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

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.

Conditions

• Covid-19
• Malaria

Interventions

DRUG

Artemether-lumefantrine (AL)

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)

DRUG

Pyronaridine-artesunate (PA)

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).

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• Groupe de Recherche Action en Sante

  collaborator OTHER

• Centres for Disease Control and Prevention, Kenya.

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Liverpool School of Tropical Medicine

  lead OTHER

Principal Investigators

• Kariuki Simon, PhD · Kenya Medical Research Institute

• Sirima Sodiomon, MD, PhD · Groupe de Recherche Action en Sante

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-08

Primary Completion

2022-11-01

Completion

2024-02-20

Countries

• Burkina Faso
• Kenya

Study Locations