Chloroquine/ hydroxychloroquine prevention of COVID-19 (COPCOV)

Phase 1

• Conditions: COVID-19, acute respiratory illness; 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-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-29
• Last Update Posted: 25 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1.Participant is willing and able to give informed consent for participation in the study
2.Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals
3.Adults (exact age is dependent on countries) less than 70 years old at the time of consent). See Appendix F for UK specific information
4.Not previously diagnosed with COVID-19
5.Not currently symptomatic with an ARI
6.Participant works in a facility where there are cases of either proven or suspected COVID-19
7.Possesses an internet-enabled smartphone (Android or iOS)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

1. Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines
2. Contraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance < 10 ml/min
3. Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines
4. Taking a concomitant medication described in section 8.5
5. Known retinal disease
6. Inability to be followed up for the trial period
7. Known prolonged QT syndrome (however ECG is not required at baseline)
8. Prior diagnosis of porphyria
9. Known pregnancy or women who are actively trying to become pregnant

Study & Design

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