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

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ClinicalTrials.gov Identifier: NCT04303507
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other staff working in a facility where there are cases of either proven, or suspected, COVID-19, who can be followed reliably for 5 months. 40,000 participants will be recruited 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
COVID19 Coronavirus Acute Respiratory Illnesses Drug: Chloroquine or Hydroxychloroquine Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 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
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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.

  4. 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.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Study Participants The study population is adult healthcare workers and other staff working in a facility where there are cases of either proven or suspected 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 works in a facility where there are cases of either proven or suspected 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
  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

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


Information from the National Library of Medicine

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


Contacts
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Contact: William Schilling, MD +66 2 203-6333 William@tropmedres.ac

Locations
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Thailand
Faculty of Tropical Medicine, Mahidol University Active, not recruiting
Bangkok, Thailand, 10400
United Kingdom
Brighton and Sussex University Hospitals NHS Trust Recruiting
Brighton, United Kingdom, BN2 5BE
Contact: Martin Llewellyn, MD       M.J.Llewelyn@bsms.ac.uk   
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W2 1NY
Contact: Alan Winton Okeefe         
Oxford University Hospital NHS Foundation Trust Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Charlie Woodrow, MD       cjwoodrow@talk21.com   
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: William Schilling, MD Mahidol Oxford Tropical Medicine Research Unit
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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: July 15, 2020
Last Verified: March 2020
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Chloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides