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Abstract: Importance: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. Methods: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility– and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross– validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. Discussion: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.

BackgroundThe purpose of this study was to estimate prevalence of asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among patients admitted to obstetric inpatient units throughout the United States as detected by universal screening. We sought to describe the relationship between obstetric inpatient asymptomatic infection rates and publicly available surrounding community infection rates.MethodsA cross-sectional study in which medical centers reported rates of positive SARS-CoV-2 testing in asymptomatic pregnant and immediate postpartum patients over a 1-3-month time span in 2020. Publicly reported SARS-CoV-2 case rates from the relevant county and state for each center were collected from the COVID Act Now dashboard and the COVID Tracking Project for correlation analysis.ResultsData were collected from 9 health centers, encompassing 18 hospitals. Participating health centers were located in Alabama, California, Illinois, Louisiana, New Jersey, North Carolina, Pennsylvania, Rhode Island, Utah, and Washington State. Each hospital had an active policy for universal SARS-CoV-2 testing on obstetric inpatient units. A total of 10 147 SARS-CoV-2 tests were administered, of which 124 were positive (1.2%). Positivity rates varied by site, ranging from 0-3.2%. While SARS-CoV-2 infection rates were lower in asymptomatic obstetric inpatient groups than the surrounding communities, there was a positive correlation between positivity rates in obstetric inpatient units and their surrounding county (P=.003, r=.782) and state (P=.007, r=.708).ConclusionsGiven the correlation between community and obstetric inpatient rates, the necessity of SARS-CoV-2-related healthcare resource utilization in obstetric inpatient units may be best informed by surrounding community infection rates.

BackgroundThe benefits and safety of the treatment of mild chronic hypertension (blood pressure,

The development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.

Objective This study aimed to test the hypothesis that being pregnant and delivering during the coronavirus disease 2019 (COVID-19) pandemic was associated with changes in gestational weight gain (GWG) or frequency of small- (SGA) or large-for-gestational-age (LGA) neonates. Study Design Secondary analysis of a multicenter observational cohort comparing pregnant people who delivered during the COVID-19 pandemic (June–December 2020) to people who delivered prior to the pandemic (March–December 2019). Those with multiple gestations, fetuses with major congenital anomalies, implausible GWG values, unavailable body mass index (BMI), or who were severe acute respiratory syndrome coronavirus-2-positive were excluded. The primary outcome was frequency of optimal recommended GWG based on prepregnancy BMI. Neonatal outcomes included birth weight, ponderal index, and frequency of SGA, LGA, and small head circumference for live births. Multivariable regression analysis was used to assess associations between exposure to the pandemic and outcomes. Results A total of 10,717 pregnant people were included in our analysis. A total of 4,225 pregnant people were exposed to the pandemic and 6,492 pregnant people delivered prior to the COVID-19 pandemic. Pregnant people exposed to the pandemic were older and more likely to have gestational diabetes. The frequency of appropriate GWG was 28.0% during the pandemic and 27.6% before the pandemic (adjusted odds ratio [aOR]: 1.02, 95% confidence interval [CI]: 0.93–1.11). Excessive GWG was more likely (54.9 vs. 53.1%; aOR: 1.08, 95% CI: 1.001–1.17), and inadequate GWG was less likely during the pandemic (17.0 vs. 19.3%; aOR: 0.86, 95% CI: 0.77–0.95). The frequency of SGA was 5.4% during the pandemic and 6.1% before the pandemic (aOR: 0.90, 95% CI: 0.76–1.06), and the frequency of LGA was 16.0% during the pandemic versus 15.0% before the pandemic (aOR: 1.06, 95% CI: 0.95–1.18). Other neonatal outcomes including birth weight percentile (62.1 [35.8–83.2] vs. 60.2 [34.4–82.2]; adjusted mean difference (aMD) = 1.50, 95% CI: −0.28 to 3.29), ponderal index (2.6 g/cm 3 [2.4–2.8] in both groups; aMD = 0.01, 95% CI: 0.00–0.02), and small head circumference for livebirths (<10th percentile [8.2 vs. 8.1%; aOR: 1.03, 95% CI: 0.89–1.19], <3rd percentile [3.5 vs. 3.1%; aOR: 1.16, 95% CI: 0.93–1.44]) were similar between groups as well. Conclusion Being pregnant and delivering during the COVID-19 pandemic was associated with a higher likelihood of excessive GWG and a lower likelihood of inadequate GWG. Key Points Delivering during the COVID-19 pandemic was associated with higher likelihood of excessive GWG. Delivering during the COVID-19 pandemic was associated with lower likelihood of inadequate GWG. COVID-19 pandemic was not associated with changes in frequency of SGA or LGA. [ABSTRACT FROM AUTHOR]

Objective This study aimed to develop a prediction model that estimates the probability that a pregnant person who has had asymptomatic or mild coronavirus disease 2019 (COVID-19) prior to delivery admission will progress in severity to moderate, severe, or critical COVID-19. Study Design This was a secondary analysis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients who delivered from March through December 2020 at hospitals across the United States. Those eligible for this analysis presented for delivery with a current or previous asymptomatic or mild SARS-CoV-2 infection. The primary outcome was moderate, severe, or critical COVID-19 during the delivery admission through 42 days postpartum. The prediction model was developed and internally validated using stratified cross-validation with stepwise backward elimination, incorporating only variables that were known on the day of hospital admission. Results Of the 2,818 patients included, 26 (0.9%; 95% confidence interval [CI], 0.6–1.3%) developed moderate–severe–critical COVID-19 during the study period. Variables in the prediction model were gestational age at delivery admission (adjusted odds ratio [aOR], 1.15; 95% CI, 1.08–1.22 per 1-week decrease), a hypertensive disorder in a prior pregnancy (aOR 3.05; 95% CI, 1.25–7.46), and systolic blood pressure at admission (aOR, 1.04; 95% CI, 1.02–1.05 per mm Hg increase). This model yielded an area under the receiver operating characteristic curve of 0.82 (95% CI, 0.72–0.91). Conclusion Among individuals presenting for delivery who had asymptomatic–mild COVID-19, gestational age at delivery admission, a hypertensive disorder in a prior pregnancy, and systolic blood pressure at admission were predictive of delivering with moderate, severe, or critical COVID-19. This prediction model may be a useful tool to optimize resources for SARS-CoV-2-infected pregnant individuals admitted for delivery. Key Points Three factors were associated with delivery with more severe COVID-19. The developed model yielded an area under the receiver operating characteristic curve of 0.82 and model fit was good. The model may be useful tool for SARS-CoV-2 infected pregnancies admitted for delivery. [ABSTRACT FROM AUTHOR]

Background: Recent data in nonpregnant individuals suggest a protective effect of influenza vaccination against SARS‐CoV‐2 infection and its severity. Objectives: Our primary objective was to evaluate whether influenza vaccination was associated with COVID‐19 severity and pregnancy and neonatal outcomes among those infected with SARS‐CoV‐2. The secondary objective was to examine the association between influenza vaccination and SARS‐CoV‐2 infection. Study Design: Secondary analysis of a multicenter retrospective cohort of pregnant people who tested positive for SARS‐CoV‐2 between March and August 2020, and a cohort of random deliveries during the same time period. The associations between 2019 influenza vaccination and the primary outcome of moderate‐to‐critical COVID‐19 as well as maternal and perinatal outcomes were examined among all people who tested positive for SARS‐CoV‐2 between March and August 2020. The association between 2019 influenza vaccination and having a positive SARS‐CoV‐2 test was examined among a cohort of individuals who delivered on randomly selected dates between March and August 2020. Univariable and multivariable analyses were performed. Results: Of 2325 people who tested positive for SARS‐CoV‐2, 1068 (45.9%) were vaccinated against influenza in 2019. Those who received the influenza vaccine were older, leaner, more likely to have private insurance, and identify as White or Hispanic. They were less likely to smoke tobacco and identify as Black. Overall, 419 (18.0%) had moderate, 193 (8.3%) severe, and 52 (2.2%) critical COVID‐19. There was no association between influenza vaccination and moderate‐to‐critical COVID‐19 (29.2% vs. 28.0%, adjusted OR 1.10, 95% CI 0.90–1.34) or adverse maternal and perinatal outcomes among those who tested positive. Of 8152 people who delivered in 2020, 4658 (57.1%) received the influenza vaccine. Prior vaccination was not associated with a difference in the odds of SARS‐CoV‐2 infection (3.8% vs. 4.2%, adjusted OR 0.94, 95% CI 0.74–1.19). Conclusion: Prior influenza vaccination was not associated with decreased severity of COVID‐19 or lower odds of SARS‐CoV‐2 infection in pregnancy. [ABSTRACT FROM AUTHOR]

A vaccination against respiratory syncytial virus (RSV) was approved by the U.S. Food and Drug Administration recently and is now recommended during pregnancy at 32–36 weeks of gestation for patients who will deliver during RSV season if the infant is not anticipated to receive nirsevimab. Respiratory syncytial virus (RSV) is a significant cause of infant morbidity and mortality worldwide with peak hospitalization rates for RSV-mediated illnesses between 2 and 3 months of life. Until very recently, prevention strategies for RSV involved primarily passive immunization of neonates at high risk with monoclonal antibodies and promotion of breastfeeding. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices now recommends passive immunization of all neonates with monoclonal antibodies during RSV season, and the American Association of Pediatrics has endorsed this practice. The U.S. Food and Drug Administration (FDA) recently approved a vaccination for RSV in pregnancy. The CDC's Advisory Committee on Immunization Practices has recently recommended RSV vaccination for all pregnant patients between 32 and 36 weeks of gestation who are anticipated to deliver during RSV season if they are not planning nirsevimab for their infants. This recommendation has been endorsed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. In this clinical perspective, we review the scientific evidence, potential concerns, challenges, and future considerations for RSV vaccination in pregnancy. [ABSTRACT FROM AUTHOR]