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

March 7, 2022 updated by: Namida Lab

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Namida Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants will be recruited from hospital and health care settings testing and/or treating individuals for the presence of the SARS-CoV2 virus and resulting COVID-19 disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative assessment of IgM and/or IgG by indirect ELISA assay.
Time Frame: 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.
through study completion, up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namida Lab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVDTRS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Access Criteria

Supporting information can be obtained by making a request to the central study contact.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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