Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)

Stopped early

Conditions studied: Covid19

In brief

This clinical study is designed to test the efficacy of the Novir 2019-nCoV Immunoglobulin M/Immunoglobulin G Antibody Test in a point-of-care setting to support the increasing need for rapid screening in the detection of antibodies. The study is performed on individuals who have no history of COVID-19 and no history of COVID immunization as well as individuals with history of COVID-19 that was diagnosed greater than 15 days. This is performed both through 3mL venous whole blood which is ran through an assay as well a point-of-care rapid test which is resulted in 10 minutes. Aiding in the rapid detection of COVID-19 antibodies.

Key facts

Study ID

NCT04902911

Run by

Medical College of Wisconsin

People needed

91

Starts

2021-04-13

Expected to finish

2022-08-17

Last updated by the study team

2024-01-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must be 21 years old or older.
• Must be able to provide finger stick and venous whole blood samples.
• Must be able to understand and sign a consent form.
• Must be able to provide an additional sample(s) required by the study site for an additional FDA EUA authorized antibody testing (ELISA, CMIA, or other antibody test).
• Has an immediate need to determine COVID-19 status for occupational purposes.
• Was exposed to a COVID-19 patient within 7 days that leads the healthcare provider to suspect the individual of possibly having SARS-CoV-2 infection.
• Has symptoms that lead the healthcare provider to suspect the individual of possibly having SARS-CoV-2 infection.
• Has had a positive FDA EUA authorized PCR test between 1-28 days with or without symptom expression.
• Individuals who have tested positive for COVID-19 infection and have antibodies detected must have agreed to participate in the MCW Tissue Bank COVID-19 banking project.

You may not qualify if…

• Is receiving treatment with infusion of convalescent plasma or other antibody therapy related to SARS-CoV-2 infections.
• Tested negative for COVID-19 by PCR more than 7 days ago.
• Is participating in a SARS-CoV-2 vaccine study.or received any doses of the available SARS-CoV-2 vaccines.
• Previously tested positive for COVID-19 at any point in time (for asymptomatic patients enrolling in the negative patient population).

Where it is running

• Froedtert Health WAC — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.