Status:
COMPLETED
Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso
Lead Sponsor:
Liverpool School of Tropical Medicine
Collaborating Sponsors:
London School of Hygiene and Tropical Medicine
Kenya Medical Research Institute
Conditions:
Covid-19
Malaria
Eligibility:
All Genders
6-100 years
Phase:
PHASE3
Brief Summary
It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-...
Detailed Description
Background: In Africa, COVID-19 has the potential to cripple the continent's fragile healthcare systems and be devastating economically. It is unknown whether malaria infection worsens COVID-19, affec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT04695197
Start Date
January 8 2021
End Date
February 20 2024
Last Update
February 23 2024
Active Locations (2)
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1
Ouagadougou Hospitals
Ouagadougou, Burkina Faso, 06BP10248
2
Kisumu County Referral Hospital
Kisumu, Kenya, 40100