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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |