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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338841
Recruitment Status : Completed
First Posted : April 8, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Coronavirus Infection Other: HOME-CoV rule implementation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3133 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Quasi-experimental before and after multicentre prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 9, 2020
Actual Primary Completion Date : June 17, 2020
Actual Study Completion Date : June 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Phase1: Before HOME-CoV rule implementation

Observational assessment of current practices: no recommendation is performed.

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.

Experimental: Phase 2: After HOME-CoV rule implementation

Observational assessment of practices after implementation of the rule: physicians are recommended to apply the HOME-CoV rule but still free to use other determinants in their decision.

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.

Other: HOME-CoV rule implementation

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 Outcome Measures :
  1. 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.

  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338841


Locations
Show Show 29 study locations
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Delphine DOUILLET University Hospital, Angers
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04338841    
Other Study ID Numbers: 2020-A00831-38
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
covid-19
outpatient
expert consensus
decision-making
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases