HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With a SARS-CoV-2 Infection

COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death.

In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue.

HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method.

Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

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Key information

Conditions

Coronavirus Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Universitaire Saint-Luc, Brussels, Belgium

About this study

Definition of HOME-CoV rule:

The Delphi method is used to reach a consensus of a large panel of experts and to define an easy-to-use clinical rule aiming to help emergency physicians in hospitalisation or outpatient management decision making : the HOME-CoV rule.

The impact of the rule implementation is evaluated in a before and after study:

before period: observational assessment of current practices
implementation period : educational lectures, posters, and pocket cards showing and explaining HOME-CoV rule are communicated to participating Emergency Departments.
after period : observational assessment of practices

In each period, patients consulting Emergency Departments with suspected or probable COVID-19 are evaluated for potential inclusion. Clinical, biological and imaging data that may be involved in decision-making about hospitalization are collected as well as the physician final decision (hospitalization or outpatient management) and its main determinants.

A phone-call follow-up is performed and the clinical status according to the Ordinal Scale for Clinical Improvement of COVID-19 from the World Heath Organization is collected on day 7 and day 28 following inclusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 whose main diagnostic hypothesis in the emergency room is not a SARS-CoV-2 infection but another differential diagnosis,
Patient admitted to the emergency room for 18 hours or more,
Patient whose follow-up on D28 is impossible, whatever the reason,
Patient with a poor understanding of the French language,
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.

Treatment and study plan

HOME-CoV rule implementation

Other

HOME-CoV rule is an easy-to-use clinical rule aiming to help emergency physicians in hospitalisation or outpatient management decision making. The definition of the rule is performed using the Delphi method to reach a consensus of a large panel of experts.

Between before and after period, educational lectures, posters, and pocket cards showing and explaining HOME-CoV rule are communicated to participating Emergency Departments.

Primary outcomes

the composite rate of adverse outcomes

Time frame: day 7

Adverse outcomes include intubation with mechanical ventilation requirement and death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 7 days after inclusion.
The rate of hospitalization

Time frame: 24 hours

The rate of patients hospitalized after admission to the emergency room including patients discharged home more than 24 hours after admission.

It will be analyzed in a hierarchical approach, only if first primary objective is positive i.e. non-inferiority of HOME-CoV strategy versus current practice on the rate of adverse outcomes.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

Acronym: HOME-CoV

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 8, 2020
Registry last updated: Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed