Official Title
A Pilot Study of the Effects of Helminth Infection and SARS-CoV-2 Seropositivity on Immune Response and the Intestinal Microbiota in India
Brief Summary

This is a pilot, cross-sectional, sample collection study to characterize the immuneresponse and intestinal microorganisms in people with and without COVID-19 antibodies andhelminth infection.

Detailed Description

This is a pilot, cross-sectional, sample collection study to characterize the immune
response and intestinal microbiota in people with and without SARS-CoV-1 antibodies and
helminth infection.

A target sample size of 1500 participants aged 5 years or older will undergo a one-time
blood and stool collection for SARS-CoV-2 antibody testing, diagnosis of parasitic
infections, and experimental studies including transcriptomics (RNA) and microbiome
(intestinal microorganisms) characterization. Participants willing to take part in the
study will be selected from households in the Tiruvallur district, Tamil Nadu, India.
Individual study participation involves a single study visit. Participants will be
informed of the results of clinical testing and will be referred for medical care as
appropriate.

Recruiting
COVID-19
Eligibility Criteria

Inclusion Criteria:

- Able to provide informed consent.

Exclusion Criteria:

- Poor venous access precluding venipuncture.

- History of any illness or condition which, in the investigator's judgment, may
substantially increase the risk associated with the participant's participation in
the protocol, or compromise the scientific objectives.

Participants may be co-enrolled in other studies; however study staff should be notified
of co-enrollment.

Eligibility Gender
All
Eligibility Age
Minimum: 5 Years ~ Maximum: N/A
Countries
India
Locations

National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER)
Chennai, Tamilnadu, India

Investigator: Subash Babu, MBBS, PhD
Contact: 044-28369711
sbabu@icerindia.org

National Institute of Allergy and Infectious Diseases (NIAID)
NCT Number
MeSH Terms
COVID-19
Helminthiasis