Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting (COPCOV)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04303507 |
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Recruitment Status :
Completed
First Posted : March 11, 2020
Last Update Posted : April 4, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID19 Coronavirus Acute Respiratory Illnesses | Drug: Chloroquine or Hydroxychloroquine Drug: Placebo | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4652 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 : | April 29, 2020 |
| Actual Primary Completion Date : | March 22, 2022 |
| Actual Study Completion Date : | March 22, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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 |
- 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
- Symptoms severity of COVID-19 [ Time Frame: Approximately 90 days ]Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.
- Number of asymptomatic cases of COVID-19 [ Time Frame: 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.
- Number of symptomatic acute respiratory illnesses [ Time Frame: Approximately 90 days ]Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
- Severity of symptomatic acute respiratory illnesses [ Time Frame: Approximately 90 days ]Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
- Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity. [ Time Frame: Approximately 90 days ]Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.
- Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic. [ Time Frame: Approximately 90 days ]Number of days lost to work in relation to the treatment arm
- Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs [ Time Frame: 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.
- Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L) [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303507
Show 25 study locations
| Principal Investigator: | William Schilling, MD | Mahidol Oxford Tropical Medicine Research Unit |
Documents provided by University of Oxford:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT04303507 |
| Other Study ID Numbers: |
VIR20001 |
| First Posted: | March 11, 2020 Key Record Dates |
| Last Update Posted: | April 4, 2023 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| URL: | https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Coronavirus Infections Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Hydroxychloroquine Chloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Amebicides |