HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With a SARS-CoV-2 Infection
HOME-CoV
1 other identifier
interventional
3,133
3 countries
29
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
29 active sites
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 5, 2020
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedStudy Start
First participant enrolled
April 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2020
CompletedSeptember 23, 2020
April 1, 2020
2 months
April 5, 2020
September 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Phase1: Before HOME-CoV rule implementation
NO INTERVENTIONObservational 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.
Phase 2: After HOME-CoV rule implementation
EXPERIMENTALObservational 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Clinique Universitaire Saint-Luc
Brussels, Belgium
CHU de Liège
Liège, Belgium
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
Hopital Paris Saint Joseph
Paris, France
Hopital Saint Antoine
Paris, France
Hôpital Bichat
Paris, France
Hôpital Lariboisière
Paris, France
CHU de Poitiers
Poitiers, 86000, France
CH Reims
Reims, France
Ch Remiremont
Remiremont, France
Chu Rennes
Rennes, France
CHU de Rouen
Rouen, France
CH de Saint-Brieuc
Saint-Brieuc, France
CHU de St Etienne
Saint-Etienne, 42000, France
Ch Troyes
Troyes, France
CH VICHY
Vichy, France
CH Princesse Grace
Monaco, Monaco
Related Publications (2)
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.
PMID: 34004154DERIVEDDouillet 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.
PMID: 32888112DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delphine DOUILLET
University Hospital, Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2020
First Posted
April 8, 2020
Study Start
April 9, 2020
Primary Completion
June 17, 2020
Study Completion
June 17, 2020
Last Updated
September 23, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share