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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-04-30

Brief Summary

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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

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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

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COVID-19

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Subash Babu, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute for Research in Tuberculosis

P'ng Loke, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health (NIH)

Locations

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National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER)

Chennai, Tamil Nadu, India

Site Status

Countries

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India

References

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Ferris BF, Balasubramanian S, Rajamanickam A, Munisankar S, Dasan B, Menon PA, Loke P, Babu S, Chami GF. Relative contribution of biomedical, demographic, and socioeconomic factors to COVID-19 vaccine receipt in rural India. PLoS One. 2024 Jun 24;19(6):e0305819. doi: 10.1371/journal.pone.0305819. eCollection 2024.

Reference Type BACKGROUND

PMID: 38913614 (View on PubMed)

Other Identifiers

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SARS-CoV-2/helminth

Identifier Type: -

Identifier Source: org_study_id