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

Coronavirus Infection Clinical Trial

— HOME-CoV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338841
• Other study ID #: 2020-A00831-38
• Status: Completed
• Phase: N/A
• Start date: April 9, 2020
• Est. completion date: June 17, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3133
• Est. completion date: June 17, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Countries where clinical trial is conducted

Belgium,  France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the composite rate of adverse outcomes	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
Primary	The rate of hospitalization	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