SARS-CoVEasyCovNCT04583319
Validation of a Rapid, Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 (COVID-19) Infection
An observational study of SARS-CoV, run by Firalis SA at 1 site in Turkey (Türkiye).
Trial summary
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs \& saliva samples). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV
- What is being tested?
- EasyCov POC
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2020to 30 Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will be carried out on patients suspected to have contracted COVID-19 and to be screened by RT-PCR test, according to decision of her/his physician. These patients are routinely screened by a Turkish MOH and FDA approved RT-PCR test for COVID-19 and will be allocated to SARS-COV-2 Positive or Control group based on results obtained from RT-PCR.
Who may be able to join
- Non-specific inclusion criteria:
- Participant aged 18 and above
- Participant agreeing to follow the study procedures
- Participant able to understand the purpose, nature and methodology of the study
- Participant having signed the informed consent
- Specific inclusion criteria:
Show all 9Show fewer
- SARS-COV-2 positive patients - Participants tested positive for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.
- SARS-COV-2 negative controls
- Participants tested negative for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.
Who cannot join
- Minors, persons deprived of their liberty, protected adults or vulnerable persons.
- Refusal to sign the consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine (ITF)
Istanbul
About this study
Official title: A Prospective, Non-interventional Study for Validation of a Rapid, Non-invasive IVD as a Point-of-care Test for Diagnosis of SARS-COV-2 Infection
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs \& saliva samples).
Read the detailed description
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs \& saliva samples).
The operators performing the diagnostic tests will be blinded from the RT-PCR results (i.e. participant's group will be anonymized). Participants who have been tested by an routineTurkish MOH and FDA EUA approved RT-PCR test using nasopharyngeal swabs will be included in the study to perform the EASYCOV IVD tests in a POC setting.
Primary Objective:
- To evaluate the performance of EasyCov IVD as a point-of-care (POC) test performed on saliva samples for the diagnosis of SARS-CoV-2 infection by comparing it to a Turkish MOH and FDA EUA approved RT-PCR test performed on nasopharyngeal samples.
Secondary Objectives:
- Collection and storage of saliva samples, nasopharyngeal swabs at D0 to perform future COVID-19 related research projects and validation of future generations of EASYCOV assays as well as exploratory studies to find candidate biomarkers for Covid-19.
160 participants will be included in 1:1 ratio: 80 SARS-CoV-2 positive and 80 SARS-CoV-2 negative by a Turkish MOH and FDA approved RT-PCR IVD test
- Conditions
- SARS-CoV
- Being tested
- EasyCov POC
- Keywords
- SARS Coronavirus, Coronavirus, Covid-19
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EasyCov POCDiagnostic test
Saliva samples will be collected according to the sampling protocol defined each for EASYCOV test. The EasyCoV test will be performed at the beginning of the study before obtaining the routine RT- PCR test results. The operators performing this test will be blinded from the routine RT-PCR results.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Positive | patients tested positive for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test. Receives: Diagnostic Test: EasyCov POC | |
| SARS-CoV-2 Negative | participants tested negative for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test. Receives: Diagnostic Test: EasyCov POC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive percent agreement (PPA)
A positive percent agreement (PPA) of EASYCOV PoC assay will be corroborated with the routine Turkish MOH and FDA approved reference method RT-PCR using nasopharyngeal samples.
Measured: 1 month
Secondary outcomes (1)
Performance
The performance (accuracy, sensitivity, specificity, positive predictive value, negative predictive value) of EASYCOV POC assay will be evaluated compared to the routine Turkish MOH and FDA approved RT-PCR method using nasopharyngeal samples.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start12 Dec 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoVStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firalis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Istanbul University
- Responsible party
- Sponsor
- Investigators
- Arif Atahan, Prof.MD, Principal investigator, Istanbul University Istanbul Faculty of Medicine (ITF), Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583319
- Sponsor's protocol ID
- ST0194
- Acronym
- EasyCov
- Status last verified
- May 2024
- First submitted
- 30 Sep 2020
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional Study for Validation of a Rapid, Non-invasive IVD as a Point-of-care Test for Diagnosis of SARS-COV-2 Infection
- ClinicalTrials.gov ID
- NCT04583319
- Acronym / sponsor ID
- EasyCov / ST0194
- Conditions
- SARS-CoV
- Keywords
- SARS Coronavirus, Coronavirus, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Firalis SAIndustry (pharma, biotech, devices)
- Collaborators
- Istanbul University
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 12 Oct 2020 (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.
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs \& saliva samples).
Detailed description
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs \& saliva samples).
The operators performing the diagnostic tests will be blinded from the RT-PCR results (i.e. participant's group will be anonymized). Participants who have been tested by an routineTurkish MOH and FDA EUA approved RT-PCR test using nasopharyngeal swabs will be included in the study to perform the EASYCOV IVD tests in a POC setting.
Primary Objective:
- To evaluate the performance of EasyCov IVD as a point-of-care (POC) test performed on saliva samples for the diagnosis of SARS-CoV-2 infection by comparing it to a Turkish MOH and FDA EUA approved RT-PCR test performed on nasopharyngeal samples.
Secondary Objectives:
- Collection and storage of saliva samples, nasopharyngeal swabs at D0 to perform future COVID-19 related research projects and validation of future generations of EASYCOV assays as well as exploratory studies to find candidate biomarkers for Covid-19.
160 participants will be included in 1:1 ratio: 80 SARS-CoV-2 positive and 80 SARS-CoV-2 negative by a Turkish MOH and FDA approved RT-PCR IVD test
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Positive | – | Diagnostic Test: EasyCov POCpatients tested positive for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test. |
| SARS-CoV-2 Negative | – | Diagnostic Test: EasyCov POCparticipants tested negative for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be carried out on patients suspected to have contracted COVID-19 and to be screened by RT-PCR test, according to decision of her/his physician. These patients are routinely screened by a Turkish MOH and FDA approved RT-PCR test for COVID-19 and will be allocated to SARS-COV-2 Positive or Control group based on results obtained from RT-PCR.
Key inclusion criteria (9 listed)
- Participant aged 18 and above
- Participant agreeing to follow the study procedures
- Participant able to understand the purpose, nature and methodology of the study
- Participant having signed the informed consent
- SARS-COV-2 positive patients - Participants tested positive for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.
Key exclusion criteria (2 listed)
- Minors, persons deprived of their liberty, protected adults or vulnerable persons.
- Refusal to sign the consent.
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 |
|---|---|---|
| EasyCov POCSaliva samples will be collected according to the sampling protocol defined each for EASYCOV test. The EasyCoV test will be performed at the beginning of the study before obtaining the routine RT- PCR test results. The operators performing this test will be blinded from the routine RT-PCR results. | Diagnostic test | SARS-CoV-2 Negative, SARS-CoV-2 Positive |
Primary outcome
Positive percent agreement (PPA)
Time frame: 1 month
A positive percent agreement (PPA) of EASYCOV PoC assay will be corroborated with the routine Turkish MOH and FDA approved reference method RT-PCR using nasopharyngeal samples.
1 secondary outcome
Performance
Time frame: 1 month
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 23 May 2024.
- 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.
Arif Atahan, Prof.MD principal investigator
Istanbul University Istanbul Faculty of Medicine (ITF), Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV, run by Firalis SA at 1 site in Turkey (Türkiye).
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 9 inclusion and 2 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 23 May 2024. 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 Turkey (Türkiye). 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 (PPA) (time frame: 1 month). 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 23 May 2024.