Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Faculty Medicine of University of Indonesia, RSUPN Cipto Mangunkusumo, Eijkman Oxford Clinical Reserch Unit
No Registry
INA-QXZNETK
Tanggal Input Registry : 24-07-2020

01-08-2020
To determine if chloroquine or hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in health care workers
Secondary Outcome: 1. To determine if chloroquine or hydroxychloroquine prophylaxis attenuates COVID-19 infections 2. To determine if chloroquine or hydroxychloroquine prophylaxis prevents asymptomatic COVID-19 infection 3. To determine if chloroquine or hydroxychloroquine prophylaxis prevents all-cause symptomatic acute respiratory illnesses.
 
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)
Eksperimental
The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings. After obtaining fully informed consent, we will recruit healthcare workers, or other individuals at significant risk, who can be followed up reliably for up to 5 months. In Asia they will be randomised to receive either chloroquine or placebo (1:1 randomisation). In Europe they will be randomised to receive either hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10 mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or 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/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).
400
 

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) 4. Not previously diagnosed with COVID-19 5. Not currently symptomatic with an ARI 6. Participant works in healthcare facility or other well characterised high-risk environment 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 4. Taking a concomitant medication described in section 8.5, which cannot be safely stopped 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)
 
Ethics Committee of Faculty Medicine, University Indonesia No. KET-469/UN2.F1/ETIK/ PPM.00.02/2020 dated 04 May 2020 , Oxford Ethic Committee (OxTREC) Reference No. 25-20 dated 15 April 20
PPUK BPOM No. RG.01.06.1.3.07.20.08 dated 15 Jul 20
NCT04303507
dr. Erni Juwita Nelwan, PhD, SpPD_K-PTI,FACP,FINASIM, Departemen Ilmu Penyakit Dalam FKUI, Jl. Salemba Raya No. 6, Jakarta 10430,HP: 0811961229, Email: e.nelwan@gmail.com