OUTCOMES |
Type of outcome
|
Outcome
|
Timepoint(s) at which outcome measured
|
Primary Outcome |
Incidence of SARS-CoV-2 clearance (defined as the proportion of participants with a negative nasal swab) |
by day 7 |
Secondary Outcome |
• Median viral load of SARS-CoV-2 detected from mid-nasal swabs by PCR
|
by day 14 |
Secondary Outcome |
Cumulative incidence of SARS-CoV-2 clearance (defined as the proportion of participants with negative nasal swabs) |
by days 14, 21 and 28 |
Secondary Outcome |
Time to clearance of nasal SARS-CoV-2, defined as negative SARS-CoV-2 RNA PCR tests |
using data measured at days 1, 3, 7, 14 and 28 |
Secondary Outcome |
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 |
by days 7, 14, 21 and 28 |
Secondary Outcome |
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 |
by day 28 |
Secondary Outcome |
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 |
by day 42 |
Secondary Outcome |
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
|
by day 28 |
Secondary Outcome |
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 |
by day 7 |