AzTrials
AzTrials

COVID-19NCT04813328

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

An observational study of COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
How many people
1,500 participants
Where
1 siteIndia
Study dates
1 Jun 2021to Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • Able to provide informed consent.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

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

    Chennai, Tamil Nadu

Other trials in India

About this study

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

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.

Read the 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
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with helminth infections

    Measured by qPCR diagnostics of stool DNA extraction

    Measured: Day 1

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

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

    Measured: Day 1

  3. Number of participants with positive malaria test

    Measured by fingerprick blood samples

    Measured: Day 1

  4. Average Differential blood count

    Measured from venipuncture blood samples

    Measured: Day 1

  5. Average Hematocrit levels

    Measured from venipuncture blood samples

    Measured: Day 1

  6. Number of participants with latent tuberculosis infection

    Measured by IFN-γ release assay

    Measured: Day 1

  7. Number of participants with Wuchereria bancrofti infection

    Measured by enzyme-linked immunosorbent assay (ELISA)

    Measured: Day 1

  8. Number of participants with Strongyloides stercoralis infection

    Measured by enzyme-linked immunosorbent assay (ELISA)

    Measured: Day 1

  9. Number of participants with Ascaris infection

    Stool sample analysis DNA extraction for qPCR and 16S sequencing

    Measured: Day 1

  10. Number of participants with hookworm infection

    Stool sample analysis DNA extraction for qPCR and 16S sequencing

    Measured: Day 1

  11. Number of participants with Strongyloides infection

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

    Measured: Day 1

  12. Number of participants with Trichuris infection

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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start1 Jun 2021
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813328
Sponsor's protocol ID
SARS-CoV-2/helminth
Status last verified
Dec 2025
First submitted
22 Mar 2021
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38913614

  • Dasan B, Rajamanickam A, Pandiarajan AN, Shanmugam S, Nott S, Babu S. Immunological mechanisms of tuberculosis susceptibility in TB-infected individuals with type 2 diabetes mellitus: insights from mycobacterial growth inhibition assay and cytokine analysis. Microbiol Spectr. 2025 Jan 7;13(1):e0144524. doi: 10.1128/spectrum.01445-24. Epub 2024 Dec 10.

    PubMed 39656000

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with helminth infections (time frame: Day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04813328, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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