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NCT04813328 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04813328
Other study ID # SARS-CoV-2/helminth
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date April 2024

Study information
Verified date July 2023
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
India National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER) Chennai Tamilnadu

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

India, 

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