- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04361916
Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino) (Mon-Covid)
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.
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alessandria
-
Casale Monferrato, Alessandria, Italy
- Asl Alessandria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: home care with active monitoring
home care with active monitoring conducted by health workers with daily visit to patients.
|
home care active monitoring of patients with suspected of confirmed COVID-19
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SpO2 at hospital entry
Time Frame: 24 hours
|
Peripheral blood saturation measured on arrival to the hospital
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
in-hospital mortality
Time Frame: 30 days
|
death during hospitalization
|
30 days
|
need of intubation
Time Frame: 30 days
|
need of intubation
|
30 days
|
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
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Guido Bertolini, MD, Mario Negri Institute for Pharmacological Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mon-Covid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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