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

Coronavirus Infection Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

• NCT number: NCT04657471
• Study type: Interventional
• Source: University Hospital, Angers
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Completion date: March 8, 2021