Covid19NCT04832828
Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive
An observational study of Covid19, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The presence of the described silent hypoxia in subjects diagnosed with COVID19 highlights the need for valid tools to assess respiratory capacity. The Roth test has been associated with acceptable sensitivity and specificity criteria in patients with previous respiratory pathology; however, its validity in this type… Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Covid19
- What is being tested?
- Roth´s Test
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 28 Nov 2020
- 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 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects aged 18 to 90 years were recruited by non-probabilistic convenience sampling in Primary Health Care Centres of the Primary Health Care Management of SERMAS and the Intensive Care Unit of the University Hospital of Gran Canaria Doctor Negrín of the Canary Health Service
Who may be able to join
- having been diagnosed as COVID-19 positive and with symptoms compatible with Sars-Cov-2 infection in the last 7 days prior to assessment,
- having an understanding of Spanish,
- and having no history of respiratory pathology prior to the current infection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The presence of the described silent hypoxia in subjects diagnosed with COVID19 highlights the need for valid tools to assess respiratory capacity. The Roth test has been associated with acceptable sensitivity and specificity criteria in patients with previous respiratory pathology; however, its validity in this type of patient has not been proven.
- Conditions
- Covid19
- Being tested
- Roth´s 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.
Roth´s TestDiagnostic test
Subjets must count from 1 to 30 in their languages, and health professional will count seconds that last in take breath during the count.
| Study group | Role | What they receive |
|---|---|---|
| COVID+ Group | Patients diagnosed with Covid19 positive in last 7 days Receives: Diagnostic Test: Roth´s Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation
The pulseoximeter percentage value
Measured: 12 weeks
Secondary outcomes (1)
Roth´s test
The level described in the test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Jun 2020
- Primary completion28 Nov 2020
- Study completion28 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 only
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raúl Ferrer-Peña, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832828
- Sponsor's protocol ID
- PI-4321
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive
- ClinicalTrials.gov ID
- NCT04832828
- Acronym / sponsor ID
- PI-4321
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 28 Nov 2020 (actual)
- First posted
- 6 Apr 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 presence of the described silent hypoxia in subjects diagnosed with COVID19 highlights the need for valid tools to assess respiratory capacity. The Roth test has been associated with acceptable sensitivity and specificity criteria in patients with previous respiratory pathology; however, its validity in this type of patient has not been proven.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID+ Group | – | Diagnostic Test: Roth´s TestPatients diagnosed with Covid19 positive in last 7 days |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects aged 18 to 90 years were recruited by non-probabilistic convenience sampling in Primary Health Care Centres of the Primary Health Care Management of SERMAS and the Intensive Care Unit of the University Hospital of Gran Canaria Doctor Negrín of the Canary Health Service
Key inclusion criteria (3 listed)
- having been diagnosed as COVID-19 positive and with symptoms compatible with Sars-Cov-2 infection in the last 7 days prior to assessment,
- having an understanding of Spanish,
- and having no history of respiratory pathology prior to the current infection.
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 |
|---|---|---|
| Roth´s TestSubjets must count from 1 to 30 in their languages, and health professional will count seconds that last in take breath during the count. | Diagnostic test | COVID+ Group |
Primary outcome
Oxygen Saturation
Time frame: 12 weeks
The pulseoximeter percentage value
1 secondary outcome
Roth´s test
Time frame: 12 weeks
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 6 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19, run by Universidad Autonoma de Madrid at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 6 Apr 2021. 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 Spain. 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?
Oxygen Saturation (time frame: 12 weeks). 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 6 Apr 2021.