COVID-TMMCOVID-19 Transmission and Morbidity in Malawi
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveCOVID-19+9
+ Infections à Coronaviridae
+ Infections
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 17 janvier 2023
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.1500 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 5 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
BU School of Public Health, Global Health Department
Boston, United States