Last reviewed · How we verify
NCT04930978: COVID-19-TB
Effect of SARS-CoV-2 Disease on Immune Responses, Disease Severity and Treatment Outcomes in Pulmonary Tuberculosis
trial in COVID-19 Respiratory Infection in 250 participants. Status unknown.
20 June 2024
Quick facts
| Lead sponsor | Tuberculosis Research Centre, India |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 21 June 2021 |
| Primary completion | 20 June 2024 |
| Estimated completion | 20 June 2024 |
| Sites | 1 location across India |
Conditions studied
- COVID-19 Respiratory Infection — all drugs for COVID-19 Respiratory Infection →
- Pulmonary Tuberculoses — all drugs for Pulmonary Tuberculoses →
Sponsor
Tuberculosis Research Centre, India — full company profile →
Who can join
Adults 18 to 65, any sex, with COVID-19 Respiratory Infection or Pulmonary Tuberculoses. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the Coronavirus disease (COVID-19). Tuberculosis (TB) is the foremost cause of infectious deaths globally. In 2025, an additional 1.4 million TB deaths could occur as direct consequence of the COVID-19 pandemic. It is postulated that individuals with latent or active TB are more susceptible to SARS-CoV-2 disease and that COVID-19 disease rate is high in patients with active TB, although the evidence is still scarce. TB and SARS-CoV-2 are both infectious diseases which primarily attack the alveolar region of the lungs and share common symptoms. SARS-CoV-2 disease can induce innate and adaptive immunity, but uncontrolled inflammatory innate immunity and impaired adaptive immune responses may be associated with severe tissue damage, both locally and systemically. People with coinfection (COVID-19 and TB disease) might potentially have impaired protective immune responses and treatment outcomes, specifically as far as anti-tuberculosis treatment is concerned. However, very little is known about the immunological underpinnings in this interface between TB and COVID-19 on the effect of SARS-CoV-2 disease on disease severity, response to treatment and treatment outcomes in pulmonary tuberculosis. Investigators hypothesize that altered immunity due to prior or present asymptomatic disease with SARS-CoV-2 virus can lead to altered immune responses and systems biology, increased severity and altered treatment outcomes in TB disease. The main objective of the study would be to evaluate the baseline differences in immune cells populations immune cell responses at baseline and at the time of treatment (2nd month) and end of treatment. Further, Investigators would be evaluating the changes in proteomic profiles in a subset of these individuals. In addition, immunological assays examining differences in T cell populations, measuring levels of various cytokines and by immunophenotyping as well as other immune parameters related to innate and adaptive responses will be performed to enhance the understanding of the immunological cross-talk between active TB patients with or without SARS-CoV-2. The secondary objective would be to study the clinical features, disease severity, mycobacterial burden and treatment outcomes in a cohort of SARS-CoV-2 infected (asymptomatic PCR or Antibody+) and non-infected patients with active pulmonary TB.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04930978
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19 Respiratory Infection
Currently open trials in the same condition.
- NCT06950177 — Pancoronavirus Vaccine Study in Healthy Adults · Phase 1 · active not recruiting
- NCT06402318 — Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine · recruiting
- NCT05765396 — SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies · active not recruiting
- NCT05689034 — Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 · Phase 2, PHASE3 · recruiting
- NCT05562505 — Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure · NA · recruiting
Other Tuberculosis Research Centre, India trials
Trials by the same sponsor.
- NCT05047055 — Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients · unknown
- NCT05040126 — Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India · Phase 3 · unknown
- NCT05049187 — Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers · completed
- NCT04844242 — MISC COVID-19 Study in Pediatric Population · recruiting
- NCT05044910 — The Impact of Malnutrition on Immune Responses to Tuberculosis · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04930978 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tuberculosis Research Centre, India
- Last refreshed: 22 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04930978.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing