Your browser doesn't support javascript.
Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
Lofgren, Sarah M; Nicol, Melanie R; Bangdiwala, Ananta S; Pastick, Katelyn A; Okafor, Elizabeth C; Skipper, Caleb P; Pullen, Matthew F; Engen, Nicole W; Abassi, Mahsa; Williams, Darlisha A; Nascene, Alanna A; Axelrod, Margaret L; Lother, Sylvain A; MacKenzie, Lauren J; Drobot, Glen; Marten, Nicole; Cheng, Matthew P; Zarychanski, Ryan; Schwartz, Ilan S; Silverman, Michael; Chagla, Zain; Kelly, Lauren E; McDonald, Emily G; Lee, Todd C; Hullsiek, Kathy H; Boulware, David R; Rajasingham, Radha.
  • Lofgren SM; University of Minnesota, Minneapolis, Minnesota, USA.
  • Nicol MR; University of Minnesota, Minneapolis, Minnesota, USA.
  • Bangdiwala AS; University of Minnesota, Minneapolis, Minnesota, USA.
  • Pastick KA; University of Minnesota, Minneapolis, Minnesota, USA.
  • Okafor EC; University of Minnesota, Minneapolis, Minnesota, USA.
  • Skipper CP; University of Minnesota, Minneapolis, Minnesota, USA.
  • Pullen MF; University of Minnesota, Minneapolis, Minnesota, USA.
  • Engen NW; University of Minnesota, Minneapolis, Minnesota, USA.
  • Abassi M; University of Minnesota, Minneapolis, Minnesota, USA.
  • Williams DA; University of Minnesota, Minneapolis, Minnesota, USA.
  • Nascene AA; University of Minnesota, Minneapolis, Minnesota, USA.
  • Axelrod ML; Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Lother SA; Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
  • MacKenzie LJ; Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
  • Drobot G; Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
  • Marten N; George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.
  • Cheng MP; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
  • Zarychanski R; Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.
  • Schwartz IS; Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
  • Silverman M; George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.
  • Chagla Z; Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
  • Kelly LE; Lawson Research Institute, St. Joseph's Healthcare Center, London, Ontario.
  • McDonald EG; McMaster University, Hamilton, Ontario, Canada.
  • Lee TC; George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.
  • Hullsiek KH; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
  • Boulware DR; Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.
  • Rajasingham R; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
Open Forum Infect Dis ; 7(11): ofaa500, 2020 Nov.
Article in English | MEDLINE | ID: covidwho-873054
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
Semantic information from SemMedBD (by NLM)
1. hydroxychloroquine TREATS COVID-19
Subject
hydroxychloroquine
Predicate
TREATS
Object
COVID-19
2. hydroxychloroquine TREATS hospitalized patients
Subject
hydroxychloroquine
Predicate
TREATS
Object
hospitalized patients
3. COVID-19 PROCESS_OF hospitalized patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
hospitalized patients
4. Post-Exposure Prophylaxis TREATS COVID-19
Subject
Post-Exposure Prophylaxis
Predicate
TREATS
Object
COVID-19
5. hydroxychloroquine compared_with Placebos
Subject
hydroxychloroquine
Predicate
compared_with
Object
Placebos
6. Clinical Trials USES Pre-Exposure Prophylaxis
Subject
Clinical Trials
Predicate
USES
Object
Pre-Exposure Prophylaxis
7. hydroxychloroquine TREATS COVID-19
Subject
hydroxychloroquine
Predicate
TREATS
Object
COVID-19
8. hydroxychloroquine TREATS hospitalized patients
Subject
hydroxychloroquine
Predicate
TREATS
Object
hospitalized patients
9. COVID-19 PROCESS_OF hospitalized patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
hospitalized patients
10. Post-Exposure Prophylaxis TREATS COVID-19
Subject
Post-Exposure Prophylaxis
Predicate
TREATS
Object
COVID-19
11. hydroxychloroquine compared_with Placebos
Subject
hydroxychloroquine
Predicate
compared_with
Object
Placebos
12. Clinical Trials USES Pre-Exposure Prophylaxis
Subject
Clinical Trials
Predicate
USES
Object
Pre-Exposure Prophylaxis
ABSTRACT

BACKGROUND:

Use of hydroxychloroquine in hospitalized patients with coronavirus disease 2019 (COVID-19), especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from 3 outpatient randomized clinical trials.

METHODS:

We conducted 3 randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, postexposure prophylaxis, and early treatment for COVID-19 using an internet-based design. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings.

RESULTS:

We enrolled 2795 participants. The median age of research participants (interquartile range) was 40 (34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2544 (91%) participants reported side effect data, and 748 (29%) reported at least 1 medication side effect. Side effects were reported in 40% with once-daily, 36% with twice-weekly, 31% with once-weekly hydroxychloroquine, compared with 19% with placebo. The most common side effects were upset stomach or nausea (25% with once-daily, 19% with twice-weekly, and 18% with once-weekly hydroxychloroquine, vs 11% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for once-daily, 17% twice-weekly, and 13% once-weekly hydroxychloroquine, vs 7% for placebo). Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly hydroxychloroquine. No sudden deaths occurred.

CONCLUSIONS:

Data from 3 outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials, in cohorts of healthy outpatients, can safely investigate whether hydroxychloroquine is efficacious for COVID-19. CLINICALTRIALSGOV IDENTIFIER NCT04308668 for postexposure prophylaxis and early treatment trials; NCT04328467 for pre-exposure prophylaxis trial.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Controlled clinical trial / Prognostic study / Randomized controlled trials Language: English Journal: Open Forum Infect Dis Year: 2020 Document Type: Article Affiliation country: Ofid

Full text: Available Collection: International databases Database: MEDLINE Type of study: Controlled clinical trial / Prognostic study / Randomized controlled trials Language: English Journal: Open Forum Infect Dis Year: 2020 Document Type: Article Affiliation country: Ofid