ArticleEClinicalMedicine2026
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).
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04695197 (Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso), which is not on this map. Not yet cited in PubMed.
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Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso
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Abstract
Background: It is unknown whether the choice of malaria treatment for uncomplicated malaria affects coronavirus disease 2019 (COVID-19) severity, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load, or duration of viral shedding. Several antimalarials exhibit antiviral activity against SARS-CoV-2 Methods: We conducted an open-label randomised trial comparing standard 3-day treatment with PA and artemether-lumefantrine (AL) in newly diagnosed SARS-CoV-2 infected patients aged ≥6 months with rapid diagnostic test or microscopy-confirmed non-severe malaria in Kenya and Burkina Faso. SARS-CoV-2 was assessed by RT-PCR on days 3, 7, 14, and 28, and symptom resolution was assessed daily for 14 days using FLU-PRO Plus. The primary endpoint was the proportion of participants with SARS-CoV-2 clearance by day 7. Secondary endpoints included SARS-CoV-2 clearance by days 14, 21, and 28, time to SARS-CoV-2 clearance over 28 days, median viral load on day 7, and time to symptom resolution. Complete case analysis was conducted using log-binomial regression for binary outcomes, Cox-regression for time-to-event outcomes, and negative binomial regression for count outcomes, all adjusted for disease severity and viral load at enrolment. The trial is registered with ClinicalTrials.gov NCT04695197. Findings: From January 2021 to January 2022, 143 participants were randomised (PA = 69, AL = 74, intention-to-treat [ITT] population), including 117 with reverse transcription polymerase chain reaction (RT-PCR) confirmed (PA = 58, AL = 59, modified intention-to-treat [mITT] population) and 26 with rapid-antigen test confirmed SARS-CoV-2 infection. The median age was 19 years (interquartile range [IQR] 13-38), 66% were aged ≥15 years. Baseline characteristics were comparable. SARS-CoV-2 clearance by day 7 (primary endpoint) was 41% (22/54) with PA versus 58% (33/57) with AL (adjusted risk ratio [aRR] = 0.78, 95% confidence interval [CI] 0.45-1.35, p = 0.37); by day-14: PA = 80% (44/55) versus AL = 96% (55/57) (aRR = 0.86, 0.58-1.29, p = 0.47). Median (IQR) viral load on day 7 was higher with PA (855 [30-2883] versus AL:81 [12-209] copies/mL, p = 0.023). Time to SARS-CoV-2 clearance over 28 days was slower with PA (adjusted hazard ratio [aHR]: 0.55, 0.37-0.83, p = 0.004). Time to symptom clearance between treatments was similar (aHR = 1.01, 0.91-1.13, p = 0.79). Parasitological cure rates by day 42 were PA = 100% and AL = 99%. Five serious adverse events occurred (PA = 2, AL = 3) in three participants (PA = 1, AL = 2), including three hospitalisations (PA = 1, AL = 2), resulting in two deaths, both from respiratory failure (PA = 1, AL = 1). No serious adverse events (SAEs) were considered treatment-related. Interpretation: Pyronaridine-artesunate in COVID-19 patients co-infected with malaria was associated with slower viral clearance than standard treatment with artemether-lumefantrine but similar symptom resolution. Both treatments were highly effective as antimalarials and should continue to be considered first- or second-line treatment options for uncomplicated malaria in patients with mild to moderate COVID-19. Funding: Gates Foundation.
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