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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Other: home care monitoring Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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
Official Title: Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
Actual Study Start Date : April 21, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: home care with active monitoring
home care with active monitoring conducted by health workers with daily visit to patients.
 Other: home care monitoring
home care active monitoring of patients with suspected of confirmed COVID-19


Outcome Measures
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Primary Outcome Measures :
  1. SpO2 at hospital entry [ Time Frame: 24 hours ]
    Peripheral blood saturation measured on arrival to the hospital


Secondary Outcome Measures :
  1. in-hospital mortality [ Time Frame: 30 days ]
    death during hospitalization

  2. need of intubation [ Time Frame: 30 days ]
    need of intubation

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361916


Locations
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Italy
Asl Alessandria
Casale Monferrato, Alessandria, Italy
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
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Principal Investigator: Guido Bertolini, MD Mario Negri Institute for Pharmacological Research
More Information
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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT04361916    
Other Study ID Numbers: Mon-Covid
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data will be available from the study sponsor upon legitimate request
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario Negri Institute for Pharmacological Research:
COVID-19
oximetry
active monitoring
home care