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

Not Applicable

Terminated

• Conditions: COVID-19
• Interventions: Other: home care monitoring

• Registration Number: NCT04361916
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

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 Timeline

• Study First Submitted: 2020-04-14
• Study Start: 2020-04-21
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
home care with active monitoring	home care monitoring	home care with active monitoring conducted by health workers with daily visit to patients.

Primary Outcome Measures

Name	Time	Method
SpO2 at hospital entry	24 hours	Peripheral blood saturation measured on arrival to the hospital

Secondary Outcome Measures

Name	Time	Method
in-hospital mortality	30 days	death during hospitalization
need of intubation	30 days	need of intubation
Percentage of hospitalized patients among those with recommendation of hospitalization	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

Trial Locations

Locations (1)

Asl Alessandria; 🇮🇹 Casale Monferrato, Alessandria, Italy