Hospitalization or Outpatient ManagEment of Patients With SRAS-CoV-2 Infection - Revised HOME-CoV Score Study

Summary

In the context of COVID-19 pandemic, identifying low-risk patients who can be safely treated at home and high-risk patients requiring hospitalization or even intensive care is crucial for Emergency Departments. Thanks to a consensus of experts using the Delphi method, we previously defined the HOME-CoV rule. The HOME-CoV rule consists of 8 items precluding home treatment for patients consulting in the Emergency Department (ED) with confirmed or highly suspected mild to moderate COVID-19. It has been validated in a prospective study, patients with a negative rule having a very-low rate of invasive ventilation or death within the 7 days following ED presentation (HOME-CoV study, NCT: 02811237).

Using logistic regression, we revised the HOME-CoV rule in order to define a score allowing. The revised HOME-CoV score comprises 7 criteria and, retrospectively assessed in the database of the HOME-CoV study, it exhibits promising performances. A revised HOME-CoV score \< 2 had a sensitivity of 0.93 (0.84 to 0.98), a specificity of 0.60 (0.58 to 0.61) and negative predictive value of 1.00 (0.99 to 1.00); and a score \> 4 had a sensitivity of 0.41 (0.28 to 0.54), a specificity of 0.93 (0.92 to 0.94) and a positive predictive value of 0.11 (0.07 to 0.16).

The present study aims to prospectively validate the revised HOME-CoV score, firstly, in identifying a subgroup of COVID-19 patients with a low risk of evolution to severe COVID-19 and who could be safely treated at home.

For this purpose, we will perform an interventional multicentric prospective pragmatic cohort study with implementation of the revised HOME-CoV score to triage COVID-19 patients.

Conditions

• Coronavirus Infection

Interventions

OTHER

revised HOME-CoV score

Educational lectures, posters, and pocket cards showing and explaining the revised HOME-CoV score are communicated to participating Emergency Departments. For included patients, the physician-in-charge calculates the revised HOME-CoV. Patients with a score \<2 qualified for home treatment. They qualified otherwise for hospitalization. For patients with a score \> 4, hospitalization in a unit allowing monitoring of vital parameters is recommended. However, the physician-in-charge can overrule the qualification for home treatment or for hospitalization in case of major medical or social reasons. A justification explaining the cause of overruling is required.

Sponsors & Collaborators

• University Hospital, Angers

  lead OTHER_GOV

Principal Investigators

• Medhi TAALBA · CHU Rouen

• David DALL'ACQUA · Jacques Lacarin Hospital Center

• Anyhony CHAUVIN · AP-HP Hopital Lariboisière

• Emmanuel MONTASSIER · Nantes University Hospital

• Christian BRICE · CH St Brieuc

• Frédéric BALEN · University Hospital, Toulouse

• Kasarra BEN HAMMOUDA · CH Colmar

• Marc NOIZET · CHRU Mulhouse

• Romain BLONDET · Ch Mont de Marsan

• Mustapha SEBBANE · University Hospital, Montpellier

• Pierre-Clément THIEBAUD · AP-HP Hôpital St Antoine

• Marc ANDRONIKOF · AP-HP Hôpital Béclère

• Esma OUMMAMAR · CH Le Mans

• Laure ABENSUR VUILLAUME · CHRU Metz-Thionville

• Henrinjatovo ANDRIANJAFY · Groupe Hospitalier Nord Essonne - Longjumeau

• Yann-Erick CLAESSENS · CH Princesse Grace de Monaco

• Pascal BISSOLOKELE · CH Libourne

• Francis COUTURAUD · CHU Brest

• Séverine GOSSELIN · CHU Dijon

• Mathieu VIOLEAU · CH Niort

• SCHMIDT Jeannot · University Hospital, Clermont-Ferrand

• Henri Hani KARAM · CHU Limoges

• Meïssa KARE · CH Agen

• Coralie CAYEUX · CH Remiremont

• Florent FREMY · AP-HP HEGP

• Nicolas PESCHANSKI · CHU Rennes

• Caroline SOULIE · CH Cholet

• Ombeline SUSONG · GHT La Rochelle

• Stéphane GENNAI · CHU REIMS

• Julie PERNET · AP-HP La Pitié-Salpêtrière

• Andrea PENALOZA · Cliniques Universitaires St Luc (Bruxelles)

• Alexandre GHUYSEN · Centre Hospitalier Universitaire de Liege

• Sonja CURAC · Hôpital Erasme (Bruxelles)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-08

Primary Completion

2021-03-08

Completion

2021-03-08

Countries

• France

Study Locations