Hydroxychloroquine For Prophylaxis Of COVID-19 In Health Workers: A Randomized Clinical Trial
Early terminated HCQ PrEP RCT with 62 HCQ and 65 placebo patients, showing 82% lower cases with treatment,
p = 0.12.
NCT04318015 (history).
If the trial is continued and the same event rate is observed, statistical significance will be reached after adding about 16 patients per arm.
risk of symptomatic case, 82.0% lower, RR 0.18, p = 0.12, treatment 1 of 62 (1.6%), control 6 of 65 (9.2%), NNT 13, adjusted per study.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Rojas-Serrano et al., 16 May 2021, Double Blind Randomized Controlled Trial, Mexico, preprint, 8 authors, trial
NCT04318015 (history).
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2021.05.14.21257059; this version posted May 16, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
Hydroxychloroquine For Prophylaxis Of COVID-19 In Health
Workers: A Randomized Clinical Trial.
AUTHORS: Jorge Rojas-Serrano, Angelica Margarita Portillo-Vásquez Ireri
Thirion-Romero, Joel Vázquez-Pérez, Fidencio Mejía-Nepomuceno Alejandra
Ramírez-Venegas, Karla Midori Pérez-Kawabe, Rogelio Pérez-Padilla.
On behalf of the RESEARCH GROUP ON HYDROXYCHLOROQUINE FOR
COVID-19 also formed by Dr. Cristobal Guadarrama, Dr. Carmen Margarita
Hernández Cárdenas, Dr. Luis Felipe Jurado Camacho Dr. Sebastián Rodríguez
Llamazares, Dra. Alejandra Ramírez Venegas
ACKNOWLEDGMENTS: FUNDING
Support for the trial was received from the Instituto Nacional de Enfermedades
Respiratorias (INER), from CONACYT (national council of science and technology)
and by SANOFI-AVENTIS through an investigator-sponsored trial. Neither the
INER, CONACYT or SANOFI AVENTIS had role in the des ign of the study,
collection of data, analysis, results interpretation, the writing of the final report and
the decision to submit the article to publication.
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2021.05.14.21257059; this version posted May 16, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
SUMMARY
Health care workers are at high risk of being infected with the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV2). Our aim is to evaluate the
efficacy and safety of hydroxychloroquine (HCQ) for prophylaxis of COVID19 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 COVD19 patients.
Main outcome was time to symptomatic SARS-CoV2 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 = 0.09). No severe COVID19 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
Although the number of symptomatic infections in health personnel was lower in
the HCQ group, the difference was not statistically significant. The trial is
underpowered due to the failure to complete the estimated sample size.
Key words: COVID-19, health workers, prophylaxis, hydroxychloroquine,
medRxiv preprint doi: https://doi.org/10.1101/2021.05.14.21257059; this version posted May 16, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without..
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