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

• ClinicalTrials.gov Identifier: NCT04361916
• Recruitment Status: Terminated
• First Posted: April 24, 2020
• Last Update Posted: September 14, 2020
• Sponsor: Mario Negri Institute for Pharmacological Research
• Information provided by (Responsible Party): Mario Negri Institute for Pharmacological Research

Tracking Information

• First Submitted Date: April 14, 2020
• First Posted Date: April 24, 2020
• Last Update Posted Date: September 14, 2020
• Actual Study Start Date: April 21, 2020
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: April 23, 2020)

SpO2 [ Time Frame: 24 hours ]

SpO2 at hospital entry

Current Secondary Outcome Measures (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 (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: Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: COVID-19

Intervention

Other: home care monitoring

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

Study Arms

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 10, 2020): 37
• Original Estimated Enrollment (submitted: April 23, 2020): 425
• Actual Study Completion Date: June 30, 2020
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04361916
• Other Study ID Numbers: 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

• 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: Mario Negri Institute for Pharmacological Research
• Collaborators: Not Provided

Investigators

• Principal Investigator: Guido Bertolini, MD; Mario Negri Institute for Pharmacological Research

• PRS Account: Mario Negri Institute for Pharmacological Research
• Verification Date: August 2020