Tuberculosis Case Finding at the Completion of the CoVPN 3008 Clinical Trial: a Substudy to CoVPN 3008
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5,694
- Locations
- 41
- Primary Endpoint
- Proportion of participants with TB
Study Overview
Brief Summary
This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.
Detailed Description
This observational substudy will involve participants from the CoVPN 3008 trial, regardless of their HIV status, to study tuberculosis (TB). At the start, all participants will be screened for TB, even if they have no symptoms. They will receive chest x-rays and provide sputum samples for TB testing using Xpert Ultra, smear microscopy, and culture.
The study has two main groups. Group 1 includes participants with confirmed TB, and Group 2 includes participants without TB who will act as controls.
Participants with confirmed TB will start treatment and have a first follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. A second follow-up visit will take place at week 26 to evaluate their treatment progress, clinical outcomes, and TB status, ensuring they receive the necessary care.
Participants without TB will have a single follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. The study aims to identify potential biomarkers of TB by analyzing blood samples from both cases and controls, focusing on gene expression linked to TB, including hidden (subclinical) TB.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Enrollment into the CoVPN 3008 clinical trial.
- •Able and willing to complete the informed consent process: Volunteer demonstrates an understanding of this substudy.
- •Willingness to discuss TB status, undergo related testing/monitoring labs, and receive referrals for TB care.
Exclusion Criteria
- •Investigator's concern for difficulty with venous access based on clinical history and physical examination.
Arms & Interventions
Confirmed TB
Participants with confirmed TB will start treatment and have a follow-up visit soon after to check their TB symptoms again and collect blood samples. They will also have a second follow-up visit at week 26 to assess their treatment progress and TB status.
Intervention: Clinical Evaluation at Day 4 (Diagnostic Test)
Confirmed TB
Participants with confirmed TB will start treatment and have a follow-up visit soon after to check their TB symptoms again and collect blood samples. They will also have a second follow-up visit at week 26 to assess their treatment progress and TB status.
Intervention: Laboratory Evaluation at Day 4 (Diagnostic Test)
Confirmed TB
Participants with confirmed TB will start treatment and have a follow-up visit soon after to check their TB symptoms again and collect blood samples. They will also have a second follow-up visit at week 26 to assess their treatment progress and TB status.
Intervention: Clinical Evaluation at week 26 (Diagnostic Test)
Confirmed TB
Participants with confirmed TB will start treatment and have a follow-up visit soon after to check their TB symptoms again and collect blood samples. They will also have a second follow-up visit at week 26 to assess their treatment progress and TB status.
Intervention: Laboratory Evaluation at week 26 (Diagnostic Test)
no TB (control)
Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples.
Intervention: Clinical Evaluation at Day 4 (Diagnostic Test)
no TB (control)
Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples.
Intervention: Laboratory Evaluation at Day 4 (Diagnostic Test)
Outcomes
Primary Outcomes
Proportion of participants with TB
Time Frame: Measured at Day 1, Day 4 and week 26
The 95% confidence interval on the proportion of participants with TB will be estimated using the "score" method
Association parameters of each demographic variable with confirmed TB.
Time Frame: Measured at Day 1, Day 4 and week 26
Proportions and 95% CIs will be estimated using the score method. A multivariate analysis will also be conducted using generalized linear regression models with TB as the outcome.
Proportion of participants with confirmed TB at the six-month follow visit out of the total number of participants that are screened at the six-month visit and who had confirmed TB at their enrollment visit.
Time Frame: Measured at Day 1, Day 4 and week 26
Proportion and 95% CI will be estimated using the score method.
Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB.
Time Frame: Measured at Day 1, Day 4 and week 26
TB risk scores will be computed from RNA sequencing data generated from each participant's baseline whole-blood sample (Tempus tube) provided upon enrollment into CoVPN 3008. Association of each score with confirmed TB will be assessed using cross-validated ROC curve analysis with area under curve (AUC) 95% CI estimated using the Delong method.
Secondary Outcomes
No secondary outcomes reported