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1.
Clin Infect Dis ; 2021 Nov 17.
Article in English | MEDLINE | ID: covidwho-2017782

ABSTRACT

BACKGROUND: The purpose of this study was to estimate prevalence of asymptomatic 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. METHODS: This was a 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. RESULTS: Data were collected from nine 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 unit. 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). CONCLUSIONS: Given 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.

2.
Am J Obstet Gynecol ; 2022 Aug 12.
Article in English | MEDLINE | ID: covidwho-1982487

ABSTRACT

BACKGROUND: SARS-CoV2 infection during pregnancy is associated with adverse pregnancy outcomes including fetal death and preterm birth. It is not known whether that risk occurs only during the time of acute infection or whether risk persists later in pregnancy. OBJECTIVE: The goal of this analysis was to evaluate whether the risk of SARS-CoV-2 infection during pregnancy persists after acute maternal illness. STUDY DESIGN: A retrospective cohort study of pregnant patients with and without SARS-CoV2 infection delivering at 17 hospitals in the United States between March and December 2020. Patients experiencing a SARS-CoV-2 positive test at or prior to 28 weeks' gestation with a subsequent delivery hospitalization were compared with those without a positive SAR-CoV-2 test at the same hospitals with randomly selected delivery days during the same period. Deliveries occurring <20 weeks' gestation in both groups were excluded. Study outcomes included fetal or neonatal death, preterm birth less than 37 weeks' gestation and less than 34 weeks' gestation, hypertensive disorders of pregnancy, any major congenital malformation, and size for gestational age less than 5th or 10th percentiles at birth based on published standards. Hypertensive disorders of pregnancy that were collected included hypertensive disorders of pregnancy and preeclampsia with severe features, both overall and with delivery <37 weeks' gestation. RESULTS: Of 2,326 patients who tested positive for SARS-CoV-2 during pregnancy and were at least 20 weeks' gestation at delivery from March through December 2020, 402 patients (delivering 414 fetuses/neonates) were SARS-CoV-2 positive before 28 weeks' gestation and prior to their admission for delivery; they were compared to 11,705 patients without a positive SARS-CoV-2 test. In adjusted analyses, those with SARS-CoV-2 prior to 28 weeks' had a subsequent increased risk of fetal/neonatal death [2·9% vs 1·5%, adjusted relative risk (aRR) 1·97, 95% confidence interval (CI),1·01 - 3·85], preterm birth <37 weeks' (19·6% vs 13·8%, aRR, 1·29; 95%CI, 1·02 - 1·63) and hypertensive disorders of pregnancy with delivery less than 37 weeks' gestation (7·2% vs 4·1%, aRR 1·74, 95% CI 1·19-2·55). There were no significant differences in the rates of preterm birth <34 weeks', any major congenital malformation, size for gestational age less than the 5th or 10th percentiles. There were also no significant differences in the rate of gestational hypertension overall or in preeclampsia with severe features. CONCLUSION: There is a modest increase in risk of adverse pregnancy outcomes subsequent to SARS-CoV-2 infection.

4.
JAMA ; 327(8): 748-759, 2022 02 22.
Article in English | MEDLINE | ID: covidwho-1739090

ABSTRACT

Importance: It remains unknown whether SARS-CoV-2 infection specifically increases the risk of serious obstetric morbidity. Objective: To evaluate the association of SARS-CoV-2 infection with serious maternal morbidity or mortality from common obstetric complications. Design, Setting, and Participants: Retrospective cohort study of 14 104 pregnant and postpartum patients delivered between March 1, 2020, and December 31, 2020 (with final follow-up to February 11, 2021), at 17 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Gestational Research Assessments of COVID-19 (GRAVID) Study. All patients with SARS-CoV-2 were included and compared with those without a positive SARS-CoV-2 test result who delivered on randomly selected dates over the same period. Exposures: SARS-CoV-2 infection was based on a positive nucleic acid or antigen test result. Secondary analyses further stratified those with SARS-CoV-2 infection by disease severity. Main Outcomes and Measures: The primary outcome was a composite of maternal death or serious morbidity related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2. The main secondary outcome was cesarean birth. Results: Of the 14 104 included patients (mean age, 29.7 years), 2352 patients had SARS-CoV-2 infection and 11 752 did not have a positive SARS-CoV-2 test result. Compared with those without a positive SARS-CoV-2 test result, SARS-CoV-2 infection was significantly associated with the primary outcome (13.4% vs 9.2%; difference, 4.2% [95% CI, 2.8%-5.6%]; adjusted relative risk [aRR], 1.41 [95% CI, 1.23-1.61]). All 5 maternal deaths were in the SARS-CoV-2 group. SARS-CoV-2 infection was not significantly associated with cesarean birth (34.7% vs 32.4%; aRR, 1.05 [95% CI, 0.99-1.11]). Compared with those without a positive SARS-CoV-2 test result, moderate or higher COVID-19 severity (n = 586) was significantly associated with the primary outcome (26.1% vs 9.2%; difference, 16.9% [95% CI, 13.3%-20.4%]; aRR, 2.06 [95% CI, 1.73-2.46]) and the major secondary outcome of cesarean birth (45.4% vs 32.4%; difference, 12.8% [95% CI, 8.7%-16.8%]; aRR, 1.17 [95% CI, 1.07-1.28]), but mild or asymptomatic infection (n = 1766) was not significantly associated with the primary outcome (9.2% vs 9.2%; difference, 0% [95% CI, -1.4% to 1.4%]; aRR, 1.11 [95% CI, 0.94-1.32]) or cesarean birth (31.2% vs 32.4%; difference, -1.4% [95% CI, -3.6% to 0.8%]; aRR, 1.00 [95% CI, 0.93-1.07]). Conclusions and Relevance: Among pregnant and postpartum individuals at 17 US hospitals, SARS-CoV-2 infection was associated with an increased risk for a composite outcome of maternal mortality or serious morbidity from obstetric complications.


Subject(s)
COVID-19/complications , Hypertension, Pregnancy-Induced , Maternal Mortality , Pregnancy Complications, Infectious , Adult , COVID-19/mortality , Female , Humans , Postpartum Hemorrhage/mortality , Postpartum Period , Pregnancy , Retrospective Studies , United States/epidemiology
5.
J Matern Fetal Neonatal Med ; : 1-3, 2022 Feb 16.
Article in English | MEDLINE | ID: covidwho-1692378

ABSTRACT

This study sought to assess the impact of COVID-19 on placental vasculature in the context of maternal symptomatology - comparing asymptomatic to symptomatic pregnant patients - and disease severity - comparing pregnant patients with mild, moderate, severe, and critical COVID-19 infection. PCR-confirmed COVID-19 positive pregnant patients in a single health system who delivered between 3/2020-5/2021 included. All patients had positive COVID test and delivered during the study period. Primary outcome was incidence of any vascular malperfusion on placental pathology. Secondary outcomes were FVM and MVM on placental pathology. Placental pathology compared between symptomatic (sCOVID) and asymptomatic (aCOVID) patients. Secondary analysis of symptomatic patients, comparing placental pathology between mild disease(mCOVID) and worse disease(moderate, severe, or critical-defined by 2020 NIH guidelines) (dCOVID), also performed. Of 112 patients, 53 (47%) had symptoms. Twenty-seven (24.1%) patients had evidence of vascular malperfusion; 26 (23.2%) had MVM. When comparing aCOVID and sCOVID patients, no difference in rate of vascular malperfusion identified, nor any differences in rates of FVM or MVM. Among sCOVID patients (n = 53), 39 (74%) had mCOVID and 14 (26%) had dCOVID (moderate n = 4, severe n = 9, critical n = 1). Patients with dCOVID had earlier median delivery GA (37.4wks vs 39.2wks, p = .03). No difference in latency from diagnosis to delivery seen between mCOVID and dCOVID groups (4.4 vs 3.0wks, p = .96). Twelve (30.8%) patients had vascular malperfusion on pathology, all had mCOVID (p = .02). Eleven (28.2%) mCOVID patients had MVM; no dCOVID patients had evidence of vascular malperfusion (p = .03). No difference in FVM was found between cohorts. Symptomatic COVID-19 infection did not impact placental vasculature differently than asymptomatic infection, even when stratifying by trimester of infection. Among pregnant patients with symptomatic COVID-19, mild disease was associated with placental vascular changes on the maternal side while severe disease was not. Further studies are needed to understand the implications of these findings.

7.
Clin Infect Dis ; 2021 Nov 17.
Article in English | MEDLINE | ID: covidwho-1522162

ABSTRACT

BACKGROUND: The purpose of this study was to estimate prevalence of asymptomatic 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. METHODS: This was a 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. RESULTS: Data were collected from nine 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 unit. 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). CONCLUSIONS: Given 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.

8.
Ann Intern Med ; 174(8): 1151-1158, 2021 08.
Article in English | MEDLINE | ID: covidwho-1481184

ABSTRACT

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.


Subject(s)
COVID-19/therapy , Pandemics , Practice Guidelines as Topic , Advisory Committees , COVID-19/drug therapy , COVID-19/epidemiology , Child , Data Interpretation, Statistical , Drug Approval , Evidence-Based Medicine , Female , Humans , Interprofessional Relations , National Institutes of Health (U.S.) , Pregnancy , SARS-CoV-2 , Stakeholder Participation , United States
9.
Obstet Gynecol ; 137(4): 571-580, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1322672

ABSTRACT

OBJECTIVE: To describe coronavirus disease 2019 (COVID-19) severity in pregnant patients and evaluate the association between disease severity and perinatal outcomes. METHODS: We conducted an observational cohort study of all pregnant patients with a singleton gestation and a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who delivered at 1 of 33 U.S. hospitals in 14 states from March 1 to July 31, 2020. Disease severity was classified by National Institutes of Health criteria. Maternal, fetal, and neonatal outcomes were abstracted by centrally trained and certified perinatal research staff. We evaluated trends in maternal characteristics and outcomes across COVID-19 severity classes and associations between severity and outcomes by multivariable modeling. RESULTS: A total of 1,219 patients were included: 47% asymptomatic, 27% mild, 14% moderate, 8% severe, 4% critical. Overall, 53% were Hispanic; there was no trend in race-ethnicity distribution by disease severity. Those with more severe illness had older mean age, higher median body mass index, and pre-existing medical comorbidities. Four maternal deaths (0.3%) were attributed to COVID-19. Frequency of perinatal death or a positive neonatal SARS-CoV-2 test result did not differ by severity. Adverse perinatal outcomes were more frequent among patients with more severe illness, including 6% (95% CI 2-11%) incidence of venous thromboembolism among those with severe-critical illness compared with 0.2% in mild-moderate and 0% in asymptomatic (P<.001 for trend across severity). In adjusted analyses, severe-critical COVID-19 was associated with increased risk of cesarean birth (59.6% vs 34.0%, adjusted relative risk [aRR] 1.57, 95% CI 1.30-1.90), hypertensive disorders of pregnancy (40.4% vs 18.8%, aRR 1.61, 95% CI 1.18-2.20), and preterm birth (41.8% vs 11.9%, aRR 3.53, 95% CI 2.42-5.14) compared with asymptomatic patients. Mild-moderate COVID-19 was not associated with adverse perinatal outcomes compared with asymptomatic patients. CONCLUSION: Compared with pregnant patients with SARS-CoV-2 infection without symptoms, those with severe-critical COVID-19, but not those with mild-moderate COVID-19, were at increased risk of perinatal complications.


Subject(s)
COVID-19/epidemiology , Patient Acuity , Pregnancy Complications, Infectious/epidemiology , Adult , Asymptomatic Infections , Body Mass Index , COVID-19/complications , COVID-19/diagnosis , Cesarean Section/statistics & numerical data , Cohort Studies , Comorbidity , Female , Humans , Hypertension, Pregnancy-Induced/epidemiology , Infant, Newborn , Maternal Age , Maternal Mortality , Perinatal Mortality , Pregnancy , Pregnancy Complications, Infectious/virology , Premature Birth/epidemiology , Risk Factors , SARS-CoV-2 , United States/epidemiology , Venous Thromboembolism/epidemiology , Venous Thromboembolism/virology , Young Adult
12.
Obstet Gynecol ; 137(4): 571-580, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1075619

ABSTRACT

OBJECTIVE: To describe coronavirus disease 2019 (COVID-19) severity in pregnant patients and evaluate the association between disease severity and perinatal outcomes. METHODS: We conducted an observational cohort study of all pregnant patients with a singleton gestation and a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who delivered at 1 of 33 U.S. hospitals in 14 states from March 1 to July 31, 2020. Disease severity was classified by National Institutes of Health criteria. Maternal, fetal, and neonatal outcomes were abstracted by centrally trained and certified perinatal research staff. We evaluated trends in maternal characteristics and outcomes across COVID-19 severity classes and associations between severity and outcomes by multivariable modeling. RESULTS: A total of 1,219 patients were included: 47% asymptomatic, 27% mild, 14% moderate, 8% severe, 4% critical. Overall, 53% were Hispanic; there was no trend in race-ethnicity distribution by disease severity. Those with more severe illness had older mean age, higher median body mass index, and pre-existing medical comorbidities. Four maternal deaths (0.3%) were attributed to COVID-19. Frequency of perinatal death or a positive neonatal SARS-CoV-2 test result did not differ by severity. Adverse perinatal outcomes were more frequent among patients with more severe illness, including 6% (95% CI 2-11%) incidence of venous thromboembolism among those with severe-critical illness compared with 0.2% in mild-moderate and 0% in asymptomatic (P<.001 for trend across severity). In adjusted analyses, severe-critical COVID-19 was associated with increased risk of cesarean birth (59.6% vs 34.0%, adjusted relative risk [aRR] 1.57, 95% CI 1.30-1.90), hypertensive disorders of pregnancy (40.4% vs 18.8%, aRR 1.61, 95% CI 1.18-2.20), and preterm birth (41.8% vs 11.9%, aRR 3.53, 95% CI 2.42-5.14) compared with asymptomatic patients. Mild-moderate COVID-19 was not associated with adverse perinatal outcomes compared with asymptomatic patients. CONCLUSION: Compared with pregnant patients with SARS-CoV-2 infection without symptoms, those with severe-critical COVID-19, but not those with mild-moderate COVID-19, were at increased risk of perinatal complications.


Subject(s)
COVID-19/epidemiology , Patient Acuity , Pregnancy Complications, Infectious/epidemiology , Adult , Asymptomatic Infections , Body Mass Index , COVID-19/complications , COVID-19/diagnosis , Cesarean Section/statistics & numerical data , Cohort Studies , Comorbidity , Female , Humans , Hypertension, Pregnancy-Induced/epidemiology , Infant, Newborn , Maternal Age , Maternal Mortality , Perinatal Mortality , Pregnancy , Pregnancy Complications, Infectious/virology , Premature Birth/epidemiology , Risk Factors , SARS-CoV-2 , United States/epidemiology , Venous Thromboembolism/epidemiology , Venous Thromboembolism/virology , Young Adult
14.
Am J Obstet Gynecol MFM ; 3(2): 100295, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1053171

ABSTRACT

As of December 1, 2020, nearly 64 million people have been infected with the severe acute respiratory syndrome coronavirus 2 worldwide with nearly 1.5 million global deaths. The impact of this virus has continued to overwhelm hospital infrastructure and demanded remodeling of healthcare systems. With rising concerns for a third, and possibly the largest, wave of individuals infected with the virus, national leaders are continuing to seek avenues by which we can further limit disease transmission and prevent infection with the use of vaccination. To our knowledge, no clinical trial evaluating vaccines to prevent coronavirus disease 2019 has included pregnant women. In December 2020, it was anticipated that the Food and Drug Administration will approve at least 1 or 2 mRNA-based coronavirus disease 2019 vaccine under the Emergency Use Authorization based on phase 3 clinical trial efficacy data. Both Pfizer and Moderna have manufactured mRNA-based vaccines with 95% and 94.1% efficacy against the severe acute respiratory syndrome coronavirus 2. AstraZeneca has manufactured a vaccine using a viral vector demonstrating early efficacy as well, and this next-generation platform has previously been utilized with the Ebola vaccine and safely administered during pregnancy with an acceptable safety profile. Approval of these vaccines will have a tremendous impact on the ongoing pandemic, yet there remains a lack of data for use of coronavirus disease 2019 vaccine in pregnant women. In this article, we seek to discuss the available data regarding treatment and prevention of coronavirus disease 2019 in pregnancy and address the growing questions regarding how best to approach vaccine access and administration in the pregnant population.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/drug therapy , COVID-19/prevention & control , Pregnant Women , Female , Humans , Pregnancy , SARS-CoV-2/immunology
16.
Contemporary OB/GYN ; 65(4):11-12, 2020.
Article | CINAHL | ID: covidwho-824510
18.
J Rheumatol ; 2020 May 11.
Article in English | MEDLINE | ID: covidwho-251108

ABSTRACT

OBJECTIVE: To characterize hydroxychloroquine (HCQ) exposure in patients with rheumatic disease receiving longterm HCQ compared to target concentrations with reported antiviral activity against the coronavirus disease 2019 caused by SARS-CoV-2 (COVID-19). METHODS: We evaluated total HCQ concentrations in serum and plasma from published literature values, frozen serum samples from a pediatric systemic lupus erythematosus trial, and simulated concentrations using a published pharmacokinetic model during pregnancy. For each source, we compared observed or predicted HCQ concentrations to target concentrations with reported antiviral activity against SARS-CoV-2. RESULTS: The average total serum/plasma HCQ concentrations were below the lowest SARS-CoV-2 target of 0.48 mg/l in all studies. Assuming the highest antiviral target exposure (total plasma concentration of 4.1 mg/l), all studies had about one-tenth the necessary concentration for in vitro viral inhibition. Pharmacokinetic model simulations confirmed that pregnant adults receiving common dosing for rheumatic diseases did not achieve target exposures; however, the models predict that a dosage of 600 mg once a day during pregnancy would obtain the lowest median target exposure for most patients after the first dose. CONCLUSION: We found that the average patient receiving treatment with HCQ for rheumatic diseases, including children and non-pregnant/pregnant adults, are unlikely to achieve total serum or plasma concentrations shown to inhibit SARS-CoV-2 in vitro. Nevertheless, patients receiving HCQ long term may have tissue concentrations far exceeding that of serum/plasma. Because the therapeutic window for HCQ in the setting of SARS-CoV-2 is unknown, well-designed clinical trials that include patients with rheumatic disease are urgently needed to characterize the efficacy, safety, and target exposures for HCQ.

19.
Am J Perinatol ; 37(8): 773-779, 2020 06.
Article in English | MEDLINE | ID: covidwho-72491

ABSTRACT

The novel coronavirus disease 2019 (COVID-19) is a growing pandemic that is impacting daily life across the globe. Though disease is often mild, in high-risk populations, severe disease often leads to intubation, intensive care admission (ICU) admission, and in many cases death. The implications for pregnancy remain largely unknown. Early data suggest that COVID-19 may not pose increased risk in the pregnant population. Vertical transmission has not been confirmed. Because no treatment, no vaccine and no herd immunity exist, social distancing is the best mechanism available to protect patients and health care workers from infection. This review will discuss what is known about the virus as it relates to pregnancy and then consider management considerations based on these data. KEY POINTS: · COVID-19 severity in pregnancy is unclear.. · Social distancing is the best protective mechanism.. · No clear evidence of vertical transmission exists.. · Mother/baby separation avoids transmission..


Subject(s)
Coronavirus Infections , Infection Control , Infectious Disease Transmission, Vertical/prevention & control , Pandemics , Pneumonia, Viral , Pregnancy Complications, Infectious , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Female , Humans , Infant, Newborn , Infection Control/methods , Infection Control/organization & administration , Pandemics/prevention & control , Pneumonia, Viral/diagnosis , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/therapy , Pregnancy Complications, Infectious/virology , SARS-CoV-2
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