EUCTR2020-001441-39-GB
Active, not recruiting
Phase 1
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV) - COPCOV trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oxford
- Enrollment
- 10000
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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