NCT05584176

COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation

Completed NA Results posted Last updated 1 June 2023

What this trial tests

NA trial testing iCura COVID-19 Antigen Rapid Home Test in SARS-CoV2 Infection in 332 participants. Completed in 21 January 2022.

Timeline

9 December 2021

Primary endpoint
21 January 2022

21 January 2022

Quick facts

Lead sponsor	MP Biomedicals, LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	332
Start date	9 December 2021
Primary completion	21 January 2022
Estimated completion	21 January 2022
Sites	4 locations across United States

Drugs / interventions tested

• iCura COVID-19 Antigen Rapid Home Test
• RT-PCR Test

Conditions studied

• SARS-CoV2 Infection — all drugs for SARS-CoV2 Infection →
• COVID-19 — all drugs for COVID-19 →

Sponsor

MP Biomedicals, LLC

Who can join

2 and older, any sex, with SARS-CoV2 Infection or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Positive Percent Agreement Primary · One hour

The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to eighty percent in a comparison between the Rapid SARS-CoV-2 Antigen Test and RT-PCR comparator test results. The PPA was defined as the proportion of true positive tests, defined by a concordant candidate and comparator test result of positive, out of all positive candidate test results.

Group	Value	95% CI
Subject 14-65+ Years of Age	53
At Least 30 Children Between 2 and 13 Years of Age	2

Negative Percent Agreement Primary · One hour

The acceptance criteria for this study is Negative Percent Agreement (NPA) greater than or equal to ninety-eight percent in a comparison between the Rapid SARS-CoV-2 Antigen Test and RT-PCR comparator test results. The NPA was defined as the proportion of true negative tests, defined by a concordant candidate and comparator test result of negative, out of all negative candidate test results.

Group	Value	95% CI
Subject 14-65+ Years of Age	123
At Least 30 Children Between 2 and 13 Years of Age	10

Detection of Asymptomatic Positives Secondary · One hour

Number of participants with a positive PCR comparator result, but reported no symptoms or epidemiological reasons to suspect COVID-19 infection within the past 14 days. This will be compared to their Rapid SARS-CoV-2 Antigen Test result to determine the ability of the Rapid SARS-CoV-2 Antigen Test to detect individuals who are infected but are not symptomatic.

Group	Value	95% CI
Subject 14-65+ Years of Age	3
At Least 30 Children Between 2 and 13 Years of Age	0

Sponsor's own description

SARS-CoV-2 rapid antigen over the counter clinical performance evaluation

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.