Clinical trial NCT04338841: HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With a SARS-CoV-2 Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infection
Keywords: covid-19
outpatient
expert consensus
decision-making
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-04-08
Enrollment: 3133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Quasi-experimental before and after multicentre prospective study
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the composite rate of adverse outcomes
timeFrame: day 7
measure: The rate of hospitalization
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Clinique Universitaire Saint-Luc
city: Liege
country: Belgium
facility: CHU de Liège
city: Argenteuil
country: France
facility: Ch Argenteuil
city: Cholet
country: France
facility: CH Cholet
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Colmar
country: France
facility: Ch Colmar
city: Contamine-sur-Arve
country: France
facility: CH Alpes Lemant
city: Dijon
country: France
facility: CHU Dijon
city: Le Mans
country: France
facility: CH Le Mans
city: Libourne
country: France
facility: CH Libourne
city: Limoges
country: France
facility: CH Limoges
city: Longjumeau
country: France
facility: Ch Longjumeau
city: Montpellier
country: France
facility: Chu Montpellier
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Niort
country: France
facility: CH Niort
city: Paris
country: France
facility: Hopital Paris Saint Joseph
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Lariboisière
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CH Reims
city: Remiremont
country: France
facility: Ch Remiremont
city: Rennes
country: France
facility: Chu Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint Etienne
country: France
facility: CHU de St Etienne
city: Saint-Brieuc
country: France
facility: CH de Saint-Brieuc
city: Troyes
country: France
facility: Ch Troyes
city: Vichy
country: France
facility: CH VICHY
city: Monaco
country: Monaco
facility: CH Princesse Grace
Study officials:
affiliation: University Hospital, Angers
name: Delphine DOUILLET
role: PRINCIPAL_INVESTIGATOR
References:
citation: Douillet D, Penaloza A, Mahieu R, Morin F, Chauvin A, Gennai S, Schotte T, Montassier E, Thiebaud PC, Ghuysen Francois A, Dall'acqua D, Benhammouda K, Bissokele P, Violeau M, Joly LM, Andrianjafy H, Soulie C, Savary D, Riou J, Roy PM; Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Study Group. Outpatient Management of Patients With COVID-19: Multicenter Prospective Validation of the Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Rule to Discharge Patients Safely. Chest. 2021 Oct;160(4):1222-1231. doi: 10.1016/j.chest.2021.05.008. Epub 2021 May 15.
citation: Douillet D, Mahieu R, Boiveau V, Vandamme YM, Armand A, Morin F, Savary D, Dubee V, Annweiler C, Roy PM; HOME-CoV expert group. Outpatient management or hospitalization of patients with proven or suspected SARS-CoV-2 infection: the HOME-CoV rule. Intern Emerg Med. 2020 Nov;15(8):1525-1531. doi: 10.1007/s11739-020-02483-0. Epub 2020 Sep 4.