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Clinical Trials/NCT04361916
NCT04361916
Terminated
Not Applicable

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

Mario Negri Institute for Pharmacological Research1 site in 1 country37 target enrollmentApril 21, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Mario Negri Institute for Pharmacological Research
Enrollment
37
Locations
1
Primary Endpoint
SpO2 at hospital entry
Status
Terminated
Last Updated
5 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
April 21, 2020
End Date
June 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Mario Negri Institute for Pharmacological Research
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

SpO2 at hospital entry

Time Frame: 24 hours

Peripheral blood saturation measured on arrival to the hospital

Secondary Outcomes

  • in-hospital mortality(30 days)
  • need of intubation(30 days)
  • Percentage of hospitalized patients among those with recommendation of hospitalization(30 days)

Study Sites (1)

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