NCT04699903

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

24 days

First QC Date

December 29, 2020

Last Update Submit

June 15, 2021

Conditions

SARS-Cov-2, Covid19

Keywords

IgGPoint of care testingEUA

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Positive SARS-Cov-2 cohort

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

Diagnostic Test: POC SARS-Cov-2 IgG Antibody test

Negative SARS-Cov-2 cohort

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.

Diagnostic Test: POC SARS-Cov-2 IgG Antibody test

Interventions

POC SARS-Cov-2 IgG Antibody testDIAGNOSTIC_TEST

All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood

Negative SARS-Cov-2 cohortPositive SARS-Cov-2 cohort

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the outpatient setting with EUA PCR test results who meet inclusion and exclusion criteria are eligible for the study.

You may qualify if:

  • Patients with high-sensitive EUA PCR results (positive result)
  • Previous diagnostic of SARS-Cov-2
  • Signed informed consent

You may not qualify if:

  • Missing PCR results
  • Results from a non-high-sensitive PCR test
  • Negative Cohort
  • Patients with high-sensitive EUA PCR results (negative result)
  • Signed informed consent
  • Missing PCR results
  • Results from a non-high-sensitive PCR test
  • Previous diagnostic of SARS-Cov-2
  • History of a positive SARS-CoV-2 antibody test (IgG, IgM or Total Antibody)
  • Negative SARS-Cov-2 PCR result that occurred \> 7 days from study visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Benchmark - SoCal

Colton, California, 92324, United States

Location

Comprehensive Clinical Research

West Palm Beach, Florida, 33409, United States

Location

Great Lakes Clinical Trials (GLCT)

Chicago, Illinois, 60640, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fingerstick whole blood

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2020

First Posted

January 7, 2021

Study Start

January 5, 2021

Primary Completion

January 29, 2021

Study Completion

April 9, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

US(3)