NCT04562246

Brief Summary

The primary objective is to assess and validate the ability of the Beckman Coulter Access COVID-19 IgG and IgM assays to detect immunity in COVID-19 patients in the Henry Ford Hospital Health System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 14, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

September 22, 2020

Last Update Submit

February 27, 2024

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Prevalence of antibodies to SARS-CoV-2

    Assessment of prevalence of antibodies to SARS-CoV-2 in subjects tested positive by RT-PCR

    12 months

Study Arms (1)

PCR positive subjects

Patients who receive positive test result from RT-PCR for SARS-CoV-2.

Diagnostic Test: Serologic assays for antibodies to SARS-CoV-2

Interventions

Serologic assays for antibodies to SARS-CoV-2DIAGNOSTIC_TEST

Beckman Coulter and Roche automated immunoassays

PCR positive subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A minimum of 500, but up to 1000 subjects will be enrolled from a retrospective data review and a laboratory information system (LIS) SunQuest identification of COVID-19 (RT-PCR SARS CoV-2) samples.

You may qualify if:

  • Patients ≥18 years of age; COVID-19 by RT-PCR SARS-CoV-2 assay. (Phase I)

You may not qualify if:

  • Subjects who tested for COVID-19, but have no available serum specimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

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
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Chemistry-Pathology

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 24, 2020

Study Start

August 14, 2020

Primary Completion

March 22, 2021

Study Completion

February 26, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

US(1)