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

NCT04657471 | Completed

• 1 other identifier: 2020-A03067-32
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Keywords

Outpatients; COVID-19; Risk assessment model; home treatment

Outcome Measures

Primary Outcomes (1)

• The safety of the revised HOME-CoV score strategy for home treatment

  The rate of patients with evolution to severe COVID-19 within 7 days after inclusion among patients with a revised HOME-CoV score \<2. Severe COVID-19 is defined as a WHO-OSCI≥5, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7), or all-cause death (8). The revised HOME-CoV score strategy will be considered as safe if the rate of patients who experienced a WHO-OSCI≥5, will be ≤0.5% with an upper limit of the 95% confidence interval ≤1%.

  7 days

Secondary Outcomes (9)

• The efficacy of the revised HOME-CoV score strategy for home treatment

  24 hours

• The applicability of the revised HOME-CoV score strategy for home treatment

  24 hours

• The reliability of the revised HOME-CoV score strategy for home treatment

  7 days

• The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥5.

  7 days

• The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥6

  7 days

Study Arms (1)

revised HOMe-CoV

EXPERIMENTAL

Revised HOME-CoV

Other: revised HOME-CoV score

Interventions

revised HOME-CoV score 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.

revised HOMe-CoV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, France

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medhi TAALBA

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• David DALL'ACQUA

  Jacques Lacarin Hospital Center

  PRINCIPAL INVESTIGATOR

• Anyhony CHAUVIN

  AP-HP Hopital Lariboisière

  PRINCIPAL INVESTIGATOR

• Emmanuel MONTASSIER

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Christian BRICE

  CH St Brieuc

  PRINCIPAL INVESTIGATOR

• Frédéric BALEN

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• Kasarra BEN HAMMOUDA

  CH Colmar

  PRINCIPAL INVESTIGATOR

• Marc NOIZET

  CHRU Mulhouse

  PRINCIPAL INVESTIGATOR

• Romain BLONDET

  Ch Mont de Marsan

  PRINCIPAL INVESTIGATOR

• Mustapha SEBBANE

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Pierre-Clément THIEBAUD

  AP-HP Hôpital St Antoine

  PRINCIPAL INVESTIGATOR

• Marc ANDRONIKOF

  AP-HP Hôpital Béclère

  PRINCIPAL INVESTIGATOR

• Esma OUMMAMAR

  CH Le Mans

  PRINCIPAL INVESTIGATOR

• Laure ABENSUR VUILLAUME

  CHRU Metz-Thionville

  PRINCIPAL INVESTIGATOR

• Henrinjatovo ANDRIANJAFY

  Groupe Hospitalier Nord Essonne - Longjumeau

  PRINCIPAL INVESTIGATOR

• Yann-Erick CLAESSENS

  CH Princesse Grace de Monaco

  PRINCIPAL INVESTIGATOR

• Pascal BISSOLOKELE

  CH Libourne

  PRINCIPAL INVESTIGATOR

• Francis COUTURAUD

  CHU Brest

  PRINCIPAL INVESTIGATOR

• Séverine GOSSELIN

  CHU Dijon

  PRINCIPAL INVESTIGATOR

• Mathieu VIOLEAU

  CH Niort

  PRINCIPAL INVESTIGATOR

• SCHMIDT Jeannot

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

• Henri Hani KARAM

  CHU Limoges

  PRINCIPAL INVESTIGATOR

• Meïssa KARE

  CH Agen

  PRINCIPAL INVESTIGATOR

• Coralie CAYEUX

  CH Remiremont

  PRINCIPAL INVESTIGATOR

• Florent FREMY

  AP-HP HEGP

  PRINCIPAL INVESTIGATOR

• Nicolas PESCHANSKI

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Caroline SOULIE

  CH Cholet

  PRINCIPAL INVESTIGATOR

• Ombeline SUSONG

  GHT La Rochelle

  PRINCIPAL INVESTIGATOR

• Stéphane GENNAI

  CHU REIMS

  PRINCIPAL INVESTIGATOR

• Julie PERNET

  AP-HP La Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

• Andrea PENALOZA

  Cliniques Universitaires St Luc (Bruxelles)

  PRINCIPAL INVESTIGATOR

• Alexandre GHUYSEN

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

• Sonja CURAC

  Hôpital Erasme (Bruxelles)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Multicentre prospective study

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 8, 2020
• Study Start: December 8, 2020
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: March 15, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)