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Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial.
Rajasingham, Radha; Bangdiwala, Ananta S; Nicol, Melanie R; Skipper, Caleb P; Pastick, Katelyn A; Axelrod, Margaret L; Pullen, Matthew F; Nascene, Alanna A; Williams, Darlisha A; Engen, Nicole W; Okafor, Elizabeth C; Rini, Brian I; Mayer, Ingrid A; McDonald, Emily G; Lee, Todd C; Li, Peter; MacKenzie, Lauren J; Balko, Justin M; Dunlop, Stephen J; Hullsiek, Katherine H; Boulware, David R; Lofgren, Sarah M.
  • Rajasingham R; University of Minnesota, Minneapolis, Minnesota, USA.
  • Bangdiwala AS; University of Minnesota, Minneapolis, Minnesota, USA.
  • Nicol MR; University of Minnesota, Minneapolis, Minnesota, USA.
  • Skipper CP; University of Minnesota, Minneapolis, Minnesota, USA.
  • Pastick KA; University of Minnesota, Minneapolis, Minnesota, USA.
  • Axelrod ML; Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Pullen MF; University of Minnesota, Minneapolis, Minnesota, USA.
  • Nascene AA; University of Minnesota, Minneapolis, Minnesota, USA.
  • Williams DA; University of Minnesota, Minneapolis, Minnesota, USA.
  • Engen NW; University of Minnesota, Minneapolis, Minnesota, USA.
  • Okafor EC; University of Minnesota, Minneapolis, Minnesota, USA.
  • Rini BI; Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Mayer IA; Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • McDonald EG; Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.
  • Lee TC; Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.
  • Li P; Oregon Health and Science University, Portland, Oregon, USA.
  • MacKenzie LJ; Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
  • Balko JM; Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Dunlop SJ; University of Minnesota, Minneapolis, Minnesota, USA.
  • Hullsiek KH; Hennepin Healthcare, Minneapolis, Minnesota, USA.
  • Boulware DR; University of Minnesota, Minneapolis, Minnesota, USA.
  • Lofgren SM; University of Minnesota, Minneapolis, Minnesota, USA.
Clin Infect Dis ; 72(11): e835-e843, 2021 06 01.
Article in English | MEDLINE | ID: covidwho-1249296
Semantic information from SemMedBD (by NLM)
1. Pre-Exposure Prophylaxis TREATS COVID-19
Subject
Pre-Exposure Prophylaxis
Predicate
TREATS
Object
COVID-19
2. COVID-19 PROCESS_OF Health Personnel
Subject
COVID-19
Predicate
PROCESS_OF
Object
Health Personnel
3. Virus CAUSES COVID-19
Subject
Virus
Predicate
CAUSES
Object
COVID-19
4. hydroxychloroquine PREVENTS 2019 novel coronavirus
Subject
hydroxychloroquine
Predicate
PREVENTS
Object
2019 novel coronavirus
5. 2019 novel coronavirus PROCESS_OF Health Personnel
Subject
2019 novel coronavirus
Predicate
PROCESS_OF
Object
Health Personnel
6. Controlled Clinical Trial USES C0032042
Subject
Controlled Clinical Trial
Predicate
USES
Object
C0032042
7. Accident and Emergency department LOCATION_OF Work
Subject
Accident and Emergency department
Predicate
LOCATION_OF
Object
Work
8. 2019 novel coronavirus PROCESS_OF Persons
Subject
2019 novel coronavirus
Predicate
PROCESS_OF
Object
Persons
9. hydroxychloroquine compared_with Placebos
Subject
hydroxychloroquine
Predicate
compared_with
Object
Placebos
10. peripheral blood LOCATION_OF hydroxychloroquine
Subject
peripheral blood
Predicate
LOCATION_OF
Object
hydroxychloroquine
11. Pre-Exposure Prophylaxis USES hydroxychloroquine
Subject
Pre-Exposure Prophylaxis
Predicate
USES
Object
hydroxychloroquine
12. Pre-Exposure Prophylaxis PREVENTS COVID-19
Subject
Pre-Exposure Prophylaxis
Predicate
PREVENTS
Object
COVID-19
13. Pre-Exposure Prophylaxis TREATS COVID-19
Subject
Pre-Exposure Prophylaxis
Predicate
TREATS
Object
COVID-19
14. COVID-19 PROCESS_OF Health Personnel
Subject
COVID-19
Predicate
PROCESS_OF
Object
Health Personnel
15. Virus CAUSES COVID-19
Subject
Virus
Predicate
CAUSES
Object
COVID-19
16. hydroxychloroquine PREVENTS 2019 novel coronavirus
Subject
hydroxychloroquine
Predicate
PREVENTS
Object
2019 novel coronavirus
17. 2019 novel coronavirus PROCESS_OF Health Personnel
Subject
2019 novel coronavirus
Predicate
PROCESS_OF
Object
Health Personnel
18. Controlled Clinical Trials, Randomized USES Placebos
Subject
Controlled Clinical Trials, Randomized
Predicate
USES
Object
Placebos
19. Accident and Emergency department LOCATION_OF Work
Subject
Accident and Emergency department
Predicate
LOCATION_OF
Object
Work
20. 2019 novel coronavirus PROCESS_OF Persons
Subject
2019 novel coronavirus
Predicate
PROCESS_OF
Object
Persons
21. hydroxychloroquine compared_with Placebos
Subject
hydroxychloroquine
Predicate
compared_with
Object
Placebos
22. peripheral blood LOCATION_OF hydroxychloroquine
Subject
peripheral blood
Predicate
LOCATION_OF
Object
hydroxychloroquine
23. Pre-Exposure Prophylaxis USES hydroxychloroquine
Subject
Pre-Exposure Prophylaxis
Predicate
USES
Object
hydroxychloroquine
24. Pre-Exposure Prophylaxis PREVENTS COVID-19
Subject
Pre-Exposure Prophylaxis
Predicate
PREVENTS
Object
COVID-19
ABSTRACT

BACKGROUND:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing coronavirus disease 2019 (COVID-19) pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure.

METHODS:

We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, COVID-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine loading dose then 400 mg once or twice weekly for 12 weeks. The primary endpoint was confirmed or probable COVID-19-compatible illness. We measured hydroxychloroquine whole-blood concentrations.

RESULTS:

We enrolled 1483 healthcare workers, of whom 79% reported performing aerosol-generating procedures. The incidence of COVID-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events/person-year with once-weekly and 0.28 events/person-year with twice-weekly hydroxychloroquine compared with 0.38 events/person-year with placebo. For once-weekly hydroxychloroquine prophylaxis, the hazard ratio was .72 (95% CI, .44-1.16; P = .18) and for twice-weekly was .74 (95% CI, .46-1.19; P = .22) compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed COVID-19-compatible illness (154 ng/mL) versus participants without COVID-19 (133 ng/mL; P = .08).

CONCLUSIONS:

Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed COVID-19 or COVID-19-compatible illness among healthcare workers. CLINICAL TRIALS REGISTRATION Clinicaltrials.gov NCT04328467.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pre-Exposure Prophylaxis / COVID-19 Type of study: Controlled clinical trial / Randomized controlled trials Limits: Humans Country/Region as subject: North America Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: Cid

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pre-Exposure Prophylaxis / COVID-19 Type of study: Controlled clinical trial / Randomized controlled trials Limits: Humans Country/Region as subject: North America Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: Cid