Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting
- Conditions
- COVID19Acute Respiratory IllnessesCoronavirus
- Interventions
- Drug: Placebo
- Registration Number
- NCT04303507
- Lead Sponsor
- University of Oxford
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4652
Not provided
- 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, or history of these medications within the previous 7 days
- Taking prohibited medications
- Known retinal disease
- Inability to be followed up for the trial period
- Known prolonged QT syndrome (however ECG is not required at baseline)
- Known pregnancy or women who are actively trying to become pregnant
- Prior diagnosis of porphyria
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Chloroquine or Hydroxychloroquine 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
- Primary Outcome Measures
Name Time Method Number of symptomatic COVID-19 infections Approximately 90 days Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups
- Secondary Outcome Measures
Name Time Method Number of symptomatic acute respiratory illnesses Approximately 90 days Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Symptoms severity of COVID-19 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 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.
Severity of symptomatic acute respiratory illnesses Approximately 90 days Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Trial Locations
- Locations (25)
Mbagathi County Hospital
🇰🇪Nairobi, Kenya
Hospital Of Mali
🇲🇱Bamako, Mali
The Aga Khan University Hospital
🇵🇰Karachi, Pakistan
Centre Hospitalier et Universitaire de Zone Abomey-Calavi
🇧🇯Abomey-Calavi, Benin
Hospital De Zone Allada
🇧🇯Allada, Benin
University Hospital Center of Angre
🇨🇮Abidjan, Côte D'Ivoire
Fountain Healthcare Hospital
🇰🇪Eldoret, Kenya
B.P. Koirala Institute of Health Sciences
🇳🇵Dharān Bāzār, Nepal
Zambart
🇿🇲Lusaka, Zambia
University Hospital Center of Bouake
🇨🇮Bouake, Côte D'Ivoire
The Bamako Hospital of Dermatology
🇲🇱Bamako, Mali
Faculty of Tropical Medicine, Mahidol University
🇹🇭Bangkok, Thailand
Airlangga University Hospital (UNAIR)
🇮🇩Surabaya, East Java, Indonesia
Husada Utama Hospital
🇮🇩Surabaya, East Java, Indonesia
Bunda Thamrin Hospital
🇮🇩Medan, North Sumatra, Indonesia
Murni Teguh Memorial Hospital
🇮🇩Medan, North Sumatra, Indonesia
Sardjito Hospital
🇮🇩Yogyakarta, Indonesia
The Dudley Group NHS Foundation Trust
🇬🇧Dudley, West Midlands, United Kingdom
Birmingham & Solihull Mental Health NHS Trust
🇬🇧Birmingham, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, United Kingdom
University Hospitals Of Morecambe Bay NHS Foundation Trust
🇬🇧Kendal, Cumbria, United Kingdom
Rotherham, Doncaster And South Humber NHS Foundation Trust
🇬🇧Doncaster, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Oxford University Hospital NHS Foundation Trust
🇬🇧Oxford, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom