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

Hospitalization or Outpatient ManagEment of Patients With Suspected or Confirmed SRAS-CoV-2 Infection: the Revised HOME-CoV Score Study.

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection
• Intervention / Treatment: Other: revised HOME-CoV score

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.

• Study Type: Interventional
• Enrollment (Actual): 1300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: revised HOMe-CoV; Revised HOME-CoV

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of the revised HOME-CoV score strategy for home treatment	The rate of patients treated at home,i.e., discharged home within 24 hours following inclusion.	24 hours
The applicability of the revised HOME-CoV score strategy for home treatment	the rate of patients treated at home, i.e., discharged home within 24 hours following inclusion, among patients with a revised HOME-CoV score <2	24 hours
The reliability of the revised HOME-CoV score strategy for home treatment	The rate of patients with a revised HOME-CoV score < 2 and treated at home who were not subsequently hospitalized within the 7 days following inclusion.	7 days
The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥5.	The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, 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 following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs. 7 days	7 days
The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥6	The rate of patients with a WHO-OSCI≥6 within the 7 days following inclusion, i.e., intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.	7 days
The predictive performances of the revised HOME-CoV score of evolution towards a fatal COVID-19	The rate of patients who dead within the 7 days following inclusion The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.	7 days
Subgroup analysis in patients with confirmed COVID-19 (positive SARS-CoV2 RT-PCR) of the predictive performances of the revised HOME-CoV score	The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, 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 following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.	7 days
The predictive performances of the revised HOME-CoV score as compared to those of other prognostic scores for COVID-19	The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, 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 following parameters will be calculated: the area under the receiving operating curve (AUROC)	7 days
Venous thrombo-embolism in COVID-19 patients (ancillary study)	The rate of symptomatic and objectively confirmed deep venous thromboembolism or pulmonary embolism, and of unexplained sudden death occurring within the 7 days following ED admission.	7 days

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Medhi TAALBA, CHU Rouen; Principal Investigator: David DALL'ACQUA, Jacques Lacarin Hospital Center; Principal Investigator: Anyhony CHAUVIN, Ap-Hp Hopital Lariboisiere; Principal Investigator: Emmanuel MONTASSIER, CHU Nantes; Principal Investigator: Christian BRICE, CH St Brieuc; Principal Investigator: Frédéric BALEN, CHU 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-Salpétrière; 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)

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): March 8, 2021
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Outpatients; Risk assessment model; home treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Disease Attributes; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: 2020-A03067-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No