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

COVID19 Clinical Trial

— COPCOV  

Official title:

Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303507
• Other study ID #: VIR20001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Respiratory Illnesses
• Coronavirus
• Coronavirus Infections
• COVID-19
• COVID19

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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