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

Recruiting

• Conditions: COVID-19

• Registration Number: NCT04813328
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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 Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-06-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Able to provide informed consent.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with helminth infections	Day 1	Measured by qPCR diagnostics of stool DNA extraction
Number of participants with positive malaria test	Day 1	Measured by fingerprick blood samples
Average Differential blood count	Day 1	Measured from venipuncture blood samples
Average Hematocrit levels	Day 1	Measured from venipuncture blood samples
Number of participants with latent tuberculosis infection	Day 1	Measured by IFN-γ release assay
Number of participants with SARS-CoV-2 antibodies	Day 1	Measured by real-time qPCR (quantitative polymerase chain reaction) assay
Number of participants with Wuchereria bancrofti infection	Day 1	Measured by enzyme-linked immunosorbent assay (ELISA)
Number of participants with Ascaris infection	Day 1	Stool sample analysis DNA extraction for qPCR and 16S sequencing
Number of participants with Strongyloides infection	Day 1	Stool sample analysis using Baermann technique, DNA extraction for qPCR and 16S sequencing
Number of participants with Strongyloides stercoralis infection	Day 1	Measured by enzyme-linked immunosorbent assay (ELISA)
Number of participants with hookworm infection	Day 1	Stool sample analysis DNA extraction for qPCR and 16S sequencing
Number of participants with Trichuris infection	Day 1	Stool sample analysis using DNA extraction for qPCR and 16S sequencing

Trial Locations

Locations (1)

National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER); 🇮🇳 Chennai, Tamilnadu, India