Hydroxychloroquine for prevention of COVID-19
- Conditions
- Coronavirus disease
- Registration Number
- PACTR202009786901147
- Lead Sponsor
- Dr. William Schilling
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1600
•18 years and above
•Participant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct
•Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals (e.g. not on HAART that includes LPV/r as part of the regimen)
•Not previously diagnosed with COVID-19
•Not currently symptomatic with an acute respiratory infection (ARI)
•Possesses an internet-enabled smartphone (Android or iOS) or computer
•Hypersensitivity reaction to hydroxychloroquine or 4-aminoquinolines
•Contraindication to taking hydroxychloroquine as prophylaxis, e.g. known epileptic, known creatinine clearance < 10 ml/min
•Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines
•Taking a concomitant medication described in section 8.5 of the master protocol, which cannot be safely stopped known retinal disease
•Inability to be followed up for the trial period
•Known prolonged QT syndrome (ECG will be required for potential participants who report having a heart condition)
•Is enrolled in another clinical trial (however participants will be allowed to participate in observational studies)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of symptomatic COVID-19 infections will be compared between participants randomised to hydroxychloroquine, and placebo groups
- Secondary Outcome Measures
Name Time Method The symptoms,severity and duration of COVID-19, in those who become infected during the study will be compared between the two groups using a respiratory severity score;The number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up;The number and severity of symptomatic acute respiratory illnesses will be compared between the hydroxychloroquine,and placebo group