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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• India
  • Tamilnadu
    • Chennai, Tamilnadu, India
      • Recruiting
      • National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER)
      • Contact: Subash Babu, MBBS, PhD; Phone Number: 044-28369711; Email: sbabu@icerindia.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: P'ng Loke, PhD, National Institutes of Health (NIH); Principal Investigator: Subash Babu, MBBS, PhD, National Institute for Research in Tuberculosis

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Parasitic Diseases; COVID-19; Helminthiasis
• Other Study ID Numbers: SARS-CoV-2/helminth

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No