Objective: To determine the clinical manifestations, risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed coronavirus disease 2019 (covid-19).

Design: Living systematic review and meta-analysis.

Data sources: Medline, Embase, Cochrane database, WHO COVID-19 database, China National Knowledge Infrastructure (CNKI), and Wanfang databases from 1 December 2019 to 26 June 2020, along with preprint servers, social media, and reference lists.

Study selection: Cohort studies reporting the rates, clinical manifestations (symptoms, laboratory and radiological findings), risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed covid-19.

Data extraction: At least two researchers independently extracted the data and assessed study quality. Random effects meta-analysis was performed, with estimates pooled as odds ratios and proportions with 95% confidence intervals. All analyses will be updated regularly.

Results: 77 studies were included. Overall, 10% (95% confidence interval 7% to14%; 28 studies, 11 432 women) of pregnant and recently pregnant women attending or admitted to hospital for any reason were diagnosed as having suspected or confirmed covid-19. The most common clinical manifestations of covid-19 in pregnancy were fever (40%) and cough (39%). Compared with non-pregnant women of reproductive age, pregnant and recently pregnant women with covid-19 were less likely to report symptoms of fever (odds ratio 0.43, 95% confidence interval 0.22 to 0.85; I2=74%; 5 studies; 80 521 women) and myalgia (0.48, 0.45 to 0.51; I2=0%; 3 studies; 80 409 women) and were more likely to need admission to an intensive care unit (1.62, 1.33 to 1.96; I2=0%) and invasive ventilation (1.88, 1.36 to 2.60; I2=0%; 4 studies, 91 606 women). 73 pregnant women (0.1%, 26 studies, 11 580 women) with confirmed covid-19 died from any cause. Increased maternal age (1.78, 1.25 to 2.55; I2=9%; 4 studies; 1058 women), high body mass index (2.38, 1.67 to 3.39; I2=0%; 3 studies; 877 women), chronic hypertension (2.0, 1.14 to 3.48; I2=0%; 2 studies; 858 women), and pre-existing diabetes (2.51, 1.31 to 4.80; I2=12%; 2 studies; 858 women) were associated with severe covid-19 in pregnancy. Pre-existing maternal comorbidity was a risk factor for admission to an intensive care unit (4.21, 1.06 to 16.72; I2=0%; 2 studies; 320 women) and invasive ventilation (4.48, 1.40 to 14.37; I2=0%; 2 studies; 313 women). Spontaneous preterm birth rate was 6% (95% confidence interval 3% to 9%; I2=55%; 10 studies; 870 women) in women with covid-19. The odds of any preterm birth (3.01, 95% confidence interval 1.16 to 7.85; I2=1%; 2 studies; 339 women) was high in pregnant women with covid-19 compared with those without the disease. A quarter of all neonates born to mothers with covid-19 were admitted to the neonatal unit (25%) and were at increased risk of admission (odds ratio 3.13, 95% confidence interval 2.05 to 4.78, I2=not estimable; 1 study, 1121 neonates) than those born to mothers without covid-19.

Conclusion: Pregnant and recently pregnant women are less likely to manifest covid-19 related symptoms of fever and myalgia than non-pregnant women of reproductive age and are potentially more likely to need intensive care treatment for covid-19. Pre-existing comorbidities, high maternal age, and high body mass index seem to be risk factors for severe covid-19. Preterm birth rates are high in pregnant women with covid-19 than in pregnant women without the disease.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited.

Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19.

Design, setting, and participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020.

Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108).

Main outcomes and measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%).

Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively.

Conclusions and relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions.

Objective: To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS.

Design, setting, and participants: Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients.

Interventions: Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148).

Main outcomes and measures: The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days.

Results: A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events.

Conclusions and relevance: Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days.

Background: There is uncertainty about the associations of angiotensive enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) drugs with COVID-19 disease. We studied whether patients prescribed these drugs had altered risks of contracting severe COVID-19 disease and receiving associated intensive care unit (ICU) admission.

Methods: This was a prospective cohort study using routinely collected data from 1205 general practices in England with 8.28 million participants aged 20-99 years. We used Cox proportional hazards models to derive adjusted HRs for exposure to ACE inhibitor and ARB drugs adjusted for sociodemographic factors, concurrent medications and geographical region. The primary outcomes were: (a) COVID-19 RT-PCR diagnosed disease and (b) COVID-19 disease resulting in ICU care.

Findings: Of 19 486 patients who had COVID-19 disease, 1286 received ICU care. ACE inhibitors were associated with a significantly reduced risk of COVID-19 disease (adjusted HR 0.71, 95% CI 0.67 to 0.74) but no increased risk of ICU care (adjusted HR 0.89, 95% CI 0.75 to 1.06) after adjusting for a wide range of confounders. Adjusted HRs for ARBs were 0.63 (95% CI 0.59 to 0.67) for COVID-19 disease and 1.02 (95% CI 0.83 to 1.25) for ICU care.There were significant interactions between ethnicity and ACE inhibitors and ARBs for COVID-19 disease. The risk of COVID-19 disease associated with ACE inhibitors was higher in Caribbean (adjusted HR 1.05, 95% CI 0.87 to 1.28) and Black African (adjusted HR 1.31, 95% CI 1.08 to 1.59) groups than the white group (adjusted HR 0.66, 95% CI 0.63 to 0.70). A higher risk of COVID-19 with ARBs was seen for Black African (adjusted HR 1.24, 95% CI 0.99 to 1.58) than the white (adjusted HR 0.56, 95% CI 0.52 to 0.62) group.

Interpretation: ACE inhibitors and ARBs are associated with reduced risks of COVID-19 disease after adjusting for a wide range of variables. Neither ACE inhibitors nor ARBs are associated with significantly increased risks of receiving ICU care. Variations between different ethnic groups raise the possibility of ethnic-specific effects of ACE inhibitors/ARBs on COVID-19 disease susceptibility and severity which deserves further study.

Importance: Coronavirus disease 2019 (COVID-19) is associated with severe lung damage. Corticosteroids are a possible therapeutic option.

Objective: To determine the effect of hydrocortisone on treatment failure on day 21 in critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory failure.

Design, setting, and participants: Multicenter randomized double-blind sequential trial conducted in France, with interim analyses planned every 50 patients. Patients admitted to the intensive care unit (ICU) for COVID-19-related acute respiratory failure were enrolled from March 7 to June 1, 2020, with last follow-up on June 29, 2020. The study intended to enroll 290 patients but was stopped early following the recommendation of the data and safety monitoring board.

Interventions: Patients were randomized to receive low-dose hydrocortisone (n = 76) or placebo (n = 73).

Main outcomes and measures: The primary outcome, treatment failure on day 21, was defined as death or persistent dependency on mechanical ventilation or high-flow oxygen therapy. Prespecified secondary outcomes included the need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (until day 21) of prone position sessions, extracorporeal membrane oxygenation, and inhaled nitric oxide; Pao2:Fio2 ratio measured daily from day 1 to day 7, then on days 14 and 21; and the proportion of patients with secondary infections during their ICU stay.

Results: The study was stopped after 149 patients (mean age, 62.2 years; 30.2% women; 81.2% mechanically ventilated) were enrolled. One hundred forty-eight patients (99.3%) completed the study, and there were 69 treatment failure events, including 11 deaths in the hydrocortisone group and 20 deaths in the placebo group. The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, -8.6% [95.48% CI, -24.9% to 7.7%]; P = .29). Of the 4 prespecified secondary outcomes, none showed a significant difference. No serious adverse events were related to the study treatment.

Conclusions and relevance: In this study of critically ill patients with COVID-19 and acute respiratory failure, low-dose hydrocortisone, compared with placebo, did not significantly reduce treatment failure (defined as death orpersistent respiratory support) at day 21. However, the study was stopped early and likely was underpowered to find a statistically and clinically important difference in the primary outcome.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes COVID-19 and is spread person-to-person through close contact. We aimed to investigate the effects of physical distance, face masks, and eye protection on virus transmission in health-care and non-health-care (eg, community) settings.

Methods: We did a systematic review and meta-analysis to investigate the optimum distance for avoiding person-to-person virus transmission and to assess the use of face masks and eye protection to prevent transmission of viruses. We obtained data for SARS-CoV-2 and the betacoronaviruses that cause severe acute respiratory syndrome, and Middle East respiratory syndrome from 21 standard WHO-specific and COVID-19-specific sources. We searched these data sources from database inception to May 3, 2020, with no restriction by language, for comparative studies and for contextual factors of acceptability, feasibility, resource use, and equity. We screened records, extracted data, and assessed risk of bias in duplicate. We did frequentist and Bayesian meta-analyses and random-effects meta-regressions. We rated the certainty of evidence according to Cochrane methods and the GRADE approach. This study is registered with PROSPERO, CRD42020177047.

Findings: Our search identified 172 observational studies across 16 countries and six continents, with no randomised controlled trials and 44 relevant comparative studies in health-care and non-health-care settings (n=25 697 patients). Transmission of viruses was lower with physical distancing of 1 m or more, compared with a distance of less than 1 m (n=10 736, pooled adjusted odds ratio [aOR] 0·18, 95% CI 0·09 to 0·38; risk difference [RD] -10·2%, 95% CI -11·5 to -7·5; moderate certainty); protection was increased as distance was lengthened (change in relative risk [RR] 2·02 per m; pinteraction=0·041; moderate certainty). Face mask use could result in a large reduction in risk of infection (n=2647; aOR 0·15, 95% CI 0·07 to 0·34, RD -14·3%, -15·9 to -10·7; low certainty), with stronger associations with N95 or similar respirators compared with disposable surgical masks or similar (eg, reusable 12-16-layer cotton masks; pinteraction=0·090; posterior probability >95%, low certainty). Eye protection also was associated with less infection (n=3713; aOR 0·22, 95% CI 0·12 to 0·39, RD -10·6%, 95% CI -12·5 to -7·7; low certainty). Unadjusted studies and subgroup and sensitivity analyses showed similar findings.

Interpretation: The findings of this systematic review and meta-analysis support physical distancing of 1 m or more and provide quantitative estimates for models and contact tracing to inform policy. Optimum use of face masks, respirators, and eye protection in public and health-care settings should be informed by these findings and contextual factors. Robust randomised trials are needed to better inform the evidence for these interventions, but this systematic appraisal of currently best available evidence might inform interim guidance.

Importance: A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.

Objective: To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.

Interventions: In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant-only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).

Design, setting, and participants: Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years. Study enrollment began on April 12, 2020. The interim analysis was conducted on June 16, 2020, and updated on July 27, 2020.

Main outcomes and measures: The primary safety outcome was the combined adverse reactions 7 days after each injection, and the primary immunogenicity outcome was neutralizing antibody response 14 days after the whole-course vaccination, which was measured by a 50% plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Results: Among 320 patients who were randomized (mean age, 42.8 years; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups.

Conclusions and relevance: In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.

Aim: The aim of the study was to evaluate the safety and efficacy profile of low-dose tocilizumab (TCZ) administered subcutaneously to patients with moderate COVID-19 pneumonia and hyperinflammation to prevent disease progression.

Methods: We retrospectively analyzed clinical characteristics and outcomes of patients with laboratory-confirmed bilateral COVID-19 pneumonia, hyperinflammation (C reactive protein ≥20 mg/dl), no hypoxemia (oxygen saturation >90%) and no contra-indications to TCZ, who were treated with subcutaneous TCZ (324 mg) administered within 48 hours from hospitalization on top of standard of care (SOC), and compared them with matched controls treated with SOC only before TCZ was available at our center. Clinical data were available for all patients until death or, for those discharged from hospital, until day 35.

Findings: Ten consecutive patients (6 males, median age 55 years) treated with TCZ on top of SOC, and ten patients (6 males, median age 56 years) treated with SOC only were included. TCZ was well-tolerated, with no clinically relevant adverse events. TCZ was associated with a reduction in CRP at day 1 (-50%, IQR -28 to -80) and day 3 (-89%, IQR -79 to -96; P = 0.005 for within-group), whereas there was no significant change in CRP values in the SOC group (P < 0.001 for between-groups comparisons at both time points). TCZ resulted in a parallel improvement of oxygenation, as assessed by the ratio of partial pressure of oxygen to fraction of inspired oxygen (P/F) ratio, which increased at day 1 (+11%, IQR + 6 to +16; P = 0.005 for within-group, and P = 0.006 for between-groups comparisons), and day 3 (+23%, IQR + 16 to +34; P = 0.005 for within-group, and P = 0.003 for between-groups comparisons). None of the TCZ-treated patients had disease progression defined as requirement of oxygen therapy or mechanical ventilation, whereas progression occurred in 5 (50%) patients among the SOC group.

Conclusions: Low-dose subcutaneous TCZ may be a safe and promising therapeutic option administered on top of SOC to prevent disease progression in hospitalized patients with moderate COVID-19 and hyperinflammation.

Background: COVID-19 has become a pandemic, but its reported characteristics and outcomes vary greatly amongst studies.

Objectives: We determined pooled estimates for clinical characteristics and outcomes in COVID-19 patients including subgroups by disease severity (based on WHO Interim Guidance Report or IDSA/ATS criteria) and by country/region.

Methods: We searched Pubmed, Embase, Scopus, Cochrane, Chinese Medical Journal, and preprint databases from January 1, 2020 to April 6, 2020. Studies of laboratory confirmed COVID-19 patients with relevant data were included. Two reviewers independently performed study selection and data extraction.

Results: From 6,007 articles, 212 studies from 11 countries/regions involving 281,461 individuals were analyzed. Overall, mean age was 46.7 years, 51.8% were male, 22.9% had severe disease, and mortality was 5.6%. Underlying immunosuppression, diabetes, and malignancy were most strongly associated with severe COVID-19 (coefficient=53.9, 23.4, 23.4, respectively, all p<0.0007), while older age, male gender, diabetes, and hypertension were also associated with higher mortality (coefficient=0.05 per year, 5.1, 8.2, 6.99, respectively, p=0.006 to 0.0002). Gastrointestinal (nausea, vomiting, abdominal pain) and respiratory symptoms (shortness of breath, chest pain) were associated with severe COVID-19, while pneumonia and end organ failure were associated with mortality.

Conclusion: COVID-19 is associated with a severe disease course in about 23% and mortality in about 6% of infected persons. Individuals with comorbidities and clinical features associated with severity should be monitored closely, and preventive efforts should especially target those with diabetes, malignancy and immunosuppression.

Background: Steroid use for COVID-19 is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by SARS-CoV-2. This study aimed at evaluating at evaluating the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19.

Methods: Parallel, double-blind, placebo-controlled, randomized, phase IIb clinical trial was performed with hospitalized patients aged ≥ 18 years with clinical, epidemiological and/or radiological suspected COVID-19, at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution), twice daily, for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. ClinicalTrials Identifier NCT04343729.

Findings: From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals. SARS-CoV-2 infection was confirmed by RT-PCR in 81.3%. Mortality at day 28 was not different between groups. A subgroup analysis showed that patients over 60 years in the MP group had a lower mortality rate at day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7.

Conclusion: The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population.

Here we present results from a survey on anti-SARS-CoV-2 seroprevalence in healthy blood donors from a low incidence COVID-19 area (Apulia region, South Eastern Italy). Among 904 subjects tested, only in 9 cases (0.99%) antibodies against SARS-CoV-2 were demonstrated. All the 9 seropositive patients were negative for the research of viral RNA by RT-PCR in nasopharyngeal swabs. These data, along with those recently reported from other countries, clearly show that we are very far from herd immunity and that the containment measures are at the moment the only realistic instrument we have to slow the spread of the pandemic.

Purpose: Coronavirus disease 2019 (COVID-19) is creating an unprecedented healthcare crisis. Understanding the determinants of mortality is crucial to optimise intensive care unit (ICU) resource use and to identify targets for improving survival.

Methods: In a multicentre retrospective study, we included 379 COVID-19 patients admitted to four ICUs between 20 February and 24 April 2020 and categorised according to time from disease onset to ICU admission. A Cox proportional-hazards model identified factors associated with 28-day mortality.

Results: Median age was 66 years (53-68) and 292 (77%) were men. The main comorbidities included obesity and overweight (67%), hypertension (49.6%) and diabetes (30.1%). Median time from disease onset (i.e., viral symptoms) to ICU admission was 8 (6-11) days (missing for three); 161 (42.5%) patients were admitted within a week of disease onset, 173 (45.6%) between 8 and 14 days, and 42 (11.1%) > 14 days after disease onset; day 28 mortality was 26.4% (22-31) and decreased as time from disease onset to ICU admission increased, from 37 to 21% and 12%, respectively. Patients admitted within the first week had higher SOFA scores, more often had thrombocytopenia or acute kidney injury, had more limited radiographic involvement, and had significantly higher blood IL-6 levels. Age, COPD, immunocompromised status, time from disease onset, troponin concentration, and acute kidney injury were independently associated with mortality.

Conclusion: The excess mortality in patients admitted within a week of disease onset reflected greater non-respiratory severity. Therapeutic interventions against SARS-CoV-2 might impact different clinical endpoints according to time since disease onset.

Objective: As coronavirus disease 2019 (COVID-19) crashed into the influenza season, clinical characteristics of both infectious diseases were compared to make a difference.

Methods: We reported 211 COVID-19 patients and 115 influenza patients as two separate cohorts at different locations. Demographic data, medical history, laboratory findings, and radiological characters were summarized and compared between two cohorts, as well as between patients at the Intensive Care Unit (ICU) and non-ICU within the COVID-19 cohort.

Results: For all 326 patients, the median age was 57.0 (IQR 45.0-69.0) and 48.2% was male, while 43.9% had comorbidities that included hypertension, diabetes, bronchitis, and heart diseases. Patients had cough (75.5%), fever (69.3%), expectoration (41.1%), dyspnea (19.3%), chest pain (18.7%) and fatigue (16.0%), etc. Both viral infections caused substantial blood abnormality, whereas the COVID-19 cohort showed a lower frequency of leukocytosis, neutrophilia or lymphocytopenia, but a higher chance of creatine kinase elevation. 7.7% of all patients possessed no abnormal sign in chest CT scans. For both infections, pulmonary lesions in radiological findings did not show any difference in their location or distribution. Nevertheless, compared to the influenza cohort, the COVID-19 cohort presented more diversity in CT features, where certain specific CT patterns showed significantly more frequency, including consolidation, crazy paving pattern, rounded opacities, air bronchogram, tree-in-bud sign, interlobular septal thickening, and bronchiolar wall thickening.

Conclusion: Differentiable clinical manifestations and CT patterns may help diagnose COVID-19 from influenza and gain a better understanding of both contagious respiratory illnesses. This article is protected by copyright.

Prevalence of anxiety/depression was investigated in 105 COVID-19 patients at 1-3 months from virological clearance by Hospital Anxiety and Depression Scale (HADS-A/D). 30% of patients displayed pathological HADS-A/D, 52.4% showed persistent symptoms. Pathological HADS-A/D patients more commonly reported symptom persistence, even after adjustment for age, gender, disease severity. Psychological assessments should be encouraged in COVID-19 patients’ follow-up. This article is protected by copyright.

A growing body of evidence indicates sex differences in the clinical outcomes of coronavirus disease 2019 (COVID-19)1-5. However, whether immune responses against SARS-CoV-2 differ between sexes, and whether such differences explain male susceptibility to COVID-19, is currently unknown. In this study, we examined sex differences in viral loads, SARS-CoV-2-specific antibody titers, plasma cytokines, as well as blood cell phenotyping in COVID-19 patients. By focusing our analysis on patients with moderate disease who had not received immunomodulatory medications, our results revealed that male patients had higher plasma levels of innate immune cytokines such as IL-8 and IL-18 along with more robust induction of non-classical monocytes. In contrast, female patients mounted significantly more robust T cell activation than male patients during SARS-CoV-2 infection, which was sustained in old age. Importantly, we found that a poor T cell response negatively correlated with patients’ age and was associated with worse disease outcome in male patients, but not in female patients. Conversely, higher innate immune cytokines in female patients associated with worse disease progression, but not in male patients. These findings reveal a possible explanation underlying observed sex biases in COVID-19, and provide an important basis for the development of a sex-based approach to the treatment and care of men and women with COVID-19.

Background: As a response to the COVID-19 pandemic, most countries have adopted measures of social distance, with the childhood population being one of the main focus of attention in these measures.

Methods: A rapid scoping review was carried out by searching PubMed to know if children are more contagious than adults, and the proportion of asymptomatic cases in children. Google Scholar and MedRxiv/bioRxiv were also searched. The time period was restricted from 1 December 2019 until 28 May 2020. Only studies published in English, Italian, French or Spanish were included.

Results: Fourteen out of 1099 identified articles were finally included. Studies included cases from China (n=9 to 2143), China and Taiwan (n=536), Korea (n=1), Vietnam (n=1), Australia (n=9), Geneva (n=40), the Netherlands (n=116), Ireland (n=3) and Spain (population-based study of IgG, n=8243). Although no complete data were available, between 15% and 55%-60% were asymptomatic, and 75%-100% of cases were from family transmission. Studies analysing school transmission showed children as not a driver of transmission. Prevalence of COVID-19 IgG antibody in children <15 years was lower than the general population in the Spanish study.

Conclusions: Children are not transmitters to a greater extent than adults. There is a need to improve the validity of epidemiological surveillance to solve current uncertainties, and to take into account social determinants and child health inequalities during and after the current pandemic.

Background: Respiratory failure and thromboembolism are frequent in SARS-CoV-2-infected patients. Vitamin K activates both hepatic coagulation factors and extrahepatic endothelial anticoagulant protein S, required for thrombosis prevention. In times of vitamin K insufficiency, hepatic procoagulant factors are preferentially activated over extrahepatic proteins. Vitamin K also activates matrix Gla protein (MGP), which protects against pulmonary and vascular elastic fiber damage. We hypothesized that vitamin K may be implicated in coronavirus disease 2019 (COVID-19), linking pulmonary and thromboembolic disease.

Methods: 135 hospitalized COVID-19 patients were compared with 184 historical controls. Poor outcome was defined as invasive ventilation and/or death. Inactive vitamin K-dependent MGP (dp-ucMGP) and prothrombin (PIVKA-II) were measured, inversely related to extrahepatic and hepatic vitamin K status, respectively. Desmosine was measured to quantify the rate of elastic fiber degradation. Arterial calcification severity was assessed by computed tomography.

Results: Dp-ucMGP was elevated in COVID-19 patients compared to controls (p<0.001), with even higher dp-ucMGP in patients with poor outcomes (p<0.001). PIVKA-II was normal in 82.1% of patients. Dp-ucMGP was correlated with desmosine (p<0.001), and coronary artery (p=0.002) and thoracic aortic (p<0.001) calcification scores.

Conclusions: Dp-ucMGP was severely increased in COVID-19 patients, indicating extrahepatic vitamin K insufficiency, which was related to poor outcome while hepatic procoagulant factor II remained unaffected. These data suggest a mechanism of pneumonia-induced extrahepatic vitamin K depletion leading to accelerated elastic fiber damage and thrombosis in severe COVID-19 due to impaired activation of MGP and endothelial protein S, respectively. A clinical trial could assess whether vitamin K administration improves COVID-19 outcomes

Aim: As the COVID-19 pandemic evolves, human milk banks world-wide continue to provide donor human milk to vulnerable infants who lack access to mother’s own milk. Under these circumstances, ensuring the safety of donor human milk is paramount, as the risk of vertical transmission of SARS-CoV-2 is not fully understood. Here, we investigate the inactivation of SARS-CoV-2 in human milk by pasteurisation and the stability of SARS-CoV-2 in human milk under cold storage.

Methods: SARS-CoV-2 was experimentally inoculated into human milk samples from healthy donors or into a control medium. Triplicates of each sample were layered onto uninfected cells after Holder pasteurisation (63°C for 30 min), heating to 56°C for 30 min, or after 48 h of storage at 4°C or -30°C. Infectious titres of virus were determined at 72 h post-infection by endpoint titration.

Results: Following heating to 63°C or 56°C for 30 min, replication competent (i.e. live) SARS-CoV-2 was undetected in both human milk and the control medium. Cold storage of SARS-CoV-2 in human milk (either at 4°C or -30°C) did not significantly impact infectious viral load over a 48 h period.

Conclusion: SARS-CoV-2 is effectively inactivated by Holder pasteurisation, suggesting that existing milk bank processes will effectively mitigate the risk of transmission of SARS-COV-2 to vulnerable infants through pasteurised donor human milk. The demonstrated stability of SARS-CoV-2 in refrigerated or frozen human milk may assist in the development of guidelines around safe expressing and storing of milk from COVID-19 infected mothers.

Background: The 2020 novel coronavirus (SARS-Cov-2) pandemic necessitates tailored recommendations addressing specific procedures for neonatal and paediatric transport of suspected or positive COVID-19 patients. The aim of this consensus statement is to define guidelines for safe clinical care for children needing inter-facility transport while making sure that the clinical teams involved are sufficiently protected from SARS-CoV-2.

Methods: A taskforce, composed of members of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC) Transport section and the European Society for Paediatric Research (ESPR), reviewed the published literature and used a rapid, two-step modified Delphi process to formulate recommendations regarding safety and clinical management during transport of COVID-19 patients.

Results: The joint taskforce consisted of a panel of 12 experts who reached an agreement on a set of 17 recommendations specifying pertinent aspects on neonatal and paediatric COVID-19 patient transport. These included: case definition, personal protective equipment, airway management, equipment and strategies for invasive and non-invasive ventilation, special considerations for incubator and open stretcher transports, parents on transport and decontamination of transport vehicles.

Conclusions: Our consensus recommendations aim to define current best-practice and should help guide transport teams dealing with infants and children with COVID-19 to work safely and effectively.

Impact: We present European consensus recommendations on pertinent measures for transporting infants and children in times of the coronavirus (SARS-Cov-2 /COVID-19) pandemic.A panel of experts reviewed the evidence around transporting infants and children with proven or suspected COVID-19. Specific guidance on aspects of personal protective equipment, airway management and considerations for incubator and open stretcher transports is presented.Based on scant evidence, best-practice recommendations for neonatal and paediatric transport teams are presented, aiming for the protection of teams and patients. We highlight gaps in knowledge and areas of future research.

Objective: To assess the impact of separation of SARS-CoV-2 PCR-positive mother-newborn dyads on breastfeeding outcomes.

Study design: This is an observational longitudinal cohort study of SARS-CoV-2 PCR-positive mothers and their infants at three NYU Langone Health hospitals from March 25, 2020 through May 30, 2020. Mothers were surveyed by telephone regarding pre-delivery feeding plans, in-hospital feeding, and home feeding of their neonates. Any change prompted an additional question to determine whether this change was due to COVID-19.

Results: Of the 160 mother-newborn dyads, 103 mothers were reached by telephone, and 85 consented to participate. No significant difference was observed in pre-delivery feeding plan between the separated and unseparated dyads (P = .268). Higher rates of breastfeeding were observed in the unseparated dyads compared with the separated dyads in the hospital (p<0.001), and at home (p=0.012). Only two mothers in each group reported expressed breast milk as the hospital feeding source (5.6% of unseparated vs 4.1% of separated). COVID-19 was more commonly cited as the reason for change among the separated compared with the unseparated group (49.0% vs 16.7%, p<0.001). When dyads were further stratified by symptom status into four groups (asymptomatic separated, asymptomatic unseparated, symptomatic separated, and symptomatic unseparated), results remained unchanged.

Conclusion: In the setting of COVID-19, separation of mother-newborn dyads impacts breastfeeding outcomes, with lower rates of breastfeeding both during hospitalization and at home following discharge compared with unseparated mothers and infants. No evidence of vertical transmission was observed; one case of postnatal transmission occurred from an unmasked symptomatic mother who held her infant at birth.

Objective: To evaluate the clinical manifestations and outcomes of neonates born to women who had Coronavirus Disease 2019 (COVID-19) during pregnancy.

Materials and methods: A systematic literature search was conducted on PubMed and Embase till April 15, 2020, by combining the terms (COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV-2, Novel Coronavirus, 2019-nCov, Wuhan pneumonia) and (pregnancy, pregnant women, mother, fetus, neonate, newborn, infant).

Results: We included 16 case series and 12 case reports describing a total of 223 pregnant women and 201 infants. Four newborns born to mothers affected by COVID-19 were reported to have laboratory-confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection within 48 hours after birth. However, Reverse Transcription-Polymerase Chain Reaction tests of the breast milk, placenta, amniotic fluids, and cord blood and maternal vaginal secretions were all negative for SARS-CoV-2 in the reported cases. Fetal death was reported in two cases, and 48 of 185 newborns (25.9%) were born prematurely. Infants born small for gestational age and low birth weight (< 2,500 g) accounted for 8.3% and 15.6% of reported cases, respectively. Birth asphyxia and respiratory distress syndrome were observed in 1.8% and 6.4% of neonates, respectively. There was one neonatal death due to intractable gastric bleeding among the SARS-CoV-2-negative infants.

Conclusions: Current evidence suggests that COVID-19 during pregnancy rarely affects fetal and neonatal mortality, but can be associated with adverse neonatal morbidities. Vertical transmission has not been observed in the majority of the reported cases. The infants born to mothers with COVID-19 are carefully monitored for accompanying complication, and quarantine of infected mothers is warranted.

The goal of perinatal medicine is to provide professionally responsible clinical management of the conditions and diagnoses of pregnant, fetal, and neonatal patients. The New York Declaration of the International Academy of Perinatal Medicine, “Women and children First – or Last?” was directed toward the ethical challenges of perinatal medicine in middle-income and low-income countries. The global COVID-19 pandemic presents common ethical challenges in all countries, independent of their national wealth. In this paper the World Association of Perinatal Medicine provides ethics-based guidance for professionally responsible advocacy for women and children first during the COVID-19 pandemic. We first present an ethical framework that explains ethical reasoning, clinically relevant ethical principles and professional virtues, and decision making with pregnant patients and parents. We then apply this ethical framework to evidence-based treatment and its improvement, planned home birth, ring-fencing obstetric services, attendance of spouse or partner at birth, and the responsible management of organizational resources. Perinatal physicians should focus on the mission of perinatal medicine to put women and children first and frame-shifting when necessary to put the lives and health of the population of patients served by a hospital first.

Limited data are available on pregnant women with COVID-19 and their neonates. We aimed to evaluate the epidemiological and clinical characteristics of newborns born to women infected with COVID-19. A multicenter cohort study was conducted among newborns born to mothers with COVID-19 in 34 neonatal intensive care units (NICUs) in Turkey. Pregnant women (n = 125) who had a positive RT-PCR test and their newborns were enrolled. Cesarean section, prematurity, and low-birthweight infant rates were 71.2%, 26.4%, and 12.8%, respectively. Eight of 125 mothers (6.4%) were admitted to an intensive care unit for mechanical ventilation, among whom six died (4.8%). Majority of the newborns (86.4%) were followed in isolation rooms in the NICU. Four of 120 newborns (3.3%) had a positive RT-PCR test result. Although samples taken on the first day were negative, one neonate became positive on the second day and the other two on the fifth day. Sample from deep tracheal aspirate was positive on the first day in an intubated case.Conclusion: COVID-19 in pregnant women has important impacts on perinatal and neonatal outcomes. Maternal mortality, higher rates of preterm birth and cesarean section, suspected risk of vertical transmission, and low rate of breastfeeding show that family support should be a part of the care in the NICU.Trial registration: ClinicalTrials.gov identifier: NCT04401540 What is Known: • The common property of previous reports was the conclusions on maternal outcomes, rather than neonatal outcomes. • Published data showed similar outcomes between COVID-19 pregnant women and others. What is New: • Higher maternal mortality, higher rates of preterm birth and cesarean section, suspected risk of vertical transmission especially in a case with deep tracheal aspiration during the intubation, and the possible role of maternal disease severity on the outcomes are remarkable findings of this study. • In contrast to recommendation for breastfeeding, parents’ preference to formula and expressed breast milk due to anxiety and lack of information shows that family support should be a part of the care in the NICU.

Background: COVID-19 has spread rapidly over the world. Little is known about the outcomes of infections inpregnant women. The management and characteristics of preterm infants born to COVID-19 mothers need to be clarified.

Methods: In this retrospective, single-center cohort study, we describe the clinical courses of 6 preterm infants born to COVID-19 mothers, the management protocol, and related outcomes.

Results: Six preterm infants were admitted to Tongji Hospital between January 23 and March 19, 2020. Gestational age ranged from 28+5 to 36+3 weeks. One late preterm infant was delivered early due to maternal dyspnea from COVID-19. Five infants were delivered by Caesarean section. None had perinatal asphyxia. Two infants required respiratory support due to respiratory distress syndrome and apnea of prematurity. All infants did not develop severe complications of prematurity and are negative for severe acute respiratory syndrome (SARS)-CoV-2 nucleic acid testing.

Conclusion: With an expedited and adequate delivery protocol, less invasive treatment principle, and active infection precautious, we found a limited impact of COVID-19 mothers on preterm delivery and neonatal short-term outcomes. The risk of vertical transmission of SARS-CoV-2 is low in preterm infants born to COVID-19 mothers if appropriate management is implemented.

Alcol in gravidanza: gravi problemi per il neonato, anche a lungo termine

Alcol e gravidanza, danni a figli anche a lungo termine