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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361916
Recruitment Status : Terminated (interrupted early due to the drastic reduction in the number of cases)
First Posted : April 24, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Tracking Information
First Submitted Date  ICMJE April 14, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE April 21, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2020)
SpO2 at hospital entry [ Time Frame: 24 hours ]
Peripheral blood saturation measured on arrival to the hospital
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
SpO2 [ Time Frame: 24 hours ]
SpO2 at hospital entry
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2020)
  • in-hospital mortality [ Time Frame: 30 days ]
    death during hospitalization
  • need of intubation [ Time Frame: 30 days ]
    need of intubation
  • Percentage of hospitalized patients among those with recommendation of hospitalization [ Time Frame: 30 days ]
    To evaluate the feasibility of active monitoring, we will consider the percentage of patients who will be actually hospitalized within 24 hours after the recommendation of hospitalization
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
  • in-hospital mortality [ Time Frame: 30 days ]
    death during hospitalization
  • need of intubation [ Time Frame: 30 days ]
    need of intubation
  • feasibility of active monitoring [ Time Frame: 30 days ]
    percentage of patients with strongly recommendation to be hospitalised and with actual hospitalization by 24 hours after the recommendation .
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
Official Title  ICMJE Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
single arm, open label trial on active home monitoring strategy
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE COVID-19
Intervention  ICMJE Other: home care monitoring
home care active monitoring of patients with suspected of confirmed COVID-19
Study Arms  ICMJE Experimental: home care with active monitoring
home care with active monitoring conducted by health workers with daily visit to patients.
Intervention: Other: home care monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 10, 2020)
37
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2020)
425
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04361916
Other Study ID Numbers  ICMJE Mon-Covid
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: data will be available from the study sponsor upon legitimate request
Supporting Materials: Study Protocol
Responsible Party Mario Negri Institute for Pharmacological Research
Study Sponsor  ICMJE Mario Negri Institute for Pharmacological Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guido Bertolini, MD Mario Negri Institute for Pharmacological Research
PRS Account Mario Negri Institute for Pharmacological Research
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP