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Clinical Trials/EUCTR2020-001441-39-GB
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

niversity of Oxford0 sites10,000 target enrollmentApril 29, 2020

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.

Registry
who.int
Start Date
April 29, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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