COVID-19 Transmission and Morbidity in Malawi

Launched by BOSTON UNIVERSITY · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "COVID-19 Transmission and Morbidity in Malawi," aims to understand why COVID-19 has affected people in sub-Saharan Africa differently than in Europe and the Americas. Researchers are investigating how factors like the immune system, malaria, and other infections may influence the risk of getting COVID-19, the severity of the disease, and how well vaccines work. They want to gather information from individuals who have been diagnosed with COVID-19 and their household contacts, as well as from those who are willing to receive a COVID-19 vaccine.

To participate in this study, you must be between 5 and 75 years old and living in Blantyre, Malawi. You should be experiencing symptoms of COVID-19, have a confirmed diagnosis, and have not received a COVID-19 vaccine in the last three months. Participants will attend scheduled visits for health assessments and provide consent to be part of the study. This research could help uncover important information about how COVID-19 spreads and affects people in different regions, ultimately improving our understanding and responses to the virus.

Gender

ALL

Eligibility 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