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CompletedNCT04832828Updated Apr 6, 2021

Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive

An observational study in Covid19, sponsored by Universidad Autonoma de Madrid. Completed at 1 site in Spain. Open to participants aged 12 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-04-06.

Sponsored by Universidad Autonoma de Madrid · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
114
Ages
12 Years to 99 Years
Sex
All
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Study 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 of patient has not been proven.

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Conditions studied

  • Covid19

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 114 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

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Lead sponsor

Universidad Autonoma de Madrid is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Eligibility criteria

Inclusion Criteria:

  1. having been diagnosed as COVID-19 positive and with symptoms compatible with Sars-Cov-2 infection in the last 7 days prior to assessment,
  2. having an understanding of Spanish,
  3. and having no history of respiratory pathology prior to the current infection.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
114 participants (actual)
Patient registry
No

Groups and cohorts

  • COVID+ Group

    Patients diagnosed with Covid19 positive in last 7 days

    Diagnostic Test: Roth´s Test

Interventions

  • Diagnostic testRoth´s 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.

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What researchers measure

Primary outcomes

  1. Oxygen Saturation

    The pulseoximeter percentage value

    Time frame: 12 weeks

Secondary outcomes

  1. Roth´s test

    The level described in the test

    Time frame: 12 weeks

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Study locations

1 site
  • CS Entrevías
    Madrid, 28053, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04832828
Lead sponsor
Universidad Autonoma de Madrid
Responsible party
Raúl Ferrer-Peña (Principal investigator, Universidad Autonoma de Madrid) — Principal investigator
First posted
Apr 6, 2021
Start date
Jun 1, 2020
Primary completion
Nov 28, 2020
Completion
Nov 28, 2020
Last update
Apr 6, 2021
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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