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

N/AActive Not RecruitingNCT04813328

National Institute of Allergy and Infectious Diseases (NIAID)1,500 enrolled

Overview

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.

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

1,500

Conditions

COVID-19

Eligibility

Sex: ALLMin age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

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

Chennai, Tamil Nadu, India

Outcomes

Primary Outcomes

Number of participants with helminth infections

Measured by qPCR diagnostics of stool DNA extraction

Time frame: Day 1

Number of participants with SARS-CoV-2 antibodies

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

Time frame: Day 1

Number of participants with positive malaria test

Measured by fingerprick blood samples

Time frame: Day 1

Average Differential blood count

Measured from venipuncture blood samples

Time frame: Day 1

Average Hematocrit levels

Measured from venipuncture blood samples

Time frame: Day 1

Number of participants with latent tuberculosis infection

Measured by IFN-γ release assay

Time frame: Day 1

Number of participants with Wuchereria bancrofti infection

Measured by enzyme-linked immunosorbent assay (ELISA)

Time frame: Day 1

Number of participants with Strongyloides stercoralis infection

Measured by enzyme-linked immunosorbent assay (ELISA)

Time frame: Day 1

Number of participants with Ascaris infection

Stool sample analysis DNA extraction for qPCR and 16S sequencing

Time frame: Day 1

Data from ClinicalTrials.gov

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