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COVID-19 Transmission and Morbidity in Malawi

Recruitingn/aAges 5 Years - 75 YearsAllBoston University
NCT05973084 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination. Study objectives 1. Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi 2. Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses. 3. Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

2 sites
BU School of Public Health, Global Health Department
Boston, United States
Health center
Blantyre, Malawi
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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