COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=11019

Anthony Etyang

AEtyang@kemri-wellcome.org

2020-05-07

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

• 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)

2

Dr. William Schilling

18

65

Kenya

Healthy volunteers

N/A

1600

The number of symptomatic COVID-19 infections will be compared between participants randomised to hydroxychloroquine; and placebo groups

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]