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10.1001/jamainternmed.2020.6319

http://scihub22266oqcxt.onion/10.1001/jamainternmed.2020.6319
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33001138!7527945!33001138
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suck abstract from ncbi


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pmid33001138      JAMA+Intern+Med 2021 ; 181 (2): 195-202
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  • Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers: A Randomized Clinical Trial #MMPMID33001138
  • Abella BS; Jolkovsky EL; Biney BT; Uspal JE; Hyman MC; Frank I; Hensley SE; Gill S; Vogl DT; Maillard I; Babushok DV; Huang AC; Nasta SD; Walsh JC; Wiletyo EP; Gimotty PA; Milone MC; Amaravadi RK
  • JAMA Intern Med 2021[Feb]; 181 (2): 195-202 PMID33001138show ga
  • IMPORTANCE: Health care workers (HCWs) caring for patients with coronavirus disease 2019 (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 HCWs exposed to patients with COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04329923.
  • |*COVID-19 Drug Treatment[MESH]
  • |*Personnel, Hospital[MESH]
  • |*Pre-Exposure Prophylaxis[MESH]
  • |Adult[MESH]
  • |COVID-19/epidemiology/*prevention & control[MESH]
  • |Cross Infection/*prevention & control/*virology[MESH]
  • |Double-Blind Method[MESH]
  • |Female[MESH]
  • |Hospitals, Urban[MESH]
  • |Humans[MESH]
  • |Hydroxychloroquine/*administration & dosage[MESH]
  • |Incidence[MESH]
  • |Male[MESH]
  • |Pennsylvania/epidemiology[MESH]


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