Hydroxychloroquine for prophylaxis of COVID-19 in health workers: A randomized clinical trial
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Abstract
Health care workers are at high risk of being infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Our aim is to evaluate the efficacy and safety of hydroxychloroquine (HCQ) for prophylaxis of coronavirus disease 19 (COVID-19) in health personnel exposed to patients infected by SARS-CoV-2.
Methods
Double-blind randomized, placebo-controlled single center clinical trial. Included subjects were health care workers caring for severe COVID-19 patients. Main outcome was time to symptomatic SARS-CoV-2 infection.
Results
127 subjects with a confirmed baseline negative RT-PCR SARS-CoV2 test were included in the trial. 62 assigned to HCQ and 65 to placebo. One subject (1.6%) in the HCQ group and 6 (9.2%) subjects in the placebo group developed COVID-19 (Log-Rank test p = 0.07). No severe COVID-19 cases were observed. The study was suspended because of a refusal to participate and losses to follow up after several trials reported lack of effectiveness of hydroxychloroquine in hospitalized patients with COVID-19.
Conclusion
The effect size of hydroxychloroquine was higher than placebo for COVID-19 symptomatic infection in health personnel, although this was not statistically significant. The trial is underpowered due to the failure to complete the estimated sample size.
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SciScore for 10.1101/2021.05.14.21257059: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Written informed consent was obtained from all participants before study entry. Sex as a biological variable All women in reproductive age not using a permanent contraceptive method were asked to perform a urine pregnancy test (CERTUM diagnostics, Kabla diagnosticos, Mexico). Randomization Trial design: This was a double-blind, randomized, head to head placebo-controlled clinical trial, held at the National Institute of Respiratory Diseases (INER) of Mexico, a public national referral center for respiratory diseases and a main teaching center and research facility for respiratory diseases. Blinding Recruiters, trial team and the evaluators of follow up condition were blinded to group … SciScore for 10.1101/2021.05.14.21257059: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Written informed consent was obtained from all participants before study entry. Sex as a biological variable All women in reproductive age not using a permanent contraceptive method were asked to perform a urine pregnancy test (CERTUM diagnostics, Kabla diagnosticos, Mexico). Randomization Trial design: This was a double-blind, randomized, head to head placebo-controlled clinical trial, held at the National Institute of Respiratory Diseases (INER) of Mexico, a public national referral center for respiratory diseases and a main teaching center and research facility for respiratory diseases. Blinding Recruiters, trial team and the evaluators of follow up condition were blinded to group assignment. Power Analysis Sample size: Th sample size calculation was estimated according the primary objective of the study, the time to a symptomatic SARS-CoV2 infection, assuming a 20% rate of infection in control group, as reported from Italy in February3, vs a 10% in the experimental group (10% reduction). Table 2: Resources
Antibodies Sentences Resources Assay results were interpreted as follows: cutoff index, <1.0 for samples that were nonreactive/negative for anti-SARS-CoV-2 antibodies; cutoff index, ≥1.0 for samples that were reactive/positive for anti-SARS-CoV-2 antibodies. anti-SARS-CoV-2suggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04318015 Recruiting Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel … Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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