Understanding COVID-19 transmission and health impacts in Malawi
COVID-19 Transmission and Morbidity in Malawi
Boston University · NCT05973084
This study is trying to understand why COVID-19 seems to affect people in Malawi less severely by looking at factors like immune responses and other health conditions in those who have the virus and their close contacts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 5 Years to 75 Years |
| Sex | All |
| Sponsor | Boston University (other) |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05973084 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the unique factors contributing to lower COVID-19 morbidity and mortality rates in Malawi compared to other regions. It will enroll symptomatic individuals with confirmed SARS-CoV-2 infections, their household contacts, and vaccinated individuals to assess the role of innate immune responses, malaria, and intestinal parasites in influencing susceptibility to infection and vaccine responses. Participants will be followed for up to 1.5 years to evaluate antibody responses and memory B cell longevity.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 5 to 75 years with confirmed COVID-19 symptoms living in Blantyre, Malawi, and their household contacts.
Not a fit: Patients who have received a SARS-CoV-2 vaccine in the previous 3 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into protective immune factors that may inform COVID-19 prevention and treatment strategies in similar populations.
How similar studies have performed: While there have been studies on COVID-19 transmission and immunity, this specific focus on the interplay of malaria, intestinal parasites, and innate immunity in a sub-Saharan context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Index Cases 1. Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test; 2. Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers for the following 6 months; 3. Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age; 4. Has not received a SARS-CoV-2 vaccine in the previous 3 months 5. Willingness to comply with study procedures and visits, and provides informed consent. Household Contacts of the Confirmed SARS-CoV-2 Case 1. Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers in the following 6 months; 2. Willingness to comply with study procedures and follow-up visits and provides informed consent. 3. Has not received a SARS-CoV-2 vaccine in the previous 3 months Vaccinees 1\) Aged 18 years to 75 years; 2) Willingness to receive the primary regimen of the AZ and/or JJ vaccines 2) Not in the other 2 cohorts; 4) Willingness to comply with study procedures and follow-up visits and provides informed consent. 5\) Has not received a prior dose of a SARS-CoV-2 vaccine Exclusion Criteria Index Cases 1. Conditions that precludes from adherence to the visit schedule; 2. 50% or more of household members decline to participate. 3. Pregnancy at the enrollment visit 4. Long term use of cotrimoxazole prophylaxis Household Contacts of the Confirmed SARS-CoV-2 Case 1. Conditions that preclude adherence to the visit schedule. 2. Participants with 2 consecutive negative SARS-CoV-2 RT-PCRs will be excluded from visits after M1. 3. Pregnancy at the enrollment visit 4. Long term use of cotrimoxazole prophylaxis Vaccinees 1. Conditions that preclude adherence to the visit schedule. 2. Pregnancy at the enrollment visit 3. Long term use of cotrimoxazole prophylaxis
Where this trial is running
Boston, Massachusetts and 1 other locations
- BU School of Public Health, Global Health Department — Boston, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
- Health center — Blantyre, Malawi (RECRUITING)
Study contacts
- Principal investigator: Clarissa Valim, MD ScD — BU School of Public Health, Department of Global Health
- Study coordinator: Clarissa Valim, MD ScD
- Email: cvalim@bu.edu
- Phone: (617) 414-1260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: SARS CoV 2 Infection, SARS CoV 2 Vaccination, Natural infection, Immune phenotypes, Innate immunity, SARS CoV 2 adaptive immunity, SARS CoV 2 antibody response, Vacinees