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

COVID-19 Clinical Trial

— Mon-Covid  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04361916
• Other study ID #: Mon-Covid
• Status: Terminated
• Phase: N/A
• Start date: April 21, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• home care monitoring
home care active monitoring of patients with suspected of confirmed COVID-19

Locations

Country	Name	City	State
Italy	Asl Alessandria	Casale Monferrato	Alessandria

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 at hospital entry	Peripheral blood saturation measured on arrival to the hospital	24 hours
Secondary	in-hospital mortality	death during hospitalization	30 days
Secondary	need of intubation	need of intubation	30 days
Secondary	Percentage of hospitalized patients among those with recommendation of hospitalization	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