Home Care for Patients With COVID-19: Active Monitoring i... | NCT04361916

Studies
Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)

NCT04361916

Sponsor

Mario Negri Institute for Pharmacological Research

Status

Terminated

Last Update Posted

Sep 14, 2020Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

COVID-19

Interventions

home care monitoring

Countries

Italy

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

interrupted early due to the drastic reduction in the number of cases

Expanded Access Info

Start Date

Apr 21, 2020Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 23, 2020

First Posted Date

Apr 24, 2020Actual

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

Sep 10, 2020

Last Update Posted Date

Sep 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care.

Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.

Detailed Description

The study will include adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.

Trained health workers will conduct home care monitoring of pulmonary performance using oximetry, Quick Walk Test and Single Breath Count.

Monitoring will be done daily until disappearance of symptoms or hospitalization which will be requested by health workers or study coordination board on the basis of the monitoring results (blood oxygen level SpO2< 90% OR SpO2> 90% with desaturation index of at least 5% at Quick Walk Test)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
home care with active monitoring	Experimental	home care with active monitoring conducted by health workers with daily visit to patients.	Other: home care monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
home care monitoring	Other	home care active monitoring of patients with suspected of confirmed COVID-19	home care with active monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SpO2 at hospital entry	Peripheral blood saturation measured on arrival to the hospital	24 hours

Secondary Outcomes

Measure	Description	Time Frame
in-hospital mortality	death during hospitalization	30 days
need of intubation	need of intubation	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.

Exclusion criteria: physical, mental or temporary impairments that preclude the conduction of the test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guido Bertolini, MD	Mario Negri Institute for Pharmacological Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asl Alessandria		Casale Monferrato	Alessandria		Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

data will be available from the study sponsor upon legitimate request

Types

Study Protocol

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