Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Liverpool School of Tropical Medicine
• Collaborators: Bill and Melinda Gates Foundation; Centers for Disease Control and Prevention; Centres for Disease Control and Prevention, Kenya.; Groupe de Recherche Action en Sante; Kenya Medical Research Institute; London School of Hygiene and Tropical Medicine
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Artesunate; Lumefantrine; Pyronaridine

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:

• 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