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Trial record 1 of 23 for:    chloroquine and covid-19
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Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting (COPCOV)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04303507
Recruitment Status : Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : March 27, 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 health care settings. After obtaining fully informed consent, the investigator will recruit healthcare workers, or other individuals at significant risk who can be followed reliably for 5 months. 40,000 participants will be recruited and the investigator predict an average of 400-800 participants per site in 50-100 sites.

The participant will be randomised to receive either chloroquine/ hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg, followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg hydroxychloroquine sulphate) will be taken for 3 months. Subsequent episodes of symptomatic respiratory illness, including symptomatic COVID-19, clinical outcomes, and asymptomatic infection with the virus causing COVID-19 will be recorded during the follow-up period. If they are diagnosed with COVID-19 during the period of prophylaxis, they will continue their prophylaxis unless advised to do so by their healthcare professional until they run out of their current supply of chloroquine/ hydroxychloroquine or placebo at home. They will not collect more. They will be followed up for 28 days (up until a maximum of 60 days if not recovered at 28 days).


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)
Estimated Study Start Date : April 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

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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Number of symptomatic acute respiratory illnesses [ Time Frame: Approximately 100 days ]
    Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

  3. Severity of symptomatic acute respiratory illnesses [ Time Frame: Approximately 100 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 100 days ]
    Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.



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

These are of two types:

A. Adult volunteers (exact age is dependent on countries) working as a healthcare worker or frontline (i.e. patient contact) in a healthcare facility or similar institution

B. Provided that they are willing to participate in the trial and can be followed adequately for up to 5 months, we may also enrol hospitalised patients or relatives exposed or potentially exposed to the SARS-CoV-2 virus or other high-risk groups

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)
  • Not previously diagnosed with COVID-19
  • Not currently symptomatic with an Acute Respiratory Infection
  • Participant A. works in healthcare facility or other well characterised high-risk environment, OR B. is an inpatient or relative of a patient in a participating hospital and likely exposed to COVID-19 infection or another high-risk group
  • 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
  • Taking a concomitant medication (Abiraterone acetate, Agalsidase, Conivaptan, Dabrafenib, Dacomitinib, Enzalutamide, Idelalisib, Mifepristone, Mitotane, tiripentol) which cannot be safely stopped
  • Known retinal disease
  • Inability to be followed up for the trial period
  • Known prolonged QT syndrome (however ECG is not required at baseline)

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

Sponsors and Collaborators
University of Oxford

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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: March 27, 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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Chloroquine
Chloroquine diphosphate
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics