An observational study in Tuberculosis, sponsored by COVID-19 Prevention Network. Completed at 41 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by COVID-19 Prevention Network · Observational
This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 5,694 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →COVID-19 Prevention Network is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will involve approximately 6,000 volunteers who previously participated in the parent study, CoVPN 3008. Although volunteers may meet the inclusion/exclusion criteria, certain medical, psychiatric, occupational, or other conditions could complicate the evaluation of safety and/or immunogenicity, making some individuals unsuitable for enrollment or retention in the trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Clinical Evaluation at Day 4 · Diagnostic Test: Laboratory Evaluation at Day 4 · Diagnostic Test: Clinical Evaluation at week 26 · Diagnostic Test: Laboratory Evaluation at week 26
Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples.
Diagnostic Test: Clinical Evaluation at Day 4 · Diagnostic Test: Laboratory Evaluation at Day 4
Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB
Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.
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.
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.
Proportion of participants with TB
The 95% confidence interval on the proportion of participants with TB will be estimated using the "score" method
Time frame: Measured at Day 1, Day 4 and week 26
Association parameters of each demographic variable with confirmed TB.
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.
Time frame: Measured at Day 1, Day 4 and week 26
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.
Proportion and 95% CI will be estimated using the score method.
Time frame: Measured at Day 1, Day 4 and week 26
Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB.
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.
Time frame: Measured at Day 1, Day 4 and week 26
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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