CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 332 enrolled
Drug / intervention
iCura COVID-19 Antigen Rapid Home Test +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05584176
NCT05584176N/ACompleted
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Over the Counter Rapid Antigen Test for Detection of SARS-CoV-2 Virus: Clinical Evaluation

MP Biomedicals, LLC·interventional·Posted Oct 18, 2022·Updated Jun 1, 2023

In Brief

A clinical study evaluating iCura COVID-19 Antigen Rapid Home Test and RT-PCR Test for SARS-CoV2 Infection and COVID-19. Completed, enrolled 332 participants across 4 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV2 Infection, COVID-19
CountriesUnited States
CollaboratorsNew Day Diagnostics

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 18, 2022
Enrollment StartDec 9, 2021
Primary CompletionJan 21, 2022
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 3.7 years ago

Interventions

iCura COVID-19 Antigen Rapid Home Testdevice

Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person. Comparator NP samples shall be collected at least 15 minutes prior to Ag samples with at least 15 minutes between nasal collections including collections that may occur prior to study enrollment. Comparator samples will be collected first by qualified personnel at a study site or physician's office using an FDA authorized nasopharyngeal swab collection kit and SARS-CoV-2 molecular assay.

RT-PCR Testdevice

High sensitivity RT-PCR COVID-19 Test