Qualitative Evaluation of Tear Fluid and Blood for Auto Antibodies Produced in Response to COVID-19
1 other identifier
observational
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 21, 2022
September 1, 2020
4 months
April 13, 2020
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Control
Control tear and serum samples will be selected from Namida Lab's own biorepository.
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Namida Lablead
Study Sites (1)
Namida Lab
Fayetteville, Arkansas, 72703, United States
Biospecimen
Tears and Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2020
First Posted
September 9, 2020
Study Start
September 15, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 21, 2022
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Access Criteria
- Supporting information can be obtained by making a request to the central study contact.