Malaria COVID-19
Conditions
Interventions
Artemether lumefantrine
Sponsors
LSTM Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of SARS-CoV-2 clearance (defined as the proportion of participants with a negative nasal swab) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Median viral load of SARS-CoV-2 detected from mid-nasal swabs by PCR ;Cumulative incidence of SARS-CoV-2 clearance (defined as the proportion of participants with negative nasal swabs) ;Time to clearance of nasal SARS-CoV-2, defined as negative SARS-CoV-2 RNA PCR tests;Cumulative seroconversion rates (IgG, IgM, IgA) by days 7, 14, 21 and 28, and IgG, IgM, IgA antibody titres against SARS-CoV-2 by day-28 expressed as the geometric mean, maximum, and change from baseline;Inflammatory, genomic, and cellular immune responses to SARS-CoV-2 infection by multiplex serum cytokine markers; transcriptional profiling (gene expression) of whole blood and fixed whole blood for T and B cell markers;The clinical and parasitological antimalarial treatment response expressed as the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response. Recrudescence will be differentiated from new infection by genotyping of malaria parasites;COVID-19 disease progression and severity assessed by the duration and severity of OVID-19 symptoms, as defined by a severity index score, as well as the proportion of days with a fever after randomization, and the proportion of days with respiratory symptoms after randomization ;The safety of pyronaridine-artesunate and artemether-lumefantrine in COVID-19 patient coinfected with malaria parasites assessed as the cumulative proportion of treatment-related adverse events, serious adverse events, and adverse events resulting in treatment discontinuation by day 7 | — |
Countries
Burkina Faso, Kenya
Contacts
Public ContactHellen Barsosio
Co Principle investigator
Outcome results
None listed