Status:
COMPLETED
TekiTrust Tests to Determine the Level of SARS-COV-2/COVID-19 Neutralizing Antibodies in the Blood
Lead Sponsor:
MiCo BioMed Co., Ltd.
Collaborating Sponsors:
Syntactx
Conditions:
SARS-CoV2 Infection
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine if the TekiTrust Enzyme-Linked Immunosorbent Assay (ELISA) Kit and TekiTrust Rapid Test can accurately determine the amount of antibodies to fight the COVID-1...
Detailed Description
Participants who have been previously diagnosed with COVID-19 within the past 3 months through any FDA emergency use approved (EUA) assay test will eligible for inclusion in the study. A blood and fin...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Able and willing to provide written informed consent
- Previously diagnosed as SARS-CoV-2 positive by any FDA EUA approved assay with a symptom onset date within the previous 30 days and who are willing to provide a nasopharyngeal swab for RT-PCR testing
- Suspected of previous SARS-CoV-2 infection and willing to provide a nasopharyngeal swab for RT-PCR testing
- Previously diagnosed as SARS-CoV-2 positive by a FDA EUA approved RT-PCR assay with a symptom onset date greater than 30 days and a known date of PCR sample collection and symptom severity
Exclusion
- 1\. Any significant medical, psychological, or social condition which in the opinion of the investigator may preclude the subject from participating in the trial
Key Trial Info
Start Date :
June 2 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT05338762
Start Date
June 2 2021
End Date
August 3 2022
Last Update
August 11 2022
Active Locations (5)
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1
Mississippi State University
Starkville, Mississippi, United States, 39762
2
Joy Internal Medicine
Englewood Cliffs, New Jersey, United States, 07632
3
WellNow Urgent Care
Cincinnati, Ohio, United States, 45215
4
WellNow Urgent Care
Columbus, Ohio, United States, 43214