COVID-19NCT05491993
This Trial is a Clinical Performance Validation Study That Will Evaluate the Clinical Agreement of the Sky Medical™ Rapid Antigen Test Comparing the Antigen Rapid Test to RT-PCR
A study testing Sky Medical™ Rapid Antigen Test in people with COVID-19 and Sars-CoV-2 Infection, run by Sky Medical Supplies & Equipments, LLC at 1 site in United States.
Trial summary
Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- COVID-19, Sars-CoV-2 Infection
- What is being tested?
- Sky Medical™ Rapid Antigen Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 11 Jan 2023
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of informed consent.
- Subject is suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) AND with no other etiology that fully explains the clinical presentation, with or without a history of close contact with a confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms.
- Subject is an appropriate candidate for Nasopharyngeal sample collection.
- Subject is willing to provide Nasopharyngeal samples.
Who cannot join
- Individuals who present with 10 or greater days of Covid-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post- defervescence and/or convalescence.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
American Research Labs
Lake Worth, Florida, 33462
Sri Madireddy, PhD, 561-801-5835, sri@celestamedical.com
Sri Madireddy, PhD
About this study
Official title: Clinical Evaluation of the Sky Medical™ Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.
Read the detailed description
Clinical performance characteristics of the Sky Medical™SARS-CoV-2 Antigen Rapid test was compared to a Reference Extracted EUA SARS-CoV-2 RT-PCR. The test kit was evaluated in the U.S in which patients were sequentially enrolled and tested. Symptomatic subjects were enrolled within six days of the onset of symptoms from a multi-site prospective clinical study. A total of 69 Nasopharyngeal samples, were tested in one (1) CLIA waived investigational site by five (5) minimally trained operators in the U.S during the 2022 COVID-19 season.
NP swab specimens collected from the patients with COVID-19 like symptoms in the U.S during the 2022 COVID-19 season and stored in BD universal transport media tube were provided by our site in the U.S. All the NP swab specimens were confirmed as positive or negative and validated with Ct value by the FDA EUA RT-PCR as a comparator method prior to the study. A total of 69 samples consisting of 39 confirmed positive nasopharyngeal (NP) swabs, 30 confirmed negative NP swab specimens were collected. The specimens were aliquoted, randomized, and blinded into sample panels that were tested by each operator, using the instructions provided by the Quick Reference Instructions (QRI).
All the study samples were randomized and assigned with a unique study subject ID by the sponsor prior to testing at the study site. The expected results of the samples were completely blinded to the operators. All the samples were tested by five (5) operators according to the Quick Reference Instructions only.
- Conditions
- COVID-19, Sars-CoV-2 Infection
- Being tested
- Sky Medical™ Rapid Antigen 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.
Sky Medical™ Rapid Antigen TestDiagnostic test
Rapid Antigen Diagnostic Test device performance comparative to RT-PCR.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Antigen Rapid Test | Experimental | The same group of patients participated in two arms of the study. One arm was for obtaining data on the Rapid Antigen Test for Covid-19. The comparator arm was to obtain data from the RT-PCR. Receives: Diagnostic Test: Sky Medical™ Rapid Antigen Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Positive Agreement and Negative Percent Agreement
Calculate the performance of the Rapid Antigen Test compared to PCR using swab samples.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start22 Feb 2022
- Primary completion11 Jan 2023 (estimated)
- Study completion11 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The purpose of this study is to validate the performance of the SARS-CoV-2 Antigen Test bioassay for rapid detection of infection when using a nasopharyngeal swab. A prospective randomized and blinded study to evaluate a rapid point of care bioassay for the detection of virus particles compared with the currently validated RT-PCR detection standard. Nasopharyngeal samples will be collected along with the current standard of care collection.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sky Medical Supplies & Equipments, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sri Madireddy, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491993
- Sponsor's protocol ID
- SKYCOV001-2
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Sky Medical™ Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
- ClinicalTrials.gov ID
- NCT05491993
- Acronym / sponsor ID
- SKYCOV001-2
- Conditions
- COVID-19, Sars-CoV-2 Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sky Medical Supplies & Equipments, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 11 Jan 2023 (estimated)
- Study completion
- 11 Jan 2023 (estimated)
- First posted
- 8 Aug 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.
Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.
Detailed description
Clinical performance characteristics of the Sky Medical™SARS-CoV-2 Antigen Rapid test was compared to a Reference Extracted EUA SARS-CoV-2 RT-PCR. The test kit was evaluated in the U.S in which patients were sequentially enrolled and tested. Symptomatic subjects were enrolled within six days of the onset of symptoms from a multi-site prospective clinical study. A total of 69 Nasopharyngeal samples, were tested in one (1) CLIA waived investigational site by five (5) minimally trained operators in the U.S during the 2022 COVID-19 season.
NP swab specimens collected from the patients with COVID-19 like symptoms in the U.S during the 2022 COVID-19 season and stored in BD universal transport media tube were provided by our site in the U.S. All the NP swab specimens were confirmed as positive or negative and validated with Ct value by the FDA EUA RT-PCR as a comparator method prior to the study. A total of 69 samples consisting of 39 confirmed positive nasopharyngeal (NP) swabs, 30 confirmed negative NP swab specimens were collected. The specimens were aliquoted, randomized, and blinded into sample panels that were tested by each operator, using the instructions provided by the Quick Reference Instructions (QRI).
All the study samples were randomized and assigned with a unique study subject ID by the sponsor prior to testing at the study site. The expected results of the samples were completely blinded to the operators. All the samples were tested by five (5) operators according to the Quick Reference Instructions only.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The purpose of this study is to validate the performance of the SARS-CoV-2 Antigen Test bioassay for rapid detection of infection when using a nasopharyngeal swab. A prospective randomized and blinded study to evaluate a rapid point of care bioassay for the detection of virus particles compared with the currently validated RT-PCR detection standard. Nasopharyngeal samples will be collected along with the current standard of care collection.
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Antigen Rapid Test | Experimental | Diagnostic Test: Sky Medical™ Rapid Antigen TestThe same group of patients participated in two arms of the study. One arm was for obtaining data on the Rapid Antigen Test for Covid-19. The comparator arm was to obtain data from the RT-PCR. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent.
- Subject is suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) AND with no other etiology that fully explains the clinical presentation, with or without a history of close contact with a confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms.
- Subject is an appropriate candidate for Nasopharyngeal sample collection.
- Subject is willing to provide Nasopharyngeal samples.
Key exclusion criteria (1 listed)
- Individuals who present with 10 or greater days of Covid-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post- defervescence and/or convalescence.
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 |
|---|---|---|
| Sky Medical™ Rapid Antigen TestRapid Antigen Diagnostic Test device performance comparative to RT-PCR. | Diagnostic test | SARS-CoV-2 Antigen Rapid Test |
Primary outcome
Percent Positive Agreement and Negative Percent Agreement
Time frame: 90 Days
Calculate the performance of the Rapid Antigen Test compared to PCR using swab samples.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
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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.
Sri Madireddy, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sky Medical™ Rapid Antigen Test in people with COVID-19 and Sars-CoV-2 Infection, run by Sky Medical Supplies & Equipments, LLC at 1 site 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana-Kathryn LaParl ((954)804-3760, MarianaLaParl@skymedical.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Positive Agreement and Negative Percent Agreement (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2022.