Your browser doesn't support javascript.
Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers: A Randomized Clinical Trial.
Abella, Benjamin S; Jolkovsky, Eliana L; Biney, Barbara T; Uspal, Julie E; Hyman, Matthew C; Frank, Ian; Hensley, Scott E; Gill, Saar; Vogl, Dan T; Maillard, Ivan; Babushok, Daria V; Huang, Alexander C; Nasta, Sunita D; Walsh, Jennifer C; Wiletyo, E Paul; Gimotty, Phyllis A; Milone, Michael C; Amaravadi, Ravi K.
  • Abella BS; Department of Emergency Medicine, University of Pennsylvania, Philadelphia.
  • Jolkovsky EL; Department of Emergency Medicine, University of Pennsylvania, Philadelphia.
  • Biney BT; Department of Emergency Medicine, University of Pennsylvania, Philadelphia.
  • Uspal JE; Department of Emergency Medicine, University of Pennsylvania, Philadelphia.
  • Hyman MC; Division of Cardiology, Department of Medicine University of Pennsylvania, Philadelphia.
  • Frank I; Division of Infectious Disease, Department of Medicine University of Pennsylvania, Philadelphia.
  • Hensley SE; Department of Microbiology, University of Pennsylvania, Philadelphia.
  • Gill S; Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.
  • Vogl DT; Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.
  • Maillard I; Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.
  • Babushok DV; Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.
  • Huang AC; Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.
  • Nasta SD; Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.
  • Walsh JC; Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.
  • Wiletyo EP; Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia.
  • Gimotty PA; Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia.
  • Milone MC; Department of Pathology, University of Pennsylvania, Philadelphia.
  • Amaravadi RK; Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.
JAMA Intern Med ; 181(2): 195-202, 2021 02 01.
Article in English | MEDLINE | ID: covidwho-1064281
ABSTRACT
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Personnel, Hospital / Cross Infection / Pre-Exposure Prophylaxis / COVID-19 / COVID-19 Drug Treatment / Hydroxychloroquine Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male Country/Region as subject: North America Language: English Journal: JAMA Intern Med Year: 2021 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Personnel, Hospital / Cross Infection / Pre-Exposure Prophylaxis / COVID-19 / COVID-19 Drug Treatment / Hydroxychloroquine Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male Country/Region as subject: North America Language: English Journal: JAMA Intern Med Year: 2021 Document Type: Article