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0 0.5 1 1.5 2+ Case 5% Improvement Relative Risk c19hcq.org Abella et al. HCQ for COVID-19 RCT PrEP Favors HCQ Favors control
Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers
Abella et al., JAMA Internal Medicine, doi:doi:10.1001/jamainternmed.2020.6319
Abella et al., Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care.., JAMA Internal Medicine, doi:doi:10.1001/jamainternmed.2020.6319
Sep 2020   Source   PDF  
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Very small early-terminated underpowered PrEP RCT with 64/61 HCQ/control patients and only 8 infections, HCQ infection rate 6.3% versus control 6.6%, RR 0.95 [0.25 - 3.64].
There was no hospitalization or death, no significant difference in QTc, no severe adverse events, no cardiac events (e.g., syncope and arrhythmias) observed. Medication adherence was 81%. Therapeutic levels of HCQ may not have been reached by the time of the infection in the first week.
2 infections were reported to be after discontinuation of the medication, but the authors do not specify which arm these were in. Hypothetically, if these were both in the HCQ arm, the resulting RR for treatment would be much lower.
risk of case, 5.0% lower, RR 0.95, p = 1.00, treatment 4 of 64 (6.2%), control 4 of 61 (6.6%), NNT 325.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Abella et al., 30 Sep 2020, Randomized Controlled Trial, USA, peer-reviewed, 18 authors.
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Abstract: Research JAMA Internal Medicine | Original Investigation Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers A Randomized Clinical Trial Benjamin S. Abella, MD, MPhil; Eliana L. Jolkovsky, BA; Barbara T. Biney, MPH; Julie E. Uspal, MD; Matthew C. Hyman, MD, PhD; Ian Frank, MD; Scott E. Hensley, PhD; Saar Gill, MD, PhD; Dan T. Vogl, MD, MSCE; Ivan Maillard, MD, PhD; Daria V. Babushok, MD; Alexander C. Huang, MD, PhD; Sunita D. Nasta, MD; Jennifer C. Walsh; E. Paul Wiletyo, PhD; Phyllis A. Gimotty, PhD; Michael C. Milone, MD, PhD; Ravi K. Amaravadi, MD; and the Prevention and Treatment of COVID-19 With Hydroxychloroquine (PATCH) Investigators Visual Abstract IMPORTANCE Health care workers (HCWs) caring for patients with coronavirus disease 2019 Supplemental content (COVID-19) are at risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, to our knowledge, there is no effective pharmacologic prophylaxis for individuals at risk. OBJECTIVE To evaluate the efficacy of hydroxychloroquine to prevent transmission of SARS-CoV-2 in hospital-based HCWs with exposure to patients with COVID-19 using a pre-exposure prophylaxis strategy. DESIGN, SETTING, AND PARTICIPANTS This randomized, double-blind, placebo-controlled clinical trial (the Prevention and Treatment of COVID-19 With Hydroxychloroquine Study) was conducted at 2 tertiary urban hospitals, with enrollment from April 9, 2020, to July 14, 2020; follow-up ended August 4, 2020. The trial randomized 132 full-time, hospital-based HCWs (physicians, nurses, certified nursing assistants, emergency technicians, and respiratory therapists), of whom 125 were initially asymptomatic and had negative results for SARS-CoV-2 by nasopharyngeal swab. The trial was terminated early for futility before reaching a planned enrollment of 200 participants. INTERVENTIONS Hydroxychloroquine, 600 mg, daily, or size-matched placebo taken orally for 8 weeks. MAIN OUTCOMES AND MEASURES The primary outcome was the incidence of SARS-CoV-2 infection as determined by a nasopharyngeal swab during the 8 weeks of treatment. Secondary outcomes included adverse effects, treatment discontinuation, presence of SARS-CoV-2 antibodies, frequency of QTc prolongation, and clinical outcomes for SARS-CoV-2–positive participants. RESULTS Of the 132 randomized participants (median age, 33 years [range, 20-66 years]; 91 women [69%]), 125 (94.7%) were evaluable for the primary outcome. There was no significant difference in infection rates in participants randomized to receive hydroxychloroquine compared with placebo (4 of 64 [6.3%] vs 4 of 61 [6.6%]; P > .99). Mild adverse events were more common in participants taking hydroxychloroquine compared with placebo (45% vs 26%; P = .04); rates of treatment discontinuation were similar in both arms (19% vs 16%; P = .81). The median change in QTc (baseline to 4-week evaluation) did not differ between arms (hydroxychloroquine: 4 milliseconds; 95% CI, −9 to 17; vs placebo: 3 milliseconds; 95% CI, −5 to 11; P = .98). Of the 8 participants with positive results for SARS-CoV-2 (6.4%), 6 developed viral symptoms; none required hospitalization, and all clinically recovered. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, although limited by early termination, there was no clinical benefit of hydroxychloroquine administered daily for 8 weeks as pre-exposure prophylaxis in hospital-based..
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