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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657471
• Other study ID #: 2020-A03067-32
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: March 8, 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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