Sensitivity and Specificity of the Roth Test in Patients... | NCT04832828

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

NCT04832828

Sponsor

Universidad Autonoma de Madrid

Status

Completed

Last Update Posted

Apr 6, 2021Actual

Enrollment

114Actual

Phase

Not provided

Conditions

Covid19

Interventions

Roth´s Test

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Nov 28, 2020Actual

Completion Date

Nov 28, 2020Actual

First Submitted Date

Mar 31, 2021

First Submission Date that Met QC Criteria

Apr 3, 2021

First Posted Date

Apr 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2021

Last Update Posted Date

Apr 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Raúl Ferrer-Peña, Principal investigator, Universidad Autonoma de MadridPrincipal Investigator

Lead Sponsor

Universidad Autonoma de MadridOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID+ Group		Patients diagnosed with Covid19 positive in last 7 days	Diagnostic Test: Roth´s Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Roth´s Test	Diagnostic 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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygen Saturation	The pulseoximeter percentage value	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Roth´s test	The level described in the test	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CS Entrevías		Madrid		28053	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided