ArticleOpen forum infectious diseases2020
Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
Article in Open forum infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers, 9 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Who cites it
35 citing papers in PubMed, 9 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- COVID-19 in comorbid chronic diseased patients, pregnant and lactating women: pathophysiology, available drug treatment, and the most suitable protocol regimen in each group.Inflammopharmacology · 2025Pooled it
- Pooled it
- Hydroxychloroquine Pre-Exposure Prophylaxis for COVID-19 in Healthcare Workers from India: A Meta-Analysis.Journal of infection and public health · 2021Pooled it
- Efficacy and safety of hydroxychloroquine/chloroquine against SARS-CoV-2 infection: A systematic review and meta-analysis.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2021Pooled it
- Prophylaxis against covid-19: living systematic review and network meta-analysis.BMJ (Clinical research ed.) · 2021Pooled it
- Chloroquine or hydroxychloroquine for prevention and treatment of COVID-19.The Cochrane database of systematic reviews · 2021Pooled it
- Cardiac Complications Attributed to Hydroxychloroquine: A Systematic Review of the Literature Pre-COVID-19.Current cardiology reviews · 2021Pooled it
- Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis.PLoS medicine · 2020Pooled it
- Interventions for treatment of COVID-19: A living systematic review with meta-analyses and trial sequential analyses (The LIVING Project).PLoS medicine · 2020Pooled it
- The PRINCIPLE randomised controlled open label platform trial of hydroxychloroquine for treating COVID19 in community based patients at high risk.Scientific reports · 2025Trial
- Evaluation of hydroxychloroquine or chloroquine for the prevention of COVID-19 (COPCOV): A double-blind, randomised, placebo-controlled trial.PLoS medicine · 2024Trial
- Distribution of age, sex, race, and ethnicity in COVID-19 clinical drug trials in the United States: A review.Contemporary clinical trials · 2022Review
- Identification of Suitable Drug Combinations for Treating COVID-19 Using a Novel Machine Learning Approach: The RAIN Method.Life (Basel, Switzerland) · 2022Review
- Safety of Short-Term Treatments with Oral Chloroquine and Hydroxychloroquine in Patients with and without COVID-19: A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Understanding on the possible routes for SARS CoV-2 invasion via ACE2 in the host linked with multiple organs damage.Infection, genetics and evolution : journal of molecular epidemiology and evolutionary genetics in infectious diseases · 2022Review
- Technical procedures and REDCap tools for internet-based clinical trials.Contemporary clinical trials · 2022Article
- Article
- Hydroxychloroquine: a comprehensive review and its controversial role in coronavirus disease 2019.Annals of medicine · 2021Review
- Kidney injury in COVID-19 patients, drug development and their renal complications: Review study.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2021Review
- The COVID-19 Menace.Global challenges (Hoboken, NJ) · 2021Review
Corrections and comments
- Update of
Authors and funding
27 authors at 8 institutions in 2 countries.
Funding
Abstract
backgroundUse 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.
methodsWe 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.
resultsWe 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.
conclusionsData 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.