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Clinical Trials/EUCTR2020-001441-39-IT
EUCTR2020-001441-39-IT
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 - Study of COVID-19 and Chloroquine/hydroxychloroquine in healthcare setting

IVERSITY OF OXFORD0 sites40,000 target enrollmentJune 24, 2020
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ConditionsProfliaxis of SARS-CoV-2 infectionMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Profliaxis of SARS-CoV-2 infection
Sponsor
IVERSITY OF OXFORD
Enrollment
40000
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 24, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
IVERSITY OF OXFORD

Eligibility Criteria

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

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)

Outcomes

Primary Outcomes

Not specified

Similar Trials

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