SARS-CoV-2NCT04808921
Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test
A study testing Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test in people with SARS-CoV-2 and Covid-19, run by Sky Medical Supplies & Equipments, LLC at 1 site in United States.
Trial summary
The SARS-CoV-2 Antigen Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the SARS-CoV-2 Antigen Rapid Test assay will be assessed by comparison to a reference method. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2, Covid-19, Coronavirus
- What is being tested?
- Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2021to 28 Jan 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Up to 200 subjects will be screened, consented, and enrolled to obtain a minimum of 60 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of informed consent
- Subject is a 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 14 days prior to onset of symptoms.
- Subject is an appropriate candidate for Nasopharyngeal sample collection. d/. Subject is willing to provide nasopharyngeal swab samples.
- Exclusion Criteria:An individual who meets the following criterion will be excluded from participation in this study:
- 1. 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
D&H National Research Centers INC
Miami, Florida, 33155
About this study
Official title: Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
The SARS-CoV-2 Antigen Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the SARS-CoV-2 Antigen Rapid Test assay will be assessed by comparison to a reference method.
Read the detailed description
The clinical performance of the SARS-CoV-2 Antigen Rapid test was evaluated in a prospective clinical study conducted at a single (1) CLIA waiver investigational site in Miami, Florida, U.S. Consenting patients of any age, gender, or race/ethnicity who presented at the test site with COVID-19 like symptoms during the 2021 COVID-19 season were sequentially enrolled and tested. Five (5) minimally trained operators with little laboratory experience and who received no training on use of the SARS-CoV-2 Antigen Rapid test and were, therefore, representative of the intended users performed the study test evaluations.
A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number.
- Conditions
- SARS-CoV-2, Covid-19, Coronavirus
- Being tested
- Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test
- Keywords
- POC, Antigen
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid TestDiagnostic test
Rapid Antigen diagnostic 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: Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid 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 antigen test compared to PCR using nasopharyngeal swab samples
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start9 Jan 2021
- Primary completion18 Jan 2021
- Study completion28 Jan 2021
Why it stopped: As of 11 Oct 2021, IRB oversight for site is terminated. We no longer have IRB Approval to conduct this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sky Medical Supplies & Equipments, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge P Amaya, M.D, Principal investigator, D&H National Research Centers INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808921
- Sponsor's protocol ID
- SKYCOV001
- Status last verified
- Aug 2022
- First submitted
- 18 Mar 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
- ClinicalTrials.gov ID
- NCT04808921
- Acronym / sponsor ID
- SKYCOV001
- Conditions
- SARS-CoV-2, Covid-19, Coronavirus
- Keywords
- POC, Antigen
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As of 11 Oct 2021, IRB oversight for site is terminated. We no longer have IRB Approval to conduct this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sky Medical Supplies & Equipments, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 22 Mar 2021 (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.
The SARS-CoV-2 Antigen Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the SARS-CoV-2 Antigen Rapid Test assay will be assessed by comparison to a reference method.
Detailed description
The clinical performance of the SARS-CoV-2 Antigen Rapid test was evaluated in a prospective clinical study conducted at a single (1) CLIA waiver investigational site in Miami, Florida, U.S. Consenting patients of any age, gender, or race/ethnicity who presented at the test site with COVID-19 like symptoms during the 2021 COVID-19 season were sequentially enrolled and tested. Five (5) minimally trained operators with little laboratory experience and who received no training on use of the SARS-CoV-2 Antigen Rapid test and were, therefore, representative of the intended users performed the study test evaluations.
A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number.
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: Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid 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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Up to 200 subjects will be screened, consented, and enrolled to obtain a minimum of 60 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of informed consent
- Subject is a 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 14 days prior to onset of symptoms.
- Subject is an appropriate candidate for Nasopharyngeal sample collection. d/. Subject is willing to provide nasopharyngeal swab samples.
- Exclusion Criteria:An individual who meets the following criterion will be excluded from participation in this study:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid TestRapid Antigen diagnostic 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: 30 days
Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- 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.
Jorge P Amaya, M.D principal investigator
D&H National Research Centers INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test in people with SARS-CoV-2 and Covid-19, 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 6 inclusion and 0 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: withdrawn, as of the sponsor's last update on 5 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent Positive Agreement and Negative Percent Agreement (time frame: 30 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 5 Aug 2022.