NCT04813328

The Effect of Helminth Infection Plus COVID-19 Infection on the Immune Response and Intestinal Microorganisms

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• COVID-19

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-03-24
• Last updated: 2025-12-18

Locations

1 site across 1 country: India