Status:
RECRUITING
COVID-19 Transmission and Morbidity in Malawi
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Malaria Alert Center, Kamuzu University of Health Sciences
Conditions:
SARS CoV 2 Infection
SARS CoV 2 Vaccination
Eligibility:
All Genders
5-75 years
Brief Summary
SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower th...
Detailed Description
The investigators hypothesize that malaria and intestinal parasitic diseases may result in enhanced or tolerogenic innate immune responses that decrease the risk of symptomatic COVID-19. On the other ...
Eligibility Criteria
Inclusion
- Inclusion Criteria Index Cases
- Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test;
- 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;
- Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age;
- Has not received a SARS-CoV-2 vaccine in the previous 3 months
- Willingness to comply with study procedures and visits, and provides informed consent.
- Household Contacts of the Confirmed SARS-CoV-2 Case
- 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;
- Willingness to comply with study procedures and follow-up visits and provides informed consent.
- 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
- Conditions that precludes from adherence to the visit schedule;
- 50% or more of household members decline to participate.
- Pregnancy at the enrollment visit
- Long term use of cotrimoxazole prophylaxis
- Household Contacts of the Confirmed SARS-CoV-2 Case
- Conditions that preclude adherence to the visit schedule.
- Participants with 2 consecutive negative SARS-CoV-2 RT-PCRs will be excluded from visits after M1.
- Pregnancy at the enrollment visit
- Long term use of cotrimoxazole prophylaxis
- Vaccinees
- Conditions that preclude adherence to the visit schedule.
- Pregnancy at the enrollment visit
- Long term use of cotrimoxazole prophylaxis
Exclusion
Key Trial Info
Start Date :
January 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05973084
Start Date
January 17 2023
End Date
March 1 2028
Last Update
June 27 2025
Active Locations (2)
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1
BU School of Public Health, Global Health Department
Boston, Massachusetts, United States, 02118
2
Health center
Blantyre, Malawi