Impact of COVID-19 on immune responses and treatment outcomes in tuberculosis patients
Effect of SARS-CoV-2 Disease on Immune Responses, Disease Severity and Treatment Outcomes in Pulmonary Tuberculosis
This study looks at how COVID-19 affects the immune system and treatment results in people who have just been diagnosed with tuberculosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tuberculosis Research Centre, India Government |
| Locations | 1 site (Chennai, Tamilnadu) |
| Trial ID | NCT04930978 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how SARS-CoV-2 infection affects immune responses, disease severity, and treatment outcomes in patients with pulmonary tuberculosis (TB). It aims to understand the relationship between COVID-19 and TB, particularly focusing on individuals who are newly diagnosed with TB and may also have SARS-CoV-2 infection. The study will assess immune responses and potential complications arising from co-infection, providing insights into the management of these diseases. Participants will be monitored for their immune responses and treatment progress over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who are newly diagnosed with smear or GeneXpert positive tuberculosis, with or without current or prior asymptomatic COVID-19.
Not a fit: Patients with a history of prior tuberculosis episodes, drug-resistant TB, or those with certain comorbidities like diabetes or HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with co-infection of COVID-19 and tuberculosis.
How similar studies have performed: While the relationship between COVID-19 and tuberculosis is being explored, this specific observational approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age group 18-65; * Newly diagnosed smear or GeneXpert positive for TB with or without SARS-CoV-2 (present or prior asymptomatic) disease; * Willing to provide written informed consent. Exclusion Criteria: * Any prior episode of TB disease; * Treatment for current TB episode \>1 week before enrollment; * Drug resistance TB patients; * Pregnancy or childbirth within last 6 months; * Diabetes, HIV-seropositive and current use of immunosuppressive and steroid therapy Mild, Moderate and severe Covid-19 disease.
Where this trial is running
Chennai, Tamilnadu
- National Institute for Research in Tuberculosis — Chennai, Tamilnadu, India (Recruiting)
Study contacts
- Principal investigator: Anuradha Rajamanickam, PhD — National Institute for Research in Tuberculosis-International Centers for Excellence in Research
- Study coordinator: SUBASH BABU, PhD
- Email: sbabu@icerindia.org
- Phone: 04428369500
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.