Hospitalization or Outpatient ManagEment of Patients With Suspected or Confirmed SRAS-CoV-2 Infection: the Revised HOME-CoV Score Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- The safety of the revised HOME-CoV score strategy for home treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
The safety of the revised HOME-CoV score strategy for home treatment
时间窗: 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%.
次要结局
- The applicability of the revised HOME-CoV score strategy for home treatment(24 hours)
- Venous thrombo-embolism in COVID-19 patients (ancillary study)(7 days)
- The reliability of the revised HOME-CoV score strategy for home treatment(7 days)
- The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥5.(7 days)
- The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥6(7 days)
- 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 predictive performances of the revised HOME-CoV score as compared to those of other prognostic scores for COVID-19(7 days)
- The efficacy of the revised HOME-CoV score strategy for home treatment(24 hours)
- The predictive performances of the revised HOME-CoV score of evolution towards a fatal COVID-19(7 days)