search
Back to results

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

Primary Purpose

COVID19, Coronavirus, Acute Respiratory Illnesses

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Chloroquine or Hydroxychloroquine
Placebo
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID19

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier et Universitaire de Zone Abomey-Calavi
  • Hospital De Zone Allada
  • University Hospital Center of Angre
  • University Hospital Center of Bouake
  • Airlangga University Hospital (UNAIR)
  • Husada Utama Hospital
  • Bunda Thamrin Hospital
  • Murni Teguh Memorial Hospital
  • Sardjito Hospital
  • Fountain Healthcare Hospital
  • Mbagathi County Hospital
  • The Bamako Hospital of Dermatology
  • Hospital Of Mali
  • B.P. Koirala Institute of Health Sciences
  • The Aga Khan University Hospital
  • Faculty of Tropical Medicine, Mahidol University
  • University Hospitals Of Morecambe Bay NHS Foundation Trust
  • The Dudley Group NHS Foundation Trust
  • Birmingham & Solihull Mental Health NHS Trust
  • Brighton and Sussex University Hospitals NHS Trust
  • University Hospitals Coventry and Warwickshire NHS Trust
  • Rotherham, Doncaster And South Humber NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • Oxford University Hospital NHS Foundation Trust
  • Zambart

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chloroquine or Hydroxychloroquine

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Symptoms severity of COVID-19
Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.
Number of asymptomatic cases of COVID-19
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.
Number of symptomatic acute respiratory illnesses
Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Severity of symptomatic acute respiratory illnesses
Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

Full Information

First Posted
March 6, 2020
Last Updated
April 3, 2023
Sponsor
University of Oxford
search

1. Study Identification

Unique Protocol Identification Number
NCT04303507
Brief Title
Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting
Acronym
COPCOV
Official Title
Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2020 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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. This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Coronavirus, Acute Respiratory Illnesses

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4652 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chloroquine or Hydroxychloroquine
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chloroquine or Hydroxychloroquine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of symptomatic COVID-19 infections
Description
Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups
Time Frame
Approximately 90 days
Secondary Outcome Measure Information:
Title
Symptoms severity of COVID-19
Description
Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.
Time Frame
Approximately 90 days
Title
Number of asymptomatic cases of COVID-19
Description
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.
Time Frame
Approximately 90 days
Title
Number of symptomatic acute respiratory illnesses
Description
Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Time Frame
Approximately 90 days
Title
Severity of symptomatic acute respiratory illnesses
Description
Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Time Frame
Approximately 90 days
Other Pre-specified Outcome Measures:
Title
Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.
Description
Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.
Time Frame
Approximately 90 days
Title
Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic.
Description
Number of days lost to work in relation to the treatment arm
Time Frame
Approximately 90 days
Title
Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs
Description
The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups.
Time Frame
Approximately 90 days
Title
Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L)
Description
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.
Time Frame
Approximately 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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) less than 70 years old at the time of consent Not previously diagnosed with COVID-19 Not currently symptomatic with an ARI Participant is a healthcare worker or is a person at risk of contracting COVID-19. Possesses an internet-enabled smartphone (Android or iOS) 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Schilling, MD
Organizational Affiliation
Mahidol Oxford Tropical Medicine Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier et Universitaire de Zone Abomey-Calavi
City
Abomey-Calavi
Country
Benin
Facility Name
Hospital De Zone Allada
City
Allada
Country
Benin
Facility Name
University Hospital Center of Angre
City
Abidjan
ZIP/Postal Code
BP 54378
Country
Côte D'Ivoire
Facility Name
University Hospital Center of Bouake
City
Bouake
ZIP/Postal Code
BP 1174
Country
Côte D'Ivoire
Facility Name
Airlangga University Hospital (UNAIR)
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60115
Country
Indonesia
Facility Name
Husada Utama Hospital
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60131
Country
Indonesia
Facility Name
Bunda Thamrin Hospital
City
Medan
State/Province
North Sumatra
ZIP/Postal Code
20112
Country
Indonesia
Facility Name
Murni Teguh Memorial Hospital
City
Medan
State/Province
North Sumatra
ZIP/Postal Code
20231
Country
Indonesia
Facility Name
Sardjito Hospital
City
Yogyakarta
ZIP/Postal Code
55281
Country
Indonesia
Facility Name
Fountain Healthcare Hospital
City
Eldoret
Country
Kenya
Facility Name
Mbagathi County Hospital
City
Nairobi
Country
Kenya
Facility Name
The Bamako Hospital of Dermatology
City
Bamako
ZIP/Postal Code
BP251
Country
Mali
Facility Name
Hospital Of Mali
City
Bamako
ZIP/Postal Code
BP3333
Country
Mali
Facility Name
B.P. Koirala Institute of Health Sciences
City
Dharān Bāzār
ZIP/Postal Code
56700
Country
Nepal
Facility Name
The Aga Khan University Hospital
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
Faculty of Tropical Medicine, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
University Hospitals Of Morecambe Bay NHS Foundation Trust
City
Kendal
State/Province
Cumbria
ZIP/Postal Code
LA9 7RG
Country
United Kingdom
Facility Name
The Dudley Group NHS Foundation Trust
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Birmingham & Solihull Mental Health NHS Trust
City
Birmingham
ZIP/Postal Code
B1 3RB
Country
United Kingdom
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Rotherham, Doncaster And South Humber NHS Foundation Trust
City
Doncaster
ZIP/Postal Code
DN4 8QN
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Oxford University Hospital NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Zambart
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
With participant's consent, suitably anonymised clinical data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future.
IPD Sharing URL
https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing
Citations:
PubMed Identifier
33570583
Citation
Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.
Results Reference
derived
Links:
URL
https://www.tropmedres.ac/covid-19/copcov
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs