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Assessing the efficacy and safety of hydroxychloroquine as outpatient treatment of COVID-19: a randomized controlled trial.
Schwartz, Ilan; Boesen, Mari E; Cerchiaro, Graziela; Doram, Craig; Edwards, Brett D; Ganesh, Aravind; Greenfield, Jamie; Jamieson, Scott; Karnik, Vikram; Kenney, Carol; Lim, Rachel; Menon, Bijoy K; Mponponsuo, Kwadwo; Rathwell, Sarah; Ryckborst, Karla J; Stewart, Breanne; Yaskina, Maryna; Metz, Luanne; Richer, Lawrence; Hill, Michael D.
  • Schwartz I; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Boesen ME; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Cerchiaro G; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Doram C; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Edwards BD; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Ganesh A; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Greenfield J; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Jamieson S; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Karnik V; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Kenney C; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Lim R; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Menon BK; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Mponponsuo K; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Rathwell S; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Ryckborst KJ; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Stewart B; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Yaskina M; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Metz L; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Richer L; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
  • Hill MD; Division of Infectious Diseases (Schwartz, Mponponsuo), Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alta.; Alberta Strategy for Patient Oriented Research SUPPORT Unit (Boesen); Cumming School of Medicine (Boesen, Cerchiaro, Greenfield, Kenney, Ryckbors
CMAJ Open ; 9(2): E693-E702, 2021.
Article in English | MEDLINE | ID: covidwho-1278708
Semantic information from SemMedBD (by NLM)
1. Therapeutic procedure PREVENTS COVID-19
Subject
Therapeutic procedure
Predicate
PREVENTS
Object
COVID-19
2. Mechanical ventilation TREATS COVID-19
Subject
Mechanical ventilation
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TREATS
Object
COVID-19
3. COVID-19 PROCESS_OF Outpatients
Subject
COVID-19
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PROCESS_OF
Object
Outpatients
4. Mechanical ventilation TREATS Outpatients
Subject
Mechanical ventilation
Predicate
TREATS
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Outpatients
5. COVID-19 PROCESS_OF Persons
Subject
COVID-19
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PROCESS_OF
Object
Persons
6. hydroxychloroquine NEG_INHIBITS Duration
Subject
hydroxychloroquine
Predicate
NEG_INHIBITS
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Duration
7. hydroxychloroquine TREATS COVID-19
Subject
hydroxychloroquine
Predicate
TREATS
Object
COVID-19
8. COVID-19 PROCESS_OF hospitalized patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
hospitalized patients
9. hydroxychloroquine TREATS hospitalized patients
Subject
hydroxychloroquine
Predicate
TREATS
Object
hospitalized patients
10. Therapeutic procedure PREVENTS COVID-19
Subject
Therapeutic procedure
Predicate
PREVENTS
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COVID-19
11. Mechanical ventilation TREATS COVID-19
Subject
Mechanical ventilation
Predicate
TREATS
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COVID-19
12. COVID-19 PROCESS_OF Outpatients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Outpatients
13. Mechanical ventilation TREATS Outpatients
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Mechanical ventilation
Predicate
TREATS
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14. COVID-19 PROCESS_OF Persons
Subject
COVID-19
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PROCESS_OF
Object
Persons
15. hydroxychloroquine NEG_INHIBITS Duration
Subject
hydroxychloroquine
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NEG_INHIBITS
Object
Duration
16. hydroxychloroquine TREATS COVID-19
Subject
hydroxychloroquine
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TREATS
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COVID-19
17. COVID-19 PROCESS_OF hospitalized patients
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COVID-19
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PROCESS_OF
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hospitalized patients
18. hydroxychloroquine TREATS hospitalized patients
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hydroxychloroquine
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ABSTRACT

BACKGROUND:

Identification of therapies to prevent severe COVID-19 remains a priority. We sought to determine whether hydroxychloroquine treatment for outpatients with SARS-CoV-2 infection could prevent hospitalization, mechanical ventilation or death.

METHODS:

This randomized controlled trial was conducted in Alberta during the first wave of the COVID-19 pandemic without direct contact with participants. Community-dwelling individuals with confirmed SARS-CoV-2 infection (by reverse transcription polymerase chain reaction [RT-PCR] viral ribonucleic acid test) within the previous 4 days, and symptom onset within the previous 12 days, were randomly assigned to oral hydroxychloroquine or matching placebo for 5 days. Enrolment began Apr. 15, 2020. The primary outcome was the composite of hospitalization, invasive mechanical ventilation or death within 30 days. Secondary outcomes included symptom duration and disposition at 30 days. Safety outcomes, such as serious adverse events and mortality, were also ascertained. Outcomes were determined by telephone follow-up and administrative data.

RESULTS:

Among 4919 individuals with a positive RT-PCR test, 148 (10.2% of a planned 1446 patients) were randomly assigned, 111 to hydroxychloroquine and 37 to placebo. Of the 148 participants, 24 (16.2%) did not start the study drug. Four participants in the hydroxychloroquine group met the primary outcome (4 hospitalizations, 0 mechanical ventilation, 4 survived to 30 days) and none in the placebo group. Hydroxychloroquine did not reduce symptom duration (hazard ratio 0.77, 95% confidence interval 0.49-1.21). Recruitment was paused on May 22, 2020, when a since-retracted publication raised concerns about the safety of hydroxychloroquine for hospitalized patients with COVID-19. Although we had not identified concerns in a safety review, enrolment was slower than expected among those eligible for the study, and cases within the community were decreasing. Recruitment goals were deemed to be unattainable and the trial was not resumed, resulting in a study underpowered to assess the effect of treatment with hydroxychloroquine and safety.

INTERPRETATION:

There was no evidence that hydroxychloroquine reduced symptom duration or prevented severe outcomes among outpatients with proven COVID-19, but the early termination of our study meant that it was underpowered. TRIAL REGISTRATION ClinicalTrials.gov, no. NCT04329611.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Respiration, Artificial / Ambulatory Care / COVID-19 / Hospitalization / Hydroxychloroquine Subject: Respiration, Artificial / Ambulatory Care / COVID-19 / Hospitalization / Hydroxychloroquine Type of study: Controlled clinical trial / Diagnostic study / Prognostic study Language: English Journal: CMAJ Open Clinical aspect: Prognosis / Therapy Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Respiration, Artificial / Ambulatory Care / COVID-19 / Hospitalization / Hydroxychloroquine Subject: Respiration, Artificial / Ambulatory Care / COVID-19 / Hospitalization / Hydroxychloroquine Type of study: Controlled clinical trial / Diagnostic study / Prognostic study Language: English Journal: CMAJ Open Clinical aspect: Prognosis / Therapy Year: 2021
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