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COPCOV: Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT04303507
Collaborator
(none)
4,646
Enrollment
25
Locations
2
Arms
22.7
Actual Duration (Months)
185.8
Patients Per Site
8.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chloroquine or Hydroxychloroquine
  • Drug: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
4646 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)
Actual Study Start Date :
Apr 29, 2020
Actual Primary Completion Date :
Mar 22, 2022
Actual Study Completion Date :
Mar 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Chloroquine or Hydroxychloroquine
A loading dose of 10 mg base/ kg followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months
Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Number of symptomatic COVID-19 infections [Approximately 90 days]

    Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups

Secondary Outcome Measures

  1. Symptoms severity of COVID-19 [Approximately 90 days]

    Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.

  2. Number of asymptomatic cases of COVID-19 [Approximately 90 days]

    Number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up.

  3. Number of symptomatic acute respiratory illnesses [Approximately 90 days]

    Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

  4. Severity of symptomatic acute respiratory illnesses [Approximately 90 days]

    Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

Other Outcome Measures

  1. Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity. [Approximately 90 days]

    Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.

  2. Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic. [Approximately 90 days]

    Number of days lost to work in relation to the treatment arm

  3. Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs [Approximately 90 days]

    The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups.

  4. Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L) [Approximately 90 days]

    The trial will collect data on health-related quality of life using the quality of life questionnaire (EQ-5D-3L) to determine the effects between treatment groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Study Participants The study population is adult healthcare workers and other persons defined by the site investigator at risk of contracting COVID-19.

Inclusion Criteria

  1. Participant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct

  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

  4. Not previously diagnosed with COVID-19

  5. Not currently symptomatic with an ARI

  6. Participant is a healthcare worker or is a person at risk of contracting COVID-19.

  7. Possesses an internet-enabled smartphone (Android or iOS)

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, or history of these medications within the previous 7 days

  4. Taking prohibited medications

  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. Known pregnancy or women who are actively trying to become pregnant

  9. Prior diagnosis of porphyria

  10. Previously received any dose of COVID-19 vaccine

The investigator may consult the physician's guidance documents for any further questions regarding eligibility of potential participants.

Prohibited medications for the purpose of study enrollment include:

  • Antiarrhythmic medications: digoxin, amiodarone, sotalol, flecainide

  • Antiparasitic/malarial agents: mefloquine, halofantrine, praziquantel

  • Antibiotics: levofloxacin, moxifloxacin, ciprofloxacin, azithromycin, clarithromycin, erythromycin

  • Antifungal drugs: fluconazole, ketoconazole, itraconazole, terfenadine

  • Psychoactive drugs: lithium, quetiapine, chlorpromazine, thioridazine, ziprasidone, haloperidol, droperidol, methadone

  • Migraine treatment: sumatriptan

  • Antihistamines: astemizole

  • Antiemetics: prochlorperazine, metoclopramide

  • Cancer treatments: abiraterone, dabrafenib, dacomitinib, enzalutamide, idelalisib, mitotane

  • Other specific drugs: ciclosporin, conivaptan, agalsidase alfa or beta, mifepristone, stiripentol

PrincipaI Investigators will also be directed to crediblemeds.org to check other agents that may prolong QT interval

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier et Universitaire de Zone Abomey-Calavi Abomey-Calavi Benin
2 Hospital De Zone Allada Allada Benin
3 University Hospital Center of Angre Abidjan Côte D'Ivoire BP 54378
4 University Hospital Center of Bouake Bouake Côte D'Ivoire BP 1174
5 Airlangga University Hospital (UNAIR) Surabaya East Java Indonesia 60115
6 Husada Utama Hospital Surabaya East Java Indonesia 60131
7 Bunda Thamrin Hospital Medan North Sumatra Indonesia 20112
8 Murni Teguh Memorial Hospital Medan North Sumatra Indonesia 20231
9 Sardjito Hospital Yogyakarta Indonesia 55281
10 Fountain Healthcare Hospital Eldoret Kenya
11 Mbagathi County Hospital Nairobi Kenya
12 The Bamako Hospital of Dermatology Bamako Mali BP251
13 Hospital Of Mali Bamako Mali BP3333
14 B.P. Koirala Institute of Health Sciences Dharān Bāzār Nepal 56700
15 The Aga Khan University Hospital Karachi Pakistan 74800
16 Faculty of Tropical Medicine, Mahidol University Bangkok Thailand 10400
17 University Hospitals Of Morecambe Bay NHS Foundation Trust Kendal Cumbria United Kingdom LA9 7RG
18 The Dudley Group NHS Foundation Trust Dudley West Midlands United Kingdom DY1 2HQ
19 Birmingham & Solihull Mental Health NHS Trust Birmingham United Kingdom B1 3RB
20 Brighton and Sussex University Hospitals NHS Trust Brighton United Kingdom BN2 5BE
21 University Hospitals Coventry and Warwickshire NHS Trust Coventry United Kingdom CV2 2DX
22 Rotherham, Doncaster And South Humber NHS Foundation Trust Doncaster United Kingdom DN4 8QN
23 Imperial College Healthcare NHS Trust London United Kingdom W2 1NY
24 Oxford University Hospital NHS Foundation Trust Oxford United Kingdom OX3 9DU
25 Zambart Lusaka Zambia

Sponsors and Collaborators

  • University of Oxford

Investigators

  • Principal Investigator: William Schilling, MD, Mahidol Oxford Tropical Medicine Research Unit

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT04303507
Other Study ID Numbers:
  • VIR20001
First Posted:
Mar 11, 2020
Last Update Posted:
May 4, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Coronavirus Infections
Hydroxychloroquine
Chloroquine

Study Results

No Results Posted as of May 4, 2022