Does taking hydroxychloroquine before and during exposure to patients protect frontline healthcare workers from coronavirus?

Phase 3

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN14326006
• Lead Sponsor: niversity Health Network

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32665039/ structured summary of protocol (added 17/07/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Study Completion: 2022-02-28
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.