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NCT04542980 Clinical Trial

Qualitative Evaluation of Tear Fluid and Blood for Auto Antibodies Produced in Response to COVID-19

Covid19 Clinical Trial

Official title:
Qualitative Evaluation of Tear Fluid and Blood for IgM and IgG Produced in Response to SARS-CoV2, the Virus Responsible for COVID-19.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04542980
Other study ID # CVDTRS001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date December 31, 2020

Study information
Verified date September 2020
Source Namida Lab
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study objective is to collect tear and blood samples from individuals with positive SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral antigens and autoantibodies.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 18 years of age or older Has been tested for SARS-CoV2 and awaiting results Sample collection for SARS-CoV2 testing Tested positive for SARS-CoV2 virus (confirmed by RT-PCR) prior to enrollment Exclusion Criteria: - Under 18 years of age Concurrent eye infection or trauma unrelated to presence of SARS-CoV2 virus. Advanced COVID-19 state what would preclude safe and feasible sample collection.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• SARS-CoV2 Autoantibody detection
Through the data collected from this study we hope to support the development of an ELISA assay for the detection of IgM and IgG autoantibodies produced in response to the presence of SARS-CoV2

Locations
Country Name City State
United States Namida Lab Fayetteville Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Namida Lab

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Qualitative assessment of IgM and/or IgG by indirect ELISA assay. Determination of the presence or absence of IgM and/or IgG autoantibodies in response to SARS-CoV2 infection. In the case of presence, concentration may be determined as well. through study completion, up to 8 months
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