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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
4,652
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
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
University Hospital Center of Bouake
Bouaké, Côte d’Ivoire
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
Fountain Healthcare Hospital
Eldoret, Kenya
...and 15 more locations
Number of symptomatic COVID-19 infections
Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups
Time frame: Approximately 90 days
Symptoms severity of COVID-19
Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.
Time frame: Approximately 90 days
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.
Time frame: Approximately 90 days
Number of symptomatic acute respiratory illnesses
Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Time frame: Approximately 90 days
Severity of symptomatic acute respiratory illnesses
Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Time frame: Approximately 90 days
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