COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN10207947

Dr William Schilling

William@tropmedres.ac

2020-07-21

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Current participant inclusion criteria as of 03/06/2021: 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) Previous participant inclusion criteria: 1. 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) <70 years old at the time of consent 4. Not previously diagnosed with COVID-19 5. Not currently symptomatic with an ARI 6. Working in a facility where there are cases of either proven or suspected COVID-19 7. Possesses an internet-enabled smartphone (Android or iOS)

Current participant exclusion criteria as of 03/06/2021: 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 any of the following prohibited medications: 4.1. Antiarrhythmic medications: digoxin, amiodarone, sotalol, flecainide 4.2. Antiparasitic/malarial agents: mefloquine, halofantrine, praziquantel 4.3. Antibiotics: levofloxacin, moxifloxacin, ciprofloxacin, azithromycin, clarithromycin, erythromycin 4.4. Antifungal drugs: fluconazole, ketoconazole, itraconazole, terfenadine 4.5. Psychoactive drugs: lithium, quetiapine, chlorpromazine, thioridazine, ziprasidone, haloperidol, droperidol, methadone 4.6. Migraine treatment: sumatriptan 4.7. Antihistamines: astemizole 4.8. Antiemetics: prochlorperazine, metoclopramide 4.9. Cancer treatments: abiraterone, dabrafenib, dacomitinib, enzalutamide, idelalisib, mitotane 4.10. Other specific drugs: ciclosporin, conivaptan, agalsidase alfa or beta, mifepristone, stiripentol 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 11. The investigator may consult the physician’s guidance documents for any further questions regarding the eligibility of potential participants. Previous participant 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 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

3

University of Oxford

18

70

Benin;Ethiopia;Indonesia;Kenya;Lao People's Democratic Republic;Mali;Niger;Pakistan;Thailand;United Kingdom;Zambia

Health workers

N/A

40000

The number of symptomatic COVID-19 infections will be compared between participants randomised to chloroquine or hydroxychloroquine; and placebo groups between baseline and 90 days

Phase 3

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]