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1.
Clin Infect Dis ; 73(11): e3981-e3982, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1573984
3.
Ann Intern Med ; 174(3): JC28, 2021 03.
Article in English | MEDLINE | ID: covidwho-1512996

ABSTRACT

SOURCE CITATION: Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384:403-16. 33378609.


Subject(s)
COVID-19 , Vaccines , Adult , COVID-19 Vaccines , Humans , RNA, Messenger , SARS-CoV-2
4.
Ann Intern Med ; 174(11): JC125, 2021 11.
Article in English | MEDLINE | ID: covidwho-1497799

ABSTRACT

SOURCE CITATION: WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group; Shankar-Hari M, Vale CL, Godolphin PJ, et al. Association between administration of IL-6 antagonists and mortality among patients hospitalized for COVID-19: a meta-analysis. JAMA. 2021;326:499-518. 34228774.


Subject(s)
COVID-19 , Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/drug therapy , Humans , SARS-CoV-2
6.
Ann Intern Med ; 174(8): JC94, 2021 08.
Article in English | MEDLINE | ID: covidwho-1405520

ABSTRACT

SOURCE CITATION: Yan D, Zhang X, Chen C, et al. Characteristics of viral shedding time in SARS-CoV-2 infections: a systematic review and meta-analysis. Front Public Health. 2021;9:652842. 33816427.


Subject(s)
COVID-19 , Humans , Public Health , SARS-CoV-2 , Virus Shedding
9.
J Allergy Clin Immunol Pract ; 9(10): 3546-3567, 2021 10.
Article in English | MEDLINE | ID: covidwho-1275424

ABSTRACT

Concerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of international experts in anaphylaxis composed of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the World Health Organizstion (WHO) global coronavirus database, and the gray literature (inception, March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases per million (n = 41,000,000 vaccinations; 95% confidence interval [95% CI] 4.02-15.59; 26 studies, moderate certainty), the incidence of 0.15 cases per million patient-years (95% CI 0.11-0.2), and the sensitivity for PEG skin testing is poor, although specificity is high (15 studies, very low certainty). We recommend vaccination over either no vaccination or performing SARS-CoV-2 vaccine/excipient screening allergy testing for individuals without history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient, and a shared decision-making paradigm in consultation with an allergy specialist for individuals with a history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient. We recommend further research to clarify SARS-CoV-2 vaccine/vaccine excipient testing utility in individuals potentially allergic to SARS-CoV2 vaccines or their excipients.


Subject(s)
Anaphylaxis , COVID-19 , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , COVID-19 Vaccines , Consensus , GRADE Approach , Humans , RNA, Viral , SARS-CoV-2
10.
Ann Intern Med ; 174(5): JC50, 2021 05.
Article in English | MEDLINE | ID: covidwho-1215695

ABSTRACT

SOURCE CITATION: Madhi SA, Baillie V, Cutland CL, et al. Efficacy of the ChAdOx1 nCoV-19 Covid-19 vaccine against the B.1.351 variant. N Engl J Med. 2021. [Epub ahead of print.] 33725432.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , Humans , SARS-CoV-2 , South Africa
11.
Viruses ; 13(4)2021 04 16.
Article in English | MEDLINE | ID: covidwho-1194709

ABSTRACT

Coronavirus Disease 2019 (COVID-19) is a global pandemic caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). While detection of SARS-CoV-2 by polymerase chain reaction with reverse transcription (RT-PCR) is currently used to diagnose acute COVID-19 infection, serological assays are needed to study the humoral immune response to SARS-CoV-2. Anti-SARS-CoV-2 immunoglobulin (Ig)G/A/M antibodies against spike (S) protein and its receptor-binding domain (RBD) were characterized in recovered subjects who were RT-PCR-positive (n = 153) and RT-PCR-negative (n = 55) using an enzyme-linked immunosorbent assay (ELISA). These antibodies were also further assessed for their ability to neutralize live SARS-CoV-2 virus. Anti-SARS-CoV-2 antibodies were detected in 90.9% of resolved subjects up to 180 days post-symptom onset. Anti-S protein and anti-RBD IgG titers correlated (r = 0.5157 and r = 0.6010, respectively) with viral neutralization. Of the RT-PCR-positive subjects, 22 (14.3%) did not have anti-SARS-CoV-2 antibodies; and of those, 17 had RT-PCR cycle threshold (Ct) values > 27. These high Ct values raise the possibility that these indeterminate results are from individuals who were not infected or had mild infection that failed to elicit an antibody response. This study highlights the importance of serological surveys to determine population-level immunity based on infection numbers as determined by RT-PCR.


Subject(s)
Antibodies, Viral/immunology , COVID-19/immunology , SARS-CoV-2/immunology , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Neutralizing/blood , Antibodies, Neutralizing/immunology , Antibodies, Viral/blood , COVID-19/blood , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Nucleic Acid Testing , COVID-19 Serological Testing , Female , Humans , Immunoglobulin Isotypes/blood , Immunoglobulin Isotypes/immunology , Male , Middle Aged , Spike Glycoprotein, Coronavirus/immunology , Young Adult
12.
Ann Intern Med ; 174(3): JC29, 2021 03.
Article in English | MEDLINE | ID: covidwho-1112857

ABSTRACT

SOURCE CITATION: Voysey M, Clemens SA, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397:99-111. 33306989.


Subject(s)
COVID-19 , Vaccines , Adult , Brazil , COVID-19 Vaccines , Humans , SARS-CoV-2 , South Africa , United Kingdom
13.
Ann Intern Med ; 174(3): JC28, 2021 03.
Article in English | MEDLINE | ID: covidwho-1112856

ABSTRACT

SOURCE CITATION: Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384:403-16. 33378609.


Subject(s)
COVID-19 , Vaccines , Adult , COVID-19 Vaccines , Humans , RNA, Messenger , SARS-CoV-2
14.
Ann Intern Med ; 174(2): JC15, 2021 02.
Article in English | MEDLINE | ID: covidwho-1067958

ABSTRACT

SOURCE CITATION: Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383:2603-15. 33301246.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , Humans , RNA, Messenger , SARS-CoV-2
16.
PLoS One ; 16(1): e0244778, 2021.
Article in English | MEDLINE | ID: covidwho-1013217

ABSTRACT

BACKGROUND: Populations such as healthcare workers (HCW) that are unable to practice physical distancing are at high risk of acquiring Coronavirus disease-2019 (COVID-19). In these cases pharmacological prophylaxis would be a solution to reduce severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) transmission. Hydroxychloroquine has in vitro antiviral properties against SARS CoV-2. We therefore sought to determine the efficacy and safety of hydroxychloroquine as prophylaxis for COVID-19. METHODS AND FINDINGS: We electronically searched EMBASE, MEDLINE, the Cochrane COVID-19 Register of Controlled Trials, Epistemonikos COVID-19, clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform up to September 28th, 2020 for randomized controlled trials (RCTs). We calculated pooled relative risks (RRs) for dichotomous outcomes with the corresponding 95% confidence intervals (CIs) using a random-effect model. We identified four RCTs (n = 4921) that met our eligibility criteria. The use of hydroxychloroquine, compared to placebo, did not reduce the risks of developing COVID-19 (RR 0.82, 95% CI 0.65 to 1.04, moderate certainty), hospitalization (RR 0.72, 95% CI 0.34 to 1.50, moderate certainty), or mortality (RR 3.26, 95% CI 0.13 to 79.74, low certainty), however, hydroxychloroquine use increased the risk of adverse events (RR 2.76, 95% CI 1.38 to 5.55, moderate certainty). CONCLUSION: Although pharmacologic prophylaxis is an attractive preventive strategy against COVID-19, the current body of evidence failed to show clinical benefit for prophylactic hydroxychloroquine and showed a higher risk of adverse events when compared to placebo or no prophylaxis.


Subject(s)
COVID-19/drug therapy , Hydroxychloroquine/adverse effects , Hydroxychloroquine/therapeutic use , Antibiotic Prophylaxis/methods , Antiviral Agents/therapeutic use , COVID-19/metabolism , Humans , Hydroxychloroquine/metabolism , Pre-Exposure Prophylaxis/methods , Randomized Controlled Trials as Topic , SARS-CoV-2/pathogenicity
18.
Open Forum Infect Dis ; 7(11): ofaa500, 2020 Nov.
Article in English | MEDLINE | ID: covidwho-873054

ABSTRACT

Background: Use of hydroxychloroquine in hospitalized patients with coronavirus disease 2019 (COVID-19), especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from 3 outpatient randomized clinical trials. Methods: We conducted 3 randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, postexposure prophylaxis, and early treatment for COVID-19 using an internet-based design. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings. Results: We enrolled 2795 participants. The median age of research participants (interquartile range) was 40 (34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2544 (91%) participants reported side effect data, and 748 (29%) reported at least 1 medication side effect. Side effects were reported in 40% with once-daily, 36% with twice-weekly, 31% with once-weekly hydroxychloroquine, compared with 19% with placebo. The most common side effects were upset stomach or nausea (25% with once-daily, 19% with twice-weekly, and 18% with once-weekly hydroxychloroquine, vs 11% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for once-daily, 17% twice-weekly, and 13% once-weekly hydroxychloroquine, vs 7% for placebo). Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly hydroxychloroquine. No sudden deaths occurred. Conclusions: Data from 3 outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials, in cohorts of healthy outpatients, can safely investigate whether hydroxychloroquine is efficacious for COVID-19. ClinicalTrialsgov Identifier: NCT04308668 for postexposure prophylaxis and early treatment trials; NCT04328467 for pre-exposure prophylaxis trial.

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