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

NCT ID: NCT04542980

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV 2 Infection Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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SARS-CoV2 Positive

Tear Samples: Tear samples will be collected from 100 patients who have tested positive for the SARS-CoV2 virus.

A total of 100 Blood samples will be drawn using standard phlebotomy techniques for venipuncture from patients who have tested positive for the SARS-CoV2 virus.

SARS-CoV2 Autoantibody detection

Intervention Type DIAGNOSTIC_TEST

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

Control

Control tear and serum samples will be selected from Namida Lab's own biorepository.

No interventions assigned to this group

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Namida Lab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Namida Lab

Fayetteville, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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CVDTRS001

Identifier Type: -

Identifier Source: org_study_id

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