NCT04813328

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

March 22, 2021

Last Update Submit

December 17, 2025

Conditions

COVID-19

Outcome Measures

Primary Outcomes (12)

  • Number of participants with helminth infections

    Measured by qPCR diagnostics of stool DNA extraction

    Day 1

  • Number of participants with SARS-CoV-2 antibodies

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

    Day 1

  • Number of participants with positive malaria test

    Measured by fingerprick blood samples

    Day 1

  • Average Differential blood count

    Measured from venipuncture blood samples

    Day 1

  • Average Hematocrit levels

    Measured from venipuncture blood samples

    Day 1

  • Number of participants with latent tuberculosis infection

    Measured by IFN-γ release assay

    Day 1

  • Number of participants with Wuchereria bancrofti infection

    Measured by enzyme-linked immunosorbent assay (ELISA)

    Day 1

  • Number of participants with Strongyloides stercoralis infection

    Measured by enzyme-linked immunosorbent assay (ELISA)

    Day 1

  • Number of participants with Ascaris infection

    Stool sample analysis DNA extraction for qPCR and 16S sequencing

    Day 1

  • Number of participants with hookworm infection

    Stool sample analysis DNA extraction for qPCR and 16S sequencing

    Day 1

  • Number of participants with Strongyloides infection

    Stool sample analysis using Baermann technique, DNA extraction for qPCR and 16S sequencing

    Day 1

  • Number of participants with Trichuris infection

    Stool sample analysis using DNA extraction for qPCR and 16S sequencing

    Day 1

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eligible participants will be enrolled from households in the Tiruvallur district, Tamil Nadu, India. Villages and towns in the Tiruvallur district will be selected in consultation with the Department of Public Health, Tamil Nadu. Areas that are known hotspots for COVID-19 will be selected.

You may qualify if:

  • Able to provide informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chennai, Tamil Nadu, India

Location

Related Publications (1)

  • 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.

    PMID: 38913614BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Coded PBMC, serum, stool RNA samples and data

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Subash Babu, MBBS, PhD

    National Institute for Research in Tuberculosis

    PRINCIPAL INVESTIGATOR

  • P'ng Loke, PhD

    National Institutes of Health (NIH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

June 1, 2021

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

IN(1)