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Hydroxychloroquine for SARS CoV2 Prophylaxis in Healthcare Workers – A Multicentric Cohort Study Assessing Effectiveness and Safety

Badyal et al., Journal of the Association of Physicians of India, 69:6, June 2021
Jun 2021  
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Case, ≥6 weeks 60% Improvement Relative Risk Case, 4-5 weeks 35% Case, 2-3 weeks 23% HCQ for COVID-19  Badyal et al.  Prophylaxis Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? Prospective study of 2,090 patients in India (May - Sep 2020) Fewer cases with HCQ (p<0.000001) Badyal et al., J. the Association of P.., Jun 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 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments.
Prophylaxis study with 12,089 Indian healthcare workers, showing lower risk of COVID-19 cases with treatment, and increasingly lower risk for longer durations of HCQ prophylaxis. The appendices are not currently available.
risk of case, 60.1% lower, RR 0.40, p < 0.001, treatment 247 of 617 (40.0%), control 611 of 1,473 (41.5%), adjusted per study, odds ratio converted to relative risk, ≥6 weeks.
risk of case, 35.1% lower, RR 0.65, p = 0.003, treatment 88 of 185 (47.6%), control 611 of 1,473 (41.5%), adjusted per study, odds ratio converted to relative risk, 4-5 weeks.
risk of case, 23.2% lower, RR 0.77, p = 0.03, treatment 80 of 181 (44.2%), control 611 of 1,473 (41.5%), adjusted per study, odds ratio converted to relative risk, 2-3 weeks.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Badyal et al., 7 Jun 2021, prospective, India, peer-reviewed, 18 authors, study period May 2020 - September 2020.
This PaperHCQAll
Hydoxychloroquine for SARS CoV2 Prophylaxis in Healthcare Workers -A Multicentric Cohort Study Assessing Effectiveness and Safety
Badyal Dinesh, Chandy Sujith, Chugh Preeta Kaur, Faruqui Atiya, Gupta Yk, Hazra Avijit, Kamat Sandhya, Kamboj Vp, Kaul Rajani, Kshirsagar Nilima, Maulik Subir, Medhi Bikash, Menon Geetha, Ranjalkar Jaya, Rao Vishnu, Shetty Yashashri, Tripathi Raakhi, Xavier Denis, Nimarpreet Kaur, Hatinder Jeet, Singh Sethi, Sharad Bedi, Deepti Dwivedi
n a l a r t i c l e affordable medicines such as HCQ is therefore needed. We report here a large multicenter prospective cohort study on HCWs, comparing HCQ and no HCQ for pre-exposure prophylaxis and the impact of age, gender, comorbidities, and exposure to SARS-CoV-2 cases, on HCQ effectiveness and safety. Methods This prospective, observational, multicenter cohort study in 44 hospitals in 17 states of India included HCW's (doctors, nurses, allied staff) who were either taking or not taking prophylactic treatment for COVID-19 and were likely to be exposed to COVID 19 cases. There were no exclusion criteria. C o n s e n t i n g H C Ws , f i l l e d a n online questionnaire, sent by e-mail or free messaging application, with information and consent.
Ethical approval All the sites obtained approval from their Institutional Ethics Committees to conduct the study. In addition, a p p r o va l f r o m t h e I C M R C e n t r a l Ethics Committee on Human Research (CECHR) was obtained (NCDIR/BEU/ I C M R -C E C H R / 7 5 / 2 0 2 0 / 1 3 t h M a y 2020)]. The study was registered on CTRI site -CTRI/2020/05/025183. Data sharing No additional data is available. All the authors affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have b een omit t ed; and t hat any discrepancies from the study as planned have been explained. Acknowledgement The authors gratefully acknowledge D r . B a l r a m B h a r g a va , S e c r e t a r y , D e p a r t m e n t o f H e a l t h R e s e a r c h , Director General, Indian Council of Medical Research, Govt of India, for his guidance and support in setting up ICMR RUMC and conducting this Author contributions
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Thotakura, Mallayasamy, Kshirsagar, A physiologically based pharmacokinetic modeling (PBPK) approach for evaluation and suggestion for hydroxychloroquine dosage regimens for the prophylaxis of COVID-19, Submitted to Ind J Med Res
White, Watson, Hoglund, COVID-19 prevention and treatment: A critical analysis of chloroquine and hydroxychloroquine clinical pharmacology, PLoS Med, doi:10.1371/journal.pmed.1003252
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