Clinical trial NCT04657471: Hospitalization or Outpatient ManagEment of Patients With SRAS-CoV-2 Infection - Revised HOME-CoV Score Study
Official title: Hospitalization or Outpatient ManagEment of Patients With Suspected or Confirmed SRAS-CoV-2 Infection: the Revised HOME-CoV Score Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infection
Keywords: Outpatients
COVID-19
Risk assessment model
home treatment
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-12-08
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicentre prospective study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The safety of the revised HOME-CoV score strategy for home treatment
timeFrame: 7 days
Secondary outcomes:
measure: The efficacy of the revised HOME-CoV score strategy for home treatment
timeFrame: 24 hours
measure: The applicability of the revised HOME-CoV score strategy for home treatment
timeFrame: 24 hours
measure: The reliability of the revised HOME-CoV score strategy for home treatment
timeFrame: 7 days
measure: The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥5.
timeFrame: 7 days
measure: The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥6
timeFrame: 7 days
measure: The predictive performances of the revised HOME-CoV score of evolution towards a fatal COVID-19
timeFrame: 7 days
measure: Subgroup analysis in patients with confirmed COVID-19 (positive SARS-CoV2 RT-PCR) of the predictive performances of the revised HOME-CoV score
timeFrame: 7 days
measure: The predictive performances of the revised HOME-CoV score as compared to those of other prognostic scores for COVID-19
timeFrame: 7 days
measure: Venous thrombo-embolism in COVID-19 patients (ancillary study)
timeFrame: 7 days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: CHU Rouen
name: Medhi TAALBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Jacques Lacarin Hospital Center
name: David DALL'ACQUA
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP Hopital Lariboisière
name: Anyhony CHAUVIN
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Emmanuel MONTASSIER
role: PRINCIPAL_INVESTIGATOR
affiliation: CH St Brieuc
name: Christian BRICE
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Toulouse
name: Frédéric BALEN
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Colmar
name: Kasarra BEN HAMMOUDA
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Mulhouse
name: Marc NOIZET
role: PRINCIPAL_INVESTIGATOR
affiliation: Ch Mont de Marsan
name: Romain BLONDET
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Montpellier
name: Mustapha SEBBANE
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP Hôpital St Antoine
name: Pierre-Clément THIEBAUD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP Hôpital Béclère
name: Marc ANDRONIKOF
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Le Mans
name: Esma OUMMAMAR
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Metz-Thionville
name: Laure ABENSUR VUILLAUME
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe Hospitalier Nord Essonne - Longjumeau
name: Henrinjatovo ANDRIANJAFY
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Princesse Grace de Monaco
name: Yann-Erick CLAESSENS
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Libourne
name: Pascal BISSOLOKELE
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brest
name: Francis COUTURAUD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Dijon
name: Séverine GOSSELIN
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Niort
name: Mathieu VIOLEAU
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: SCHMIDT Jeannot
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Limoges
name: Henri Hani KARAM
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Agen
name: Meïssa KARE
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Remiremont
name: Coralie CAYEUX
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP HEGP
name: Florent FREMY
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Nicolas PESCHANSKI
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Cholet
name: Caroline SOULIE
role: PRINCIPAL_INVESTIGATOR
affiliation: GHT La Rochelle
name: Ombeline SUSONG
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU REIMS
name: Stéphane GENNAI
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP La Pitié-Salpêtrière
name: Julie PERNET
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques Universitaires St Luc (Bruxelles)
name: Andrea PENALOZA
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Liege
name: Alexandre GHUYSEN
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Erasme (Bruxelles)
name: Sonja CURAC
role: PRINCIPAL_INVESTIGATOR
References: