COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04695197

Feiko ter Kuile, MD, PhD

Feiko.terKuile@lstmed.ac.uk

2021-01-05

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - laboratory confirmed sars-cov-2 infection, with positive molecular test results within the past 72 hours* - aged >=6 months ** - resident in the study area - the participant or caretaker is willing and able to give informed consent or assent with parent/guardian informed consent for participation in the study - agrees not to self-medicate with chloroquine, hydroxychloroquine or other antimalarials with potential anti-sars-cov-2 properties - not previously diagnosed with covid-19 - contactable by phone for follow-up permitting real-time, reliable information - uncomplicated malaria, defined as able to take oral medication - bodyweight ≥5kg - confirmed malaria infection by rdt (pldh) or microscopy

- unwilling or unable to provide informed consent/assent - the participant is judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results - inability/unlikely to be in the study area for the duration of the 28-day follow-up period - pregnant or lactating women - severe disease requiring parenteral treatment - currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine - received chloroquine in the last three days - inability/unlikely to be in the study area for the duration of the 42-day follow-up period - known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms - known chronic kidney disease (signs or symptoms of stage iv renal impairment or receiving dialysis) - known liver cirrhosis (child-pugh class b or greater) or signs or symptoms of severe hepatotoxicity

2

Liverpool School of Tropical Medicine

0

100

Burkina Faso;Kenya

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

142

Incidence of SARS-CoV-2 clearance

None

Phase 3

[{"arm_notes": "", "treatment_id": 117, "treatment_name": "Artemether lumefantrine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1046, "treatment_name": "Pyronaridine artesunate", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]