NCT06585683

Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008

Tuberculosis Case Finding at the Completion of the CoVPN 3008 Clinical Trial: a Substudy to CoVPN 3008

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,694 (actual)
• Sponsor: COVID-19 Prevention Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clinical Evaluation at Day 4	Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB
DIAGNOSTIC_TEST	Laboratory Evaluation at Day 4	Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.
DIAGNOSTIC_TEST	Clinical Evaluation at week 26	Participants will undergo another complete physical exam and have their medical (including TB) history, potential TB signs/symptoms, and concomitant medications reassessed. Chest radiography will be obtained for all participants. An assessment of TB outcomes will also be performed.
DIAGNOSTIC_TEST	Laboratory Evaluation at week 26	Peripheral blood samples, including serum, PBMC, and whole blood, will be collected. Participants not previously identified as living with HIV will undergo HIV diagnostic testing, while participants living with HIV will have their HIV viral load and CD4+ T-cell count measured.

Timeline

• Start date: 2024-09-13
• Primary completion: 2025-03-28
• Completion: 2025-05-21
• First posted: 2024-09-05
• Last updated: 2026-01-26

Locations

41 sites across 7 countries: Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, Zambia