Post-Trial Tuberculosis Case Finding: a Substudy of CoVPN 3008 (Ubuntu) (CoVPN3008TB)

COVID-19 Prevention Network

Status: Not yet enrolling

Conditions: Tuberculosis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06585683

CoVPN 3008 TB substudy

Details and patient eligibility

About

This substudy aims to identify cases of tuberculosis after the Ubuntu clinical trial (CoVPN 3008) is completed.

Full description

This observational substudy will involve participants from the CoVPN 3008 (Ubuntu) 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrollment into the CoVPN 3008 (Ubuntu) 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.