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

COVID-19 Prevention Network

Status: Enrolling

Conditions: Tuberculosis

Treatments: Diagnostic Test: Clinical Evaluation at Day 4; Diagnostic Test: Laboratory Evaluation at week 26; Diagnostic Test: Clinical Evaluation at week 26; Diagnostic Test: Laboratory Evaluation at Day 4

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT06585683

CoVPN 3008 TB substudy

UM1AI068614 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

6,000 participants in 2 patient groups

Confirmed TB

Description:

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.

Treatment:

Diagnostic Test: Laboratory Evaluation at Day 4

Diagnostic Test: Clinical Evaluation at week 26

Diagnostic Test: Laboratory Evaluation at week 26

Diagnostic Test: Clinical Evaluation at Day 4

no TB (control)

Description:

Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples.

Treatment:

Diagnostic Test: Laboratory Evaluation at Day 4

Diagnostic Test: Clinical Evaluation at Day 4