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NCT04902911 · ClinicalTrials.gov registry record
Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)
A clinical trial, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- 91
- Enrollment target
NCT04902911: Clinical Trial study, sponsored by Medical College of Wisconsin.
NCT04902911 is a clinical trial that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 91 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04902911 was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- 91 participants
- Enrollment target
Study Summary
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.
Primary Outcome
To determine the sensitivity and specificity of the Novir 2019-nCoV IgM/IgG Antibody Test (Colloidal Gold) when testing intended use populations who meet the criteria of having COVID-19 infection by Centers for Disease Control and Prevention (CDC). The test is to be performed by healthcare professionals (non-CLIA laboratory technicians) at POC settings.vStandard calculations will be used to derive sensitivity, specificity, positive and negative predictive values as well as 95% confidence interva
Interventions
- DEVICE COVID-19 SARS-CoV IgG/IgM antibody rapid test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2022-08-17 |
Why NCT04902911 stopped before completion
NCT04902911 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 91 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which COVID-19 SARS-CoV IgG/IgM antibody rapid test is the first listed.
NCT04902911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04902911 about?
NCT04902911 is a clinical study titled "Point of Care Evaluation of Novir 2019-nCoV Immunoglobulin G/ Immunoglobulin M (IgG/IgM) Antibody Test (Collodial Gold)". 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...
What is the current status of trial NCT04902911?
This trial is currently terminated. The enrollment target is 91 participants. The study started on 2021-04-13. Estimated completion is 2022-08-17.
What interventions are being tested in trial NCT04902911?
The interventions under investigation include: COVID-19 SARS-CoV IgG/IgM antibody rapid test (DEVICE).
Who is sponsoring clinical trial NCT04902911?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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