COVID-TMMCOVID-19 Transmission and Morbidity in Malawi
Data Collection
Collected from today forward - ProspectiveCOVID-19+9
+ Coronaviridae Infections
+ Infections
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 17, 2023
Actual date on which the first participant was enrolled.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 hand, these conditions and deficiency of micronutrients may decrease the acquisition and longevity of antibodies induced by natural infection and SARS-CoV-2 vaccines, increasing the risk of re-infection and breakthrough infections to vaccination. To test these hypotheses, up to 200 symptomatic individuals (index cases)will be enrolled, their household contacts (anticipated \~700), and up to 600 vaccinees. The specific innate immune phenotypes that differentiate uninfected Malawians from Western controls (based on samples from blood banks) and whether those responses are protecting Malawians from infection and/or progression of disease will be assessed. Infected participants and vaccinees will be followed for up to 1.5 years to assess acquisition and longevity of Ab responses and memory B cells.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 5 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
BU School of Public Health, Global Health Department
Boston, United States