Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso
MALCOV
2 other identifiers
interventional
143
2 countries
2
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-COV-2. An observational cohort study will be conducted in 708 newly diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be enrolled in hospitals with COVID-19 testing facilities from a source population screened for SARS-CoV-2 (N\~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be co-infected with malaria. They will be enrolled in the nested malaria treatment trial and randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease progression will be assessed and nasal swabs and blood samples will be taken during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42. Patients self-isolating will be phoned daily in between scheduled visits for the first 14 days to assess signs and symptoms. Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO clinical progression scale and FLU-PRO plus scales will be used to compare disease progression between COVID-19 patients with and without malaria, and by malaria. Other endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell responses, viral load and duration of viral carriage. Infection prevention and control (IPC), including the use of personal protection equipment (PPE), and measures for patient transport will follow national guidelines in each country. Written informed consent/assent will be sought. The study is anticipated to start in January 2021 and last for approximately 18 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 covid19
Started Jan 2021
Longer than P75 for phase_3 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedStudy Start
First participant enrolled
January 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2024
CompletedFebruary 23, 2024
February 1, 2021
1.8 years
December 14, 2020
February 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of SARS-CoV-2 clearance
Defined as the proportion of participants with a negative nasal swab on Day 7 after the start of treatment
by day 7
Secondary Outcomes (16)
Median viral load of SARS-CoV-2
by day 14
Cumulative incidence of SARS-CoV-2 clearance
by days 14, 21 and 28
Time to clearance of nasal SARS-CoV-2
by days 1, 3, 7, 14 and 28
Cumulative seroconversion rates (IgG, IgM, IgA)
by days 7, 14, 21 and 28
IgG, IgM, IgA antibody titres against SARS-CoV-2
by days 7, 14, 21 and 28
- +11 more secondary outcomes
Study Arms (2)
Artemether-lumefantrine
ACTIVE COMPARATORArtemether-lumefantrine, standard 3-day antimalarial treatment regimen.
Pyronaridine-artesunate
EXPERIMENTALPyronaridine-artesunate, standard 3-day antimalarial treatment regimen.
Interventions
Current first line treatment of malaria. Dose: Bodyweight (kg) Dose (mg) of artemether + lumefantrine given twice daily for 3 days (total, six doses) 5 to \< 15 20 + 120 15 to \< 25 40 + 240 25 to \< 35 60 + 360 \>=35 80 + 480; Twice daily for 3 days (total, six doses)
Antimalarial; Dose: Body weight (kg) Dose (mg) of pyronaridine + aresunate given once daily for 3 days (total, three doses) 5 to \< 8 60 + 20 8 to \<15 120 + 40 15 to \<20 180 + 60 20 to \<24 kg 180 + 60 24 to \<45 360 + 120 45 to \<65 540 + 180 \>=65 720 + 240; Once-daily for 3 days (total, three doses).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liverpool School of Tropical Medicinelead
- London School of Hygiene and Tropical Medicinecollaborator
- Kenya Medical Research Institutecollaborator
- Groupe de Recherche Action en Santecollaborator
- Centres for Disease Control and Prevention, Kenya.collaborator
- Bill and Melinda Gates Foundationcollaborator
- Centers for Disease Control and Preventioncollaborator
Study Sites (2)
Ouagadougou Hospitals
Ouagadougou, 06BP10248, Burkina Faso
Kisumu County Referral Hospital
Kisumu, 40100, Kenya
Related Publications (1)
Tangara B, Barsosio HC, Marlais T, Kabore JMT, Tiono AB, Otieno K, Wanjiku M, Achieng M, Onyango ED, Ondieki ED, Aura H, Odawo T, Allen DJ, Hannan L, Tetteh KK, Soulama I, Ouedraogo A, Serme SS, Soulama BI, Barry A, Badoum ES, Matthewman J, Brazal-Monzo H, Canizales J, Drabko A, Wu W, Kariuki S, Lesosky M, Sirima SB, Drakeley C, Ter Kuile FO. Artemether-lumefantrine versus pyronaridine-artesunate for the treatment of malaria in patients with mild to moderate COVID-19 in Kenya and Burkina Faso: a randomised open-label trial (MALCOV). EClinicalMedicine. 2026 Jan 3;91:103735. doi: 10.1016/j.eclinm.2025.103735. eCollection 2026 Jan.
PMID: 41552003DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kariuki Simon, PhD
Kenya Medical Research Institute
- PRINCIPAL INVESTIGATOR
Sirima Sodiomon, MD, PhD
Groupe de Recherche Action en Sante
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Masking: blinding of primary outcome assessor (off-site laboratory-based staff)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2020
First Posted
January 5, 2021
Study Start
January 8, 2021
Primary Completion
November 1, 2022
Study Completion
February 20, 2024
Last Updated
February 23, 2024
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- As soon as the full study findings have been published or based on any data requests that may occur during the study or analysis is still ongoing.
- Access Criteria
- Data access will be provided to researchers after a proposal has been approved by an independent review committee identified for this purpose. An agreement on how to collaborate will be reached based on any overlap between the proposal and any ongoing efforts. Proposals can be directed to email addresses provided in the publications and websites. To gain access, data requesters will need to sign a data-sharing agreement. The only limits to data sharing will be to safeguard research participants' confidentiality. External users will be bound by data-sharing agreements in line with the Data Sharing Policy from the respective Sponsors and the Gates Foundation to ensure that the privacy of individuals is protected. The agreement will prohibit any attempt to (a) identify study participants from the data or otherwise breach confidentiality, (b) make unapproved contact with study participants.
We will encourage data sharing to ensure that the scientific potential of this study is maximized. The full anonymized research database will be made publicly available as soon as the full study findings have been published or based on any data requests that may occur during the study or analysis is still ongoing. For the databases, we will use a controlled access approach.