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
| 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 |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| India | National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER) | Chennai | Tamilnadu |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) |
India,
| 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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