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Hydroxychloroquine for prophylaxis of COVID-19 in health workers: A randomized clinical trial

Rojas-Serrano et al., PLOS ONE, doi:10.1371/journal.pone.0261980 (date from preprint), NCT04318015
May 2021  
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Symp. case 82% Improvement Relative Risk HCQ  Rojas-Serrano et al.  Prophylaxis  DB RCT Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? Double-blind RCT 127 patients in Mexico (April 2020 - March 2021) Fewer symptomatic cases with HCQ (not stat. sig., p=0.12) c19hcq.org Rojas-Serrano et al., PLOS ONE, May 2021 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 419 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19hcq.org
Early terminated HCQ PrEP RCT with 62 HCQ and 65 placebo patients, showing 82% lower cases with treatment, p = 0.12. 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.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Rojas-Serrano et al., 16 May 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Mexico, peer-reviewed, median age 31.5, 8 authors, study period 14 April, 2020 - 31 March, 2021, trial NCT04318015 (history). Contact: jrojas@iner.gob.mx.
This PaperHCQAll
Hydroxychloroquine For Prophylaxis Of COVID-19 In Health Workers: A Randomized Clinical Trial
Jorge Rojas-Serrano, Angelica Margarita Portillo-Vásquez Thirion-Romero, Joel Vázquez-Pérez, Fidencio Mejía-Nepomuceno Alejandra Ramírez-Venegas, Karla Midori Pérez-Kawabe, Rogelio Pérez-Padilla
doi:10.1101/2021.05.14.21257059
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.
Hydroxychloroquine For Prophylaxis Of COVID-19 In Health 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 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,
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