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Completed

NCT Number: NCT06585683

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

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

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaborone CRS, Gaborone, Botswana

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Evaluation at Day 4

Diagnostic Test

Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB

Laboratory Evaluation at Day 4

Diagnostic Test

Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.

Clinical Evaluation at week 26

Diagnostic Test

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.

Laboratory Evaluation at week 26

Diagnostic Test

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

COVID-19 Prevention Network

Network

Collaborators

  • Medical Research Council, South Africa
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Acronym: CoVPN3008TB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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