SARS-CoV-2 InfectionNCT05555030
COVID-19 iCura SARS-CoV-2 Ag OTC: Clinical Evaluation
A study testing iCura COVID-19 Antigen Rapid Home Test and RT-PCR Test in people with SARS-CoV-2 Infection and COVID-19, run by New Day Diagnostics at 2 sites in United States.
Trial summary
SARS-CoV-2 rapid antigen over the counter clinical performance evaluation. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19
- What is being tested?
- iCura COVID-19 Antigen Rapid Home Test and RT-PCR Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Lay subjects greater than 2 years old that do not know their current COVID-19 status and can complete the consent/assent process in both written and spoken English may be included in the study.
Who cannot join
- Subjects less than 2 years old will be excluded.
- Participants that are or were medial and/or laboratory professionals will be excluded.
- Participants that cannot read and understand English will be excluded.
- High risk individuals will not be excluded unless they are too young or have prior training or experience that would exclude them.
- Participants who refuse to sign the informed consent/assent form(s) will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Paragon
Anaheim, California, 92703
EDP Biotech
Knoxville, Tennessee, 37919
About this study
Official title: iCura Diagnostics, LLC / COVID-19 Antigen Rapid Home Test Over the Counter Rapid Antigen Self-Test for Detection of SARS-CoV-2 Virus: Clinical Evaluation
SARS-CoV-2 rapid antigen over the counter clinical performance evaluation.
Read the detailed description
Coronavirus disease (COVID-19) is a disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. The SARS-CoV-2 is a β-coronavirus, which is enveloped non-segmented positive-sense RNA virus 22. It is spread by human-to-human transmission via droplets or direct contact, and infection has been estimated to have mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough. On 11 March 2020, the COVID-19 outbreak was characterized as a pandemic by the WHO. Since then, over 70 million people worldwide have been infected with the virus with over 1.5 million deaths attributed to the virus5. Laboratory testing for SARS-CoV-2 is currently being performed to determine if an individual has active infection via detection of viral RNA or if an individual has an immune response to the virus from a previous infection via detection of antibodies.
Specimen collection is a crucial first step in the evaluation of an individual's SARS-CoV-2 infection status. The goal of this project is to evaluate a Candidate Ag self-test kit for over the counter (OTC) use. Study subjects under EDP supervision, either in-person or via video conference, will collect and test anterior nasal swab samples and a Study Representative will collect and ship a nasopharyngeal swab sample for comparator PCR testing. The Candidate Ag self-test kit collection and testing methodology is viewed as a convenient and inexpensive method to test clinical specimens for SARS-CoV-2 and OTC access will improve the availability of COVD-19 testing.
The iCura COVID-19 Antigen Rapid Home Test (candidate test) is a rapid antigen (Ag) immunochromatography based one step in vitro test intended to detect nucleocapsid antigen from the SARS-CoV-2 virus that causes COVID-19. It is designed for over the counter (OTC) rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals within 14 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older.
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Being tested
- iCura COVID-19 Antigen Rapid Home Test, RT-PCR Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TestDiagnostic test
High sensitivity RT-PCR COVID-19 Test
| Study group | Role | What they receive |
|---|---|---|
| At least 30 children between 2 and 13 years of age | Experimental | Participants 2-13 years of age will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test. The parent or legal guardian of the child will collect an anterior nasal swab sample from the child and perform the iCura SARS-CoV-2 Antigen Rapid Home Test. Receives: Device: iCura COVID-19 Antigen Rapid Home Test; Diagnostic Test: RT-PCR Test |
| Subject 14-65+ years of age | Experimental | Participants will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test. The participant will then self-collect or, if both are over 18, collect from another study participant an anterior nasal swab sample and test using the iCura SARS-CoV-2 Antigen Rapid Home Test. Receives: Device: iCura COVID-19 Antigen Rapid Home Test; Diagnostic Test: RT-PCR Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Percent Agreement
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to eighty percent in a comparison between the iCura COVID-19 Antigen Rapid Home TestRT-PCR comparator test results
Measured: 3 months
Negative Percent Agreement
The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to ninety-eight percent in a comparison between the iCura COVID-19 Antigen Rapid Home Test and the RT-PCR comparator test results.
Measured: 3 months
Secondary outcomes (1)
Detection of Asymptomatic Positives
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 iCura COVID-19 Antigen Rapid Home Test result to determine the ability of the iCura COVID-19 Antigen Rapid Home Test to detect individuals who are infected but are not symptomatic.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start4 Aug 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an open-label, prospective study to evaluate the sensitivity and specificity of the iCura COVID-19 Antigen Rapid Home Test when a lay person conducts the test on themselves or another study participant. Potential subjects will be those presenting for COVID-19 testing. The study will evaluate the performance of the iCura COVID-19 Antigen Rapid Home Test by comparing it to a high sensitivity EUA SARS-CoV-2 RT-PCR assay to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity).
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Day Diagnostics
- Sponsor type
- Research network
- Collaborators
- Paragon Rx Clinical, Inc., iCura Diagnostics, LLC
- Responsible party
- Principal investigator, Jason Liggett, New Day Diagnostics
- Investigators
- Jason Liggett, PhD, Principal investigator, New Day Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555030
- Sponsor's protocol ID
- EDP-OTC-iCD-001
- Status last verified
- Feb 2023
- First submitted
- 12 Sep 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
PubMed 32113704Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.
PubMed 32169119Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.
PubMed 32081636
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCura Diagnostics, LLC / COVID-19 Antigen Rapid Home Test Over the Counter Rapid Antigen Self-Test for Detection of SARS-CoV-2 Virus: Clinical Evaluation
- ClinicalTrials.gov ID
- NCT05555030
- Acronym / sponsor ID
- EDP-OTC-iCD-001
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- New Day DiagnosticsResearch network
- Collaborators
- Paragon Rx Clinical, Inc., iCura Diagnostics, LLC
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SARS-CoV-2 rapid antigen over the counter clinical performance evaluation.
Detailed description
Coronavirus disease (COVID-19) is a disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. The SARS-CoV-2 is a β-coronavirus, which is enveloped non-segmented positive-sense RNA virus 22. It is spread by human-to-human transmission via droplets or direct contact, and infection has been estimated to have mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough. On 11 March 2020, the COVID-19 outbreak was characterized as a pandemic by the WHO. Since then, over 70 million people worldwide have been infected with the virus with over 1.5 million deaths attributed to the virus5. Laboratory testing for SARS-CoV-2 is currently being performed to determine if an individual has active infection via detection of viral RNA or if an individual has an immune response to the virus from a previous infection via detection of antibodies.
Specimen collection is a crucial first step in the evaluation of an individual's SARS-CoV-2 infection status. The goal of this project is to evaluate a Candidate Ag self-test kit for over the counter (OTC) use. Study subjects under EDP supervision, either in-person or via video conference, will collect and test anterior nasal swab samples and a Study Representative will collect and ship a nasopharyngeal swab sample for comparator PCR testing. The Candidate Ag self-test kit collection and testing methodology is viewed as a convenient and inexpensive method to test clinical specimens for SARS-CoV-2 and OTC access will improve the availability of COVD-19 testing.
The iCura COVID-19 Antigen Rapid Home Test (candidate test) is a rapid antigen (Ag) immunochromatography based one step in vitro test intended to detect nucleocapsid antigen from the SARS-CoV-2 virus that causes COVID-19. It is designed for over the counter (OTC) rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals within 14 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, prospective study to evaluate the sensitivity and specificity of the iCura COVID-19 Antigen Rapid Home Test when a lay person conducts the test on themselves or another study participant. Potential subjects will be those presenting for COVID-19 testing. The study will evaluate the performance of the iCura COVID-19 Antigen Rapid Home Test by comparing it to a high sensitivity EUA SARS-CoV-2 RT-PCR assay to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity).
| Arm | Type | Receives |
|---|---|---|
| At least 30 children between 2 and 13 years of age | Experimental | Device: iCura COVID-19 Antigen Rapid Home Test, Diagnostic Test: RT-PCR TestParticipants 2-13 years of age will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test. The parent or legal guardian of the child will collect an anterior nasal swab sample from the child and perform the iCura SARS-CoV-2 Antigen Rapid Home Test. |
| Subject 14-65+ years of age | Experimental | Device: iCura COVID-19 Antigen Rapid Home Test, Diagnostic Test: RT-PCR TestParticipants will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the iCura SARS-CoV-2 Antigen Rapid Home Test. The participant will then self-collect or, if both are over 18, collect from another study participant an anterior nasal swab sample and test using the iCura SARS-CoV-2 Antigen Rapid Home Test. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Lay subjects greater than 2 years old that do not know their current COVID-19 status and can complete the consent/assent process in both written and spoken English may be included in the study.
Key exclusion criteria (5 listed)
- Subjects less than 2 years old will be excluded.
- Participants that are or were medial and/or laboratory professionals will be excluded.
- Participants that cannot read and understand English will be excluded.
- High risk individuals will not be excluded unless they are too young or have prior training or experience that would exclude them.
- Participants who refuse to sign the informed consent/assent form(s) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCura COVID-19 Antigen Rapid Home TestCandidate 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. | Device | At least 30 children between 2 and 13 years of age, Subject 14-65+ years of age |
| RT-PCR TestHigh sensitivity RT-PCR COVID-19 Test | Diagnostic test | At least 30 children between 2 and 13 years of age, Subject 14-65+ years of age |
Primary outcome
Positive Percent Agreement
Time frame: 3 months
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to eighty percent in a comparison between the iCura COVID-19 Antigen Rapid Home TestRT-PCR comparator test results
Negative Percent Agreement
Time frame: 3 months
The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to ninety-eight percent in a comparison between the iCura COVID-19 Antigen Rapid Home Test and the RT-PCR comparator test results.
1 secondary outcome
Detection of Asymptomatic Positives
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 32113704Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
- Background: PubMed 32169119Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.
- Background: PubMed 32081636Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.
- WHO. 2022Link provided by the sponsor.
- Johns Hopkins University Center for Health Security Website. 2020Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Liggett, PhD principal investigator
New Day Diagnostics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCura COVID-19 Antigen Rapid Home Test and RT-PCR Test in people with SARS-CoV-2 Infection and COVID-19, run by New Day Diagnostics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Percent Agreement (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555030, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.