Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)

Phase 1

• Conditions: Profliaxis of SARS-CoV-2 infection; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001441-39-IT
• Lead Sponsor: IVERSITY OF OXFORD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

•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
•Adults (exact age is dependent on countries)
•Not previously diagnosed with COVID-19
•Not currently symptomatic with an ARI
•Participant A. works in healthcare facility or other well characterised high-risk environment, OR B. is an inpatient or relative of a patient in a participating hospital and likely exposed to COVID-19 infection or another high-risk group
•Possesses an internet-enabled smartphone (Android or iOS)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500

Exclusion Criteria

•Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines
•Contraindication to taking chloroquine 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, which cannot be safely stopped
•Known retinal disease
•Inability to be followed up for the trial period
•Known prolonged QT syndrome (however ECG is not required at baseline)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified