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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| revised HOMe-CoV | Experimental | Revised HOME-CoV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | CHI MONT DE MARSAN ET PAYS DES SOURCES | Principal Investigator |
| Mustapha SEBBANE | University Hospital, Montpellier |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Multicentre prospective study
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|
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 |
| 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 | Rennes University Hospital | Principal Investigator |
| Caroline SOULIE | CH Cholet | Principal Investigator |
| Ombeline SUSONG | GHT La Rochelle | Principal Investigator |
| Stéphane GENNAI | CHU de 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 |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |