Understanding COVID-19 transmission and health impacts in Malawi

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Health center
  Blantyre, Malawi Recruiting
• BU School of Public Health, Global Health Department
  Boston, Massachusetts, United States Active not 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.