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

NCT04930978 | Unknown

• 1 other identifier: 2020 041
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Respiratory Infection; Pulmonary Tuberculoses

Outcome Measures

Primary Outcomes (4)

• Number of participants with active TB

  Effects of SARS-CoV-2 on TB severity, altered Immunological and systems biological Measured by smear or GeneXpert

  Day 1

• Number of participants with COVID-19 infection

  Measured by real-time qPCR (quantitative polymerase chain reaction) assay

  Day 1

• Number of participants with SARS-CoV-2 antibodies

  Measured by SARS-CoV-2 serology

  Day 1

• Differences in immune responses between the groups

  Measured by immunological assays

  2 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of SARS-CoV-2 via RT-PCR or antibody testing. Diagnosis of TB and classification of TB treatment outcomes are as per National Tuberculosis Elimination program definitions.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tuberculosis Research Centre, India: lead

Study Sites (1)

National Institute for Research in Tuberculosis

Chennai, Tamil Nadu, 600031, India

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A portion of the samples (serum, cells) of each subject will be stored for future research, after obtaining informed consent from the subjects.

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anuradha Rajamanickam, PhD

  National Institute for Research in Tuberculosis-International Centers for Excellence in Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUBASH BABU, PhD

CONTACT

04428369500; sbabu@icerindia.org

Anuradha Rajamanickam, PhD

CONTACT

04428369500; anuradha@icerindia.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 18, 2021
• Study Start: June 21, 2021
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)