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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04303507
Other study ID # VIR20001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 29, 2020
Est. completion date March 22, 2022

Study information

Verified date May 2022
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 4652
Est. completion date March 22, 2022
Est. primary completion date March 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


Intervention

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
Placebo

Locations

Country Name City State
Benin Centre Hospitalier et Universitaire de Zone Abomey-Calavi Abomey-Calavi
Benin Hospital De Zone Allada Allada
Côte D'Ivoire University Hospital Center of Angre Abidjan
Côte D'Ivoire University Hospital Center of Bouake Bouake
Indonesia Bunda Thamrin Hospital Medan North Sumatra
Indonesia Murni Teguh Memorial Hospital Medan North Sumatra
Indonesia Airlangga University Hospital (UNAIR) Surabaya East Java
Indonesia Husada Utama Hospital Surabaya East Java
Indonesia Sardjito Hospital Yogyakarta
Kenya Fountain Healthcare Hospital Eldoret
Kenya Mbagathi County Hospital Nairobi
Mali Hospital Of Mali Bamako
Mali The Bamako Hospital of Dermatology Bamako
Nepal B.P. Koirala Institute of Health Sciences Dharan Bazar
Pakistan The Aga Khan University Hospital Karachi
Thailand Faculty of Tropical Medicine, Mahidol University Bangkok
United Kingdom Birmingham & Solihull Mental Health NHS Trust Birmingham
United Kingdom Brighton and Sussex University Hospitals NHS Trust Brighton
United Kingdom University Hospitals Coventry and Warwickshire NHS Trust Coventry
United Kingdom Rotherham, Doncaster And South Humber NHS Foundation Trust Doncaster
United Kingdom The Dudley Group NHS Foundation Trust Dudley West Midlands
United Kingdom University Hospitals Of Morecambe Bay NHS Foundation Trust Kendal Cumbria
United Kingdom Imperial College Healthcare NHS Trust London
United Kingdom Oxford University Hospital NHS Foundation Trust Oxford
Zambia Zambart Lusaka

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Countries where clinical trial is conducted

Benin,  Côte D'Ivoire,  Indonesia,  Kenya,  Mali,  Nepal,  Pakistan,  Thailand,  United Kingdom,  Zambia, 

Outcome

Type Measure Description Time frame Safety issue
Other Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity. Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity. Approximately 90 days
Other Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic. Number of days lost to work in relation to the treatment arm Approximately 90 days
Other Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups. Approximately 90 days
Other Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L) 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. Approximately 90 days
Primary Number of symptomatic COVID-19 infections Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups Approximately 90 days
Secondary Symptoms severity of COVID-19 Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score. Approximately 90 days
Secondary 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. Approximately 90 days
Secondary Number of symptomatic acute respiratory illnesses Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups. Approximately 90 days
Secondary Severity of symptomatic acute respiratory illnesses Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups. Approximately 90 days
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