HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With a SARS-CoV-2 Infection (HOME-CoV)

September 22, 2020 updated by: University Hospital, Angers

HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death.

In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue.

HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method.

Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Definition of HOME-CoV rule:

The Delphi method is used to reach a consensus of a large panel of experts and to define an easy-to-use clinical rule aiming to help emergency physicians in hospitalisation or outpatient management decision making : the HOME-CoV rule.

The impact of the rule implementation is evaluated in a before and after study:

  • before period: observational assessment of current practices
  • implementation period : educational lectures, posters, and pocket cards showing and explaining HOME-CoV rule are communicated to participating Emergency Departments.
  • after period : observational assessment of practices

In each period, patients consulting Emergency Departments with suspected or probable COVID-19 are evaluated for potential inclusion. Clinical, biological and imaging data that may be involved in decision-making about hospitalization are collected as well as the physician final decision (hospitalization or outpatient management) and its main determinants.

A phone-call follow-up is performed and the clinical status according to the Ordinal Scale for Clinical Improvement of COVID-19 from the World Heath Organization is collected on day 7 and day 28 following inclusion.

Study Type

Interventional

Enrollment (Actual)

3133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Clinique Universitaire Saint-Luc
      • Liege, Belgium
        • CHU de Liège
  • France
      • Argenteuil, France
        • CH Argenteuil
      • Cholet, France
        • Ch Cholet
      • Clermont Ferrand, France
        • CHU Clermont Ferrand
      • Colmar, France
        • CH Colmar
      • Contamine-sur-Arve, France
        • CH Alpes Lemant
      • Dijon, France
        • CHU Dijon
      • Le Mans, France
        • CH Le Mans
      • Libourne, France
        • CH Libourne
      • Limoges, France
        • CH Limoges
      • Longjumeau, France
        • CH Longjumeau
      • Montpellier, France
        • CHU Montpellier
      • Nantes, France
        • Centre Hospitalier Universitaire de Nantes
      • Niort, France
        • CH Niort
      • Paris, France
        • Hôpital Lariboisière
      • Paris, France
        • Hopital Bichat
      • Paris, France
        • Hopital Saint Antoine
      • Paris, France
        • Hopital Paris Saint Joseph
      • Poitiers, France, 86000
        • CHU de Poitiers
      • Reims, France
        • CH Reims
      • Remiremont, France
        • Ch Remiremont
      • Rennes, France
        • CHU Rennes
      • Rouen, France
        • CHU de ROUEN
      • Saint Etienne, France, 42000
        • CHU de St Etienne
      • Saint-Brieuc, France
        • CH de Saint-Brieuc
      • Troyes, France
        • CH Troyes
      • Vichy, France
        • CH Vichy
  • Monaco
      • Monaco, Monaco
        • CH Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient (≥ 18 years old)
  • Admitted for COVID-19 infection confirmed by a positive SARS-CoV2 RT-PCR or considered probable by the physician in charge of the patient.
  • Not requiring care in intensive care unit or resuscitation unit or
  • No subject of a limitation decision of active therapies,
  • Free informed express consent to participate in the study orally given or signed by the patient according to local legislation,
  • Insurance cover according to local legislation;

Exclusion Criteria:

  • Patient whose main diagnostic hypothesis in the emergency room is not a SARS-CoV-2 infection but another differential diagnosis,
  • Patient admitted to the emergency room for 18 hours or more,
  • Patient whose follow-up on D28 is impossible, whatever the reason,
  • Patient with a poor understanding of the French language,
  • Patient already included in the study,
  • Person deprived of their liberty by judicial or administrative decision,
  • Person under psychiatric care under duress,
  • Person subject to a legal protection measure,
  • Person unable to express consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Phase1: Before HOME-CoV rule implementation

Observational assessment of current practices: no recommendation is performed.

Patients consulting Emergency Departments with suspected or probable COVID-19 are evaluated for potential inclusion.

Clinical, biological and imaging data that may be involved in decision-making about hospitalization are collected as well as the physician final decision (hospitalization or outpatient management) and its main determinants.

A phone-call follow-up is performed and the clinical status according to the Ordinal Scale for Clinical Improvement of COVID-19 from the World Heath Organization is collected on day 7 and day 28 following inclusion.
EXPERIMENTAL: Phase 2: After HOME-CoV rule implementation

Observational assessment of practices after implementation of the rule: physicians are recommended to apply the HOME-CoV rule but still free to use other determinants in their decision.

Patients consulting Emergency Departments with suspected or probable COVID-19 are evaluated for potential inclusion. Clinical, biological and imaging data that may be involved in decision-making about hospitalization are collected as well as the physician final decision (hospitalization or outpatient management) and its main determinants.

A phone-call follow-up is performed and the clinical status according to the Ordinal Scale for Clinical Improvement of COVID-19 from the World Heath Organization is collected on day 7 and day 28 following inclusion.
Other: HOME-CoV rule implementation

HOME-CoV rule is an easy-to-use clinical rule aiming to help emergency physicians in hospitalisation or outpatient management decision making. The definition of the rule is performed using the Delphi method to reach a consensus of a large panel of experts.

Between before and after period, educational lectures, posters, and pocket cards showing and explaining HOME-CoV rule are communicated to participating Emergency Departments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the composite rate of adverse outcomes
Time Frame: day 7
Adverse outcomes include intubation with mechanical ventilation requirement and death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 7 days after inclusion.
day 7
The rate of hospitalization
Time Frame: 24 hours

The rate of patients hospitalized after admission to the emergency room including patients discharged home more than 24 hours after admission.

It will be analyzed in a hierarchical approach, only if first primary objective is positive i.e. non-inferiority of HOME-CoV strategy versus current practice on the rate of adverse outcomes.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Delphine DOUILLET, University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 9, 2020

Primary Completion (ACTUAL)

June 17, 2020

Study Completion (ACTUAL)

June 17, 2020

Study Registration Dates

First Submitted

April 5, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00831-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronavirus Infection

Clinical Trials on HOME-CoV rule implementation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe