NCT04699903|CompletedFDA Device
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Sponsor study identifier
observational
201
1 country
3
Study Start
January 5, 2021
Actual (reported)Primary Completion
January 29, 2021
Actual (reported)Study Completion
April 9, 2021
Actual (reported)Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 9, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 29, 2020
Actual (reported)January 5, 2021
Actual (reported)January 7, 2021
Actual (reported)January 29, 2021
Actual (reported)April 9, 2021
Actual (reported)PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR
Determine PPA and NPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
0-7 days
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
8-14 days
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
15 - 90 days
Positive diagnosis of COVID-19 confirmed by a positive EUA SARS-CoV-2 PCR will be stratified in three subgroups 0 - 7 days since onset of symptoms 8 - 14 days since onset of symptoms 15 -90 days since onset of symptoms
Negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort.
All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients in the outpatient setting with EUA PCR test results who meet inclusion and exclusion criteria are eligible for the study.
Benchmark - SoCal
Colton, California, 92324, United States
Comprehensive Clinical Research
West Palm Beach, Florida, 33409, United States
Great Lakes Clinical Trials (GLCT)
Chicago, Illinois, 60640, United States
Fingerstick whole blood
201 participants (actual enrollment reported by the registry).
First Submitted
December 29, 2020
First Posted
January 7, 2021
Study Start
January 5, 2021
Actual (reported)The Safety and Immunogenicity of a DNA-based Vaccine (COVIGEN) in Healthy Volunteers
Contact the study team to confirm eligibility.
Primary Completion
January 29, 2021
Actual (reported)Study Completion
April 9, 2021
Actual (reported)Last Updated
June 18, 2021
Record last verified: 2021-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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