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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 : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE March 6, 2020
First Posted Date  ICMJE March 11, 2020
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE April 29, 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
Number of symptomatic COVID-19 infections [ Time Frame: Approximately 100 days ]
Number of symptomatic COVID-19 infections will be compared in subjects randomised to chloroquine or placebo
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Symptoms severity of COVID-19 [ Time Frame: Approximately 100 days ]
    Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.
  • Duration of COVID-19 [ Time Frame: Approximately 100 days ]
    Duration of COVID-19 will be compared between the two groups using a time to clinical improvement score.
  • Number of asymptomatic cases of COVID-19 [ Time Frame: Approximately 100 days ]
    Number of asymptomatic cases of COVID-19 will be determined by comparing acute and convalescent serology in the two groups.
  • Number of symptomatic acute respiratory illnesses [ Time Frame: Approximately 100 days ]
    The number of symptomatic acute respiratory illnesses will be compared in subjects randomised to chloroquine or placebo.
  • Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity. [ Time Frame: Approximately 100 days ]
    Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.
Current Other Pre-specified Outcome Measures
 (submitted: April 24, 2020)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: March 10, 2020)
Drug exposure-protection relationship [ Time Frame: Approximately 100 days ]
Whole blood pre-dose chloroquine concentrations measured monthly will be correlated with disease protection (if any)
 
Descriptive Information
Brief Title  ICMJE Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting
Official Title  ICMJE Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • COVID19
  • Coronavirus
  • Acute Respiratory Illnesses
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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

    Intervention: Drug: Chloroquine or Hydroxychloroquine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2020)
40000
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2020)
10000
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: William Schilling, MD +66 2 203-6333 William@tropmedres.ac
Listed Location Countries  ICMJE Indonesia,   Italy,   Lao People's Democratic Republic,   Pakistan,   Thailand,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04303507
Other Study ID Numbers  ICMJE VIR20001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Schilling, MD Mahidol Oxford Tropical Medicine Research Unit
PRS Account University of Oxford
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP