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

NCT ID: NCT04657471

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2021-03-08

Brief 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.

Detailed Description

In all participating Emergency Departments, patients with highly suspected or confirmed COVID-19 are evaluated for potential inclusion. Clinical, biological, and imaging data that may be involved in decision-making about hospitalization, including all criteria of the revised HOME-CoV score, are collected. The revised HOME-CoV score is calculated. Patients with a score <2 qualify for home treatment. They qualify otherwise for hospitalization. For patients with a score > 4, hospitalization in a unit allowing monitoring of vital parameters is recommended. The qualification for home treatment or for hospitalization can be overruled by the physician-in-charge in case of major medical or social reasons. A justification explaining the cause of overruling is required.

A phone-call follow-up is performed on Day 7 and the patients' clinical status according to the Ordinal Scale for Clinical Improvement of COVID-19 from the World Health Organization (WHO-OSCI) is collected.

Conditions

Coronavirus Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

revised HOMe-CoV

Revised HOME-CoV

Group Type: EXPERIMENTAL

revised HOME-CoV score

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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 admitted to the emergency room for 18 hours or more,
• Patient whose follow-up on D7 is impossible, whatever the reason,
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medhi TAALBA

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

David DALL'ACQUA

Role: PRINCIPAL_INVESTIGATOR

Jacques Lacarin Hospital Center

Anyhony CHAUVIN

Role: PRINCIPAL_INVESTIGATOR

AP-HP Hopital Lariboisière

Emmanuel MONTASSIER

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Christian BRICE

Role: PRINCIPAL_INVESTIGATOR

CH St Brieuc

Frédéric BALEN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Kasarra BEN HAMMOUDA

Role: PRINCIPAL_INVESTIGATOR

CH Colmar

Marc NOIZET

Role: PRINCIPAL_INVESTIGATOR

CHRU Mulhouse

Romain BLONDET

Role: PRINCIPAL_INVESTIGATOR

Ch Mont de Marsan

Mustapha SEBBANE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Pierre-Clément THIEBAUD

Role: PRINCIPAL_INVESTIGATOR

AP-HP Hôpital St Antoine

Marc ANDRONIKOF

Role: PRINCIPAL_INVESTIGATOR

AP-HP Hôpital Béclère

Esma OUMMAMAR

Role: PRINCIPAL_INVESTIGATOR

CH Le Mans

Laure ABENSUR VUILLAUME

Role: PRINCIPAL_INVESTIGATOR

CHRU Metz-Thionville

Henrinjatovo ANDRIANJAFY

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Nord Essonne - Longjumeau

Yann-Erick CLAESSENS

Role: PRINCIPAL_INVESTIGATOR

CH Princesse Grace de Monaco

Pascal BISSOLOKELE

Role: PRINCIPAL_INVESTIGATOR

CH Libourne

Francis COUTURAUD

Role: PRINCIPAL_INVESTIGATOR

CHU Brest

Séverine GOSSELIN

Role: PRINCIPAL_INVESTIGATOR

CHU Dijon

Mathieu VIOLEAU

Role: PRINCIPAL_INVESTIGATOR

CH Niort

SCHMIDT Jeannot

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Henri Hani KARAM

Role: PRINCIPAL_INVESTIGATOR

CHU Limoges

Meïssa KARE

Role: PRINCIPAL_INVESTIGATOR

CH Agen

Coralie CAYEUX

Role: PRINCIPAL_INVESTIGATOR

CH Remiremont

Florent FREMY

Role: PRINCIPAL_INVESTIGATOR

AP-HP HEGP

Nicolas PESCHANSKI

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Caroline SOULIE

Role: PRINCIPAL_INVESTIGATOR

CH Cholet

Ombeline SUSONG

Role: PRINCIPAL_INVESTIGATOR

GHT La Rochelle

Stéphane GENNAI

Role: PRINCIPAL_INVESTIGATOR

CHU REIMS

Julie PERNET

Role: PRINCIPAL_INVESTIGATOR

AP-HP La Pitié-Salpêtrière

Andrea PENALOZA

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires St Luc (Bruxelles)

Alexandre GHUYSEN

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Liege

Sonja CURAC

Role: PRINCIPAL_INVESTIGATOR

Hôpital Erasme (Bruxelles)

Locations

CHU Angers

Angers, , France

Countries

France

Other Identifiers

2020-A03067-32

Identifier Type: -

Identifier Source: org_study_id