COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Intervention: Hydroxychloroquine 400 mg orally once a day as pre-exposure prophylaxis against COVID-19.
Control: Placebo.
Randomization details: Fixed 1:1 allocation ratio produced by a computer-based
Sponsors
University Health Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Health care worker (HCW) in the emergency department who is anticipated to work at least 10 shifts over the duration of the study period (minimum 6 hours per shift) and anticipated to remain in the emergency department for the duration of the study (i.e., not transferring to another unit). For the purposes of the study, “health care workers” are physicians (including residents), nurses, nurse practitioners, physician assistants, respiratory therapists, X-ray technicians, social workers and support staff (including but not limited to house-keeping, and porters) 2. Age =18 years 3. Ability to communicate with study staff in English
Exclusion criteria
Exclusion criteria: 1. Currently pregnant, planning to become pregnant during the study period, and/or breast feeding 2. Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds. 3. Current use of hydroxychloroquine for the treatment of a medical condition. 4. Known prolonged QT syndrome, or concomitant medications which simultaneously may prolong the QTC that cannot be temporarily suspended/replaced. These are including but not limited to Class IA, IC and III antiarrhythmics; certain antidepressants, antipsychotics, and anti-infectives; domperidone; 5-hydroxytryptamine (5-HT)3 receptor antagonists; kinase inhibitors; histone deacetylase inhibitors beta-2 adrenoceptor agonists. 5. Known pre-existing retinopathy. 6. Disclosure of self-administered use of hydroxychloroquine or chloroquine within 12 weeks prior to study. This window allows five half-lives of HCQ (i.e. 21 days) to pass before being reintroduced to the drug. 7. Confirmed symptomatic COVID-19 at time of enrollment, i.e. symptom of COVID-19 at enrollment with confirmation of SARS-CoV-2 infection by viral detection as performed according to local guidelines for symptomatic HCWs. All participants with COVID-19 symptoms at enrollment will be directed to have confirmatory testing (within the department or occupational health as per the site guidelines). Participants who are negative for SARS-CoV-2 will be redirected to enrollment procedures; those testing positive will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbiologically confirmed COVID-19 (i.e. SARS-CoV-2 infection). This is a composite endpoint which includes any validated SARS-CoV-2 diagnostic assay, including detection of viral RNA and seroconversion, performed on participant viral detection samples throughout the study period or venous samples for serologic testing collected at day 0, 30, 60, 90 and 120. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events assessed using the DAIDS Table for Grading the Severity of Adverse Events, at day 30, 60, 90, and day 120 2. Symptom duration of COVID-19, measured in days, collected from participants via self-report (questionnaire) weekly (every 7 days) from day 7 to 120 3. Days of hospitalization attributable to COVID-19: the number of days (or partial days) spent admitted to an acute care hospital during the study period. Collected from participants or designate via self-report (questionnaire) weekly (every 7 days) from day 7 to 120 4. Respiratory failure requiring ventilatory support attributable to COVID-19: the number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation during the study period. Collected from participants or designate via self-report (questionnaire) weekly (every 7 days) from day 7 to 120 5. Mortality attributable to COVID-19 and all-cause mortality during the study period, collected from participants or designate via self-report (questionnaire) weekly (every 7 days) from day 7 to 120 6. Number of days ineligible/unable to work due to COVID-19, measured from symptom onset to return to work date, collected from participants or designate via self-report (questionnaire) weekly (every 7 days) from day 7 to 120 7. Seropositivity: reactive serology by day 120, blood collected at day 0, 30, 60, 90, 120 8. Short-term psychological impact of exposure to COVID-19 measured using the K10, a validated measure of non-specific psychological distress, with a standard cutoff score of =16, at the beginning of randomization (day 1), during the randomized period (day 60) and during the open-label period (day 120) Note: In the case of death or other conditions rendering the participant unable to communicate or complete the weekly email survey, the outcome will be obtained by contacting the designate identified by the participant at enrolment. If it is not possible to reach this person, the participant will be con | — |
Countries
Canada
Contacts
Public ContactJulie Wright
Outcome results
None listed