Post COVID-19 Hypoxemic Respiratory Failure Residual Pathophysiologic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Change in fibrotic and non-fibrotic interstitial opacities on chest HRCT at 48 weeks after hospitalization for COVID-19 or outpatient COVID-19 infections which require treatment with supplemental oxygen
研究概览
简要总结
This is a 48-week, observational study looking to see if the inflammatory process of hypoxemic respiratory failure associated with COVID-19 leads to progressive pulmonary fibrosis. Inpatient, as well as outpatient adults with recent COVID-19 hospitalization will be recruited. Data from hospitalization will be collected and subjects will return to the center for follow-up visits. Subjects will undergo the following procedures: High Resolution Computed Tomography (HRCT) of the chest, Pulmonary Function Tests (PFT), Muscle Strength Measurement, and blood draw for biomolecular data such as biomarkers found in ribonucleic acid (RNA), deoxyribonucleic acid (DNA), serum, and plasma. Quality of Life (QoL) measurements will also be collected through the study.
详细描述
This is a multi-center, observational, and prospective study collecting data on subjects who were hospitalized with hypoxemic respiratory failure associated with COVID-19 or patients who have evidence of an outpatient COVID-19 infection that have been treated with supplemental oxygen.
A total of approximately 300 subjects will be enrolled in the study. Subjects will be enrolled into one of 3 cohorts.
Cohort 1: Inpatient Enrollment: Subjects enrolled while hospitalized for COVID-19, prior to discharge.
Cohort 2: Outpatient Enrollment: Subjects enrolled up to 4 weeks after discharge from hospitalization for COVID-19 or 4 weeks post their outpatient COVID -19 infection.
Cohort 3: Outpatient Enrollment: Subjects enrolled between 6 and 24 weeks after discharge from hospitalization for COVID-19 or 6 and 24 weeks post their outpatient COVID -19 infection. Cohort 3 will be sub-divided into 3a and 3b depending on the timepoint of enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written Informed Consent consistent with International Conference on Harmonization Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study
- •Male or female ≥ 18 years of age at the time of consent
- •SARS-CoV-2 positive confirmed by a positive serology or PCR or antigen test
- •COVID-19 induced hypoxemia or reduced oxygen saturation requiring treatment with supplemental oxygen.
- •COVID-19 hospital discharge date or outpatient COVID-19 infection within 24 weeks of enrollment
排除标准
- •Diagnosed with Fibrotic Interstitial Lung Disease (ILD) prior to COVID-19 infection.
- •Prior treatment with an antifibrotic agent, including nintedanib or pirfenidone
- •Pregnant women or women planning on becoming pregnant in the next 12 months
- •Patients planned for discharge from the hospital to hospice
- •Patients with significant cognitive impairment
结局指标
主要结局
Change in fibrotic and non-fibrotic interstitial opacities on chest HRCT at 48 weeks after hospitalization for COVID-19 or outpatient COVID-19 infections which require treatment with supplemental oxygen
时间窗: 48 Weeks
Categorized after exploratory analysis as improved, stable or worsened fibrotic changes seen on chest HRCT.
次要结局
- Changes from baseline and evidence of disease progression seen on high resolution computed tomography(72 Weeks)
- Changes from baseline and evidence of disease progression seen on pulmonary function testing(72 weeks)
- Changes from baseline and evidence of disease progression via 6 Minute Walk Test(72 weeks)
- Changes from baseline and evidence of disease progression by Hand Grip Strength(72 weeks)
- Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. St. George's Respiratory Questionnaire (SGRQ)(72 weeks)
- Changes from baseline and evidence of disease progression on pulmonary function testing(72 weeks)
- Changes from baseline and evidence of disease progression see on pulmonary function testing(72 weeks)
- Change in pre- and post- six minute walk test Borg Scale Dyspnea score from baseline and at 12, 24, and 48 weeks.(72 weeks)
- Change in pre- and post- six minute walk test Borg Scale Fatigue score from baseline and at 12, 24, and 48 weeks.(72 weeks)
- Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. EuroQol-5D (EQ-5D)(72 weeks)
- Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes- PROMIS-29 + 2 Profile(72 weeks)
- Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. Generalized Anxiety 7-Item (GAD-7)(72 weeks)
- Examine the effects of COVID-19 on the presence of molecular biomarkers associated with Interstitial Lung Disease(72 weeks)
- Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes. Patient Health Questionnaire 9 (PHQ-9)(72 weeks)
- Changes from baseline and evidence of disease progression per the Quality of Life reported outcomes- Impact of Events Scale Revised (IES-R)(72 weeks)