Investigating the immune response and gut microorganisms in people with COVID-19 and helminth infections
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
Run by National Institute of Allergy and Infectious Diseases (NIAID) · NCT04813328 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to see how COVID-19 and worm infections affect the immune system and gut bacteria in people aged 5 and older by collecting blood and stool samples from them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 1 site (Chennai, Tamilnadu) |
| Trial ID | NCT04813328 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 5 years or older living in the Tiruvallur district who can provide informed consent.
✕Probably not a fit
Patients with poor venous access or those with conditions that may increase risks associated with participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to collect samples from 1500 participants aged 5 years and older to analyze the immune response and intestinal microbiota in individuals with and without COVID-19 antibodies and helminth infections. Participants will undergo a one-time blood and stool collection for testing SARS-CoV-2 antibodies and diagnosing parasitic infections. The study will take place in the Tiruvallur district of Tamil Nadu, India, and will involve a single visit for each participant. Results from the clinical testing will be shared with participants, and referrals for medical care will be provided as necessary.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how helminth infections influence immune responses to COVID-19, potentially leading to improved treatment strategies.
How similar studies have gone: While this approach is relatively novel, similar studies exploring the interactions between infections and immune responses have shown promising insights.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER)
Chennai, Tamilnadu, India Recruiting
Study contacts
- Principal investigator: Subash Babu, MBBS, PhD — National Institute for Research in Tuberculosis
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.