NCT04832828

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

March 31, 2021

Last Update Submit

April 3, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Oxygen Saturation

    The pulseoximeter percentage value

    12 weeks

Secondary Outcomes (1)

  • Roth´s test

    12 weeks

Study Arms (1)

COVID+ Group

Patients diagnosed with Covid19 positive in last 7 days

Diagnostic Test: Roth´s Test

Interventions

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.

COVID+ Group

Eligibility Criteria

Age12 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CS Entrevías

Madrid, 28053, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 6, 2021

Study Start

June 1, 2020

Primary Completion

November 28, 2020

Study Completion

November 28, 2020

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)