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NCT Number: NCT04813328

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chennai, Tamil Nadu, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of participants with helminth infections

    Time frame: Day 1

    Measured by qPCR diagnostics of stool DNA extraction

  2. Number of participants with SARS-CoV-2 antibodies

    Time frame: Day 1

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

  3. Number of participants with positive malaria test

    Time frame: Day 1

    Measured by fingerprick blood samples

  4. Average Differential blood count

    Time frame: Day 1

    Measured from venipuncture blood samples

  5. Average Hematocrit levels

    Time frame: Day 1

    Measured from venipuncture blood samples

  6. Number of participants with latent tuberculosis infection

    Time frame: Day 1

    Measured by IFN-γ release assay

  7. Number of participants with Wuchereria bancrofti infection

    Time frame: Day 1

    Measured by enzyme-linked immunosorbent assay (ELISA)

  8. Number of participants with Strongyloides stercoralis infection

    Time frame: Day 1

    Measured by enzyme-linked immunosorbent assay (ELISA)

  9. Number of participants with Ascaris infection

    Time frame: Day 1

    Stool sample analysis DNA extraction for qPCR and 16S sequencing

  10. Number of participants with hookworm infection

    Time frame: Day 1

    Stool sample analysis DNA extraction for qPCR and 16S sequencing

  11. Number of participants with Strongyloides infection

    Time frame: Day 1

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

  12. Number of participants with Trichuris infection

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2021
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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