NCT04361916

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 14, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

April 14, 2020

Last Update Submit

September 10, 2020

Conditions

COVID-19

Keywords

COVID-19oximetryactive monitoringhome care

Outcome Measures

Primary Outcomes (1)

  • SpO2 at hospital entry

    Peripheral blood saturation measured on arrival to the hospital

    24 hours

Secondary Outcomes (3)

  • in-hospital mortality

    30 days

  • need of intubation

    30 days

  • Percentage of hospitalized patients among those with recommendation of hospitalization

    30 days

Study Arms (1)

home care with active monitoring

EXPERIMENTAL

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

Other: home care monitoring

Interventions

home care monitoringOTHER

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

home care with active monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asl Alessandria

Casale Monferrato, Alessandria, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Guido Bertolini, MD

    Mario Negri Institute for Pharmacological Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: single arm, open label trial on active home monitoring strategy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 24, 2020

Study Start

April 21, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

data will be available from the study sponsor upon legitimate request

Shared Documents
STUDY PROTOCOL

Locations

IT(1)