Effect of SARS-CoV-2 Disease on Immune Responses, Disease Severity and Treatment Outcomes in Pulmonary Tuberculosis

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
National Institute for Research in Tuberculosis
RECRUITING
Chennai
Contact Information
Primary
SUBASH BABU, PhD
sbabu@icerindia.org
04428369500
Backup
Anuradha Rajamanickam, PhD
anuradha@icerindia.org
04428369500
Time Frame
Start Date: 2021-06-21
Estimated Completion Date: 2024-06-20
Participants
Target number of participants: 250
Treatments
TB patients with SARS-CoV-2 PCR+
50 TB patients with SARS-CoV-2 PCR+ will be recruited in group 1
TB patients with SARS-CoV-2 Ab+
100 TB patients with SARS-CoV-2 Ab+ will be recruited in group 2
TB patients negative for SARS-CoV-2 PCR and Ab
100 TB patients with SARS-CoV-2 PCR and Ab negative will be recruited in group 3
Sponsors
Leads: Tuberculosis Research Centre, India

This content was sourced from clinicaltrials.gov