Hospitalization or Outpatient ManagEment of Patients With SRAS-CoV-2 Infection - Revised HOME-CoV Score Study
- Conditions
- Coronavirus Infection
- Interventions
- Other: revised HOME-CoV score
- Registration Number
- NCT04657471
- Lead Sponsor
- University Hospital, Angers
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1300
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description revised HOMe-CoV revised HOME-CoV score Revised HOME-CoV
- Primary Outcome Measures
Name Time Method The safety of the revised HOME-CoV score strategy for home treatment 7 days 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%.
- Secondary Outcome Measures
Name Time Method The applicability of the revised HOME-CoV score strategy for home treatment 24 hours 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
Venous thrombo-embolism in COVID-19 patients (ancillary study) 7 days 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.
The reliability of the revised HOME-CoV score strategy for home treatment 7 days 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.
The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥5. 7 days 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 daysThe predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥6 7 days 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.Subgroup analysis in patients with confirmed COVID-19 (positive SARS-CoV2 RT-PCR) of the predictive performances of the revised HOME-CoV score 7 days 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.The predictive performances of the revised HOME-CoV score as compared to those of other prognostic scores for COVID-19 7 days 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)The efficacy of the revised HOME-CoV score strategy for home treatment 24 hours The rate of patients treated at home,i.e., discharged home within 24 hours following inclusion.
The predictive performances of the revised HOME-CoV score of evolution towards a fatal COVID-19 7 days 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.
Trial Locations
- Locations (1)
CHU Angers
🇫🇷Angers, France