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

Recruiting

• Conditions: Tuberculosis

• Registration Number: NCT06585683
• Lead Sponsor: COVID-19 Prevention Network

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 Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-05
• Study Start: 2024-10-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-10-04
• Study Completion: 2025-10-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association parameters of each demographic variable with confirmed TB.	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.	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.	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.
Proportion of participants with TB	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

Trial Locations

Locations (41)

Gaborone CRS; 🇧🇼 Gaborone, Botswana

Eswatini Prevention Center CRS; 🇸🇿 Mbabane, Eswatini

Moi University Clinical Research Centre; 🇰🇪 Eldoret, Kenya

Kisumu Crs; 🇰🇪 Kisumu, Kenya

Kombewa Clinical Research Center; 🇰🇪 Kisumu, Kenya

Blantyre CRS; 🇲🇼 Blantyre, Malawi

Malawi CRS; 🇲🇼 Lilongwe, Malawi

Synergy Biomed Research Institute; 🇿🇦 East London, Eastern Cape, South Africa

Nelson Mandela Academic Research Unit CRS; 🇿🇦 Mthatha, Eastern Cape, South Africa

PHOENIX Pharma (Pty) Ltd; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Scroll for more (31 remaining)