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

Completed

• Conditions: SARS-CoV 2 Infection; Covid19

• Registration Number: NCT04542980
• Lead Sponsor: Namida Lab

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-13
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2020-09-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative assessment of IgM and/or IgG by indirect ELISA assay.	through study completion, up to 8 months	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.

Trial Locations

Locations (1)

Namida Lab; 🇺🇸 Fayetteville, Arkansas, United States