Coronavirus disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of symptomatic COVID-19 infections will be compared between participants randomised to hydroxychloroquine, and placebo groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Kenya
Contacts
Kenya Medical Research Institute CGMRC