Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)
Overview
- Phase
- Not Applicable
- Intervention
- Chloroquine or Hydroxychloroquine
- Conditions
- COVID19
- Sponsor
- University of Oxford
- Enrollment
- 4652
- Locations
- 25
- Primary Endpoint
- Number of symptomatic COVID-19 infections
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites.
The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months.
If the participant is diagnosed with COVID-19, they will take continue to take the study medication until:
- 90 days after enrolment (i.e., completion of kit)
- hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or
- advised to stop by their healthcare professional for other reasons
Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.
This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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, or history of these medications within the previous 7 days
- •Taking prohibited medications
- •Known retinal disease
- •Inability to be followed up for the trial period
- •Known prolonged QT syndrome (however ECG is not required at baseline)
- •Known pregnancy or women who are actively trying to become pregnant
- •Prior diagnosis of porphyria
- •Previously received any dose of COVID-19 vaccine
Arms & Interventions
Chloroquine or Hydroxychloroquine
In Asia, the participant will receive chloroquine. In Europe, the participant will receive hydroxychloroquine Specific drug allocation will be determined by country prior to activation based upon factors such as inventory availability and importation requirements
Intervention: Chloroquine or Hydroxychloroquine
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of symptomatic COVID-19 infections
Time Frame: Approximately 90 days
Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups
Secondary Outcomes
- Number of symptomatic acute respiratory illnesses(Approximately 90 days)
- Symptoms severity of COVID-19(Approximately 90 days)
- Number of asymptomatic cases of COVID-19(Approximately 90 days)
- Severity of symptomatic acute respiratory illnesses(Approximately 90 days)