Status:
COMPLETED
Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting
Lead Sponsor:
University of Oxford
Conditions:
COVID19
Coronavirus
Eligibility:
All Genders
16+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- Participant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct
- Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals
- Adults (exact age is dependent on countries) less than 70 years old at the time of consent
- Not previously diagnosed with COVID-19
- Not currently symptomatic with an ARI
- Participant is a healthcare worker or is a person at risk of contracting COVID-19.
- Possesses an internet-enabled smartphone (Android or iOS)
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2022
Estimated Enrollment :
4652 Patients enrolled
Trial Details
Trial ID
NCT04303507
Start Date
April 29 2020
End Date
March 22 2022
Last Update
April 4 2023
Active Locations (25)
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1
Centre Hospitalier et Universitaire de Zone Abomey-Calavi
Abomey-Calavi, Benin
2
Hospital De Zone Allada
Allada, Benin
3
University Hospital Center of Angre
Abidjan, Côte d’Ivoire, BP 54378
4
University Hospital Center of Bouake
Bouaké, Côte d’Ivoire, BP 1174