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

• Sponsor: Namida Lab (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04542980
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV 2 Infection; Covid19	Diagnostic Test: SARS-CoV2 Autoantibody detection

Study Design

• Study Type: Observational
• Actual Enrollment: 44 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• 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.
• Actual Study Start Date: Sep 15, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Namida Lab	Fayetteville	Arkansas	United States	72703

Sponsors and Collaborators

• Namida Lab

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Namida Lab
• ClinicalTrials.gov Identifier: NCT04542980
• Other Study ID Numbers: CVDTRS001
• First Posted: Sep 9, 2020
• Last Update Posted: Mar 21, 2022
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Autoantibodies

Study Results

No Results Posted as of Mar 21, 2022