Identifying tuberculosis cases after a clinical trial
Tuberculosis Case Finding at the Completion of the CoVPN 3008 Clinical Trial: a Substudy to CoVPN 3008
This study is testing how to find cases of tuberculosis in people who took part in a previous trial to see if there are any signs of the disease and to help those who are affected.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | COVID-19 Prevention Network Research network |
| Locations | 41 sites (Gaborone and 40 other locations) |
| Trial ID | NCT06585683 on ClinicalTrials.gov |
What this trial studies
This observational substudy focuses on participants from the CoVPN 3008 trial to identify cases of tuberculosis (TB) after the trial's completion. All participants will undergo TB screening, including chest x-rays and sputum samples for testing. The study will categorize participants into two groups: those with confirmed TB who will receive treatment and follow-up, and those without TB who will serve as controls. The aim is to analyze blood samples for potential biomarkers linked to TB, including subclinical cases.
Who should consider this trial
Good fit: Ideal candidates are individuals who participated in the CoVPN 3008 trial and are willing to undergo TB testing and monitoring.
Not a fit: Patients who are not enrolled in the CoVPN 3008 trial or those with difficulties in venous access may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and treatment of tuberculosis, improving patient outcomes.
How similar studies have performed: Other studies have successfully identified TB cases through similar observational approaches, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gaborone and 40 other locations
- Gaborone CRS — Gaborone, Botswana (Recruiting)
- Eswatini Prevention Center CRS — Mbabane, Eswatini (Recruiting)
- Moi University Clinical Research Centre — Eldoret, Kenya (Recruiting)
- Kisumu Crs — Kisumu, Kenya (Recruiting)
- Kombewa Clinical Research Center — Kisumu, Kenya (Recruiting)
- Blantyre CRS — Blantyre, Malawi (Recruiting)
- Malawi CRS — Lilongwe, Malawi (Recruiting)
- Synergy Biomed Research Institute — East London, Eastern Cape, South Africa (Recruiting)
- Nelson Mandela Academic Research Unit CRS — Mthatha, Eastern Cape, South Africa (Recruiting)
- PHOENIX Pharma (Pty) Ltd — Port Elizabeth, Eastern Cape, South Africa (Recruiting)
- Josha Resarch CRS — Bloemfontein, Free State, South Africa (Recruiting)
- MeCRU CRS — Ga-Rankuwa, Gauteng, South Africa (Recruiting)
- Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS — Johannesburg, Gauteng, South Africa (Recruiting)
- Newtown Clinical Research — Johannesburg, Gauteng, South Africa (Recruiting)
- Soweto - Bara CRS — Johannesburg, Gauteng, South Africa (Recruiting)
- Wits RHI Ward 21 CRS — Johannesburg, Gauteng, South Africa (Recruiting)
- Tembisa Clinic 4 CoVPN CRS — Tembisa, Gauteng, South Africa (Recruiting)
- CAPRISA eThekwini CRS — Durban, KwaZulu-Natal, South Africa (Recruiting)
- Tongaat CRS — Durban, KwaZulu-Natal, South Africa (Recruiting)
- Vulindlela CRS — Durban, KwaZulu-Natal, South Africa (Recruiting)
- Isipingo CRS — Isipingo, KwaZulu-Natal, South Africa (Recruiting)
- Qhakaza Mbokodo Research Clinic CRS — Ladysmith, KwaZulu-Natal, South Africa (Recruiting)
- Aurum Institute Klerksdorp CRS — Klerksdorp, North West, South Africa (Recruiting)
- Rustenburg CRS — Rustenburg, North West, South Africa (Recruiting)
- Emavundleni CRS — Cape Town, Western Cape, South Africa (Recruiting)
- FAM-CRU (Family Clinical Research Unit) — Cape Town, Western Cape, South Africa (Recruiting)
- Groote Schuur HIV CRS — Cape Town, Western Cape, South Africa (Recruiting)
- Masiphumelele Clinical Research Site (MASI) CRS — Cape Town, Western Cape, South Africa (Recruiting)
- TASK Central — Cape Town, Western Cape, South Africa (Recruiting)
- Univeristy of Cape Town Lung CRS Institute — Cape Town, Western Cape, South Africa (Recruiting)
- TASK Eden — George, Western Cape, South Africa (Recruiting)
- Kliptown Soweto CRS — Johannesburg, South Africa (Recruiting)
- PHRU Matlosana CRS — Klerksdorp, South Africa (Recruiting)
- UVRI-IAVI HIV Vaccine Program LTD. CRS — Entebbe, Uganda (Recruiting)
- Baylor-Uganda CRS — Kampala, Uganda (Recruiting)
- Joint Clinical Research Centre — Kampala, Uganda (Recruiting)
- MU-JHU Research Collaboration CRS — Kampala, Uganda (Recruiting)
- Cfhrz Crs — Lusaka, Zambia (Recruiting)
- Matero Reference Clinic CRS — Lusaka, Zambia (Recruiting)
- UNC Global Projects / Kamwala District Health Centre — Lusaka, Zambia (Recruiting)
- Zambia Emory HIV Research Project - Ndola CoVPN CRS — Ndola, Zambia (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Manager
- Email: csopher@fredhutch.org
- Phone: 206-667-2144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.