Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso

Plain-language summary

This study investigated whether malaria is a risk factor for COVID-19 in Western Kenya and Burkina Faso, examining the antimalarial drugs Artemether-lumefantrine and Pyronaridine-artesunate. People aged 6 months or older with confirmed SARS-CoV-2 infection and uncomplicated malaria could take part. The study was conducted in Phase 3 and is completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Liverpool School of Tropical Medicine

Intervention

Artemether-lumefantrine (AL), Pyronaridine-artesunate (PA)

Start date

1/8/2021

Estimated completion

2/20/2024

Countries

Burkina Faso, Kenya

Related genes

Locations

• Ouagadougou, Burkina Faso
• Kisumu, Kenya

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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

Exclusion Criteria:

* 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