P-CO-Li (Pulmonary Covid-19 Longterm Intervention Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Worsened pulmonary function test (PFT) (FVC or DLCO)
研究概览
简要总结
The aim of this study is to determine whether the use of steroids versus watchful waiting improves pulmonary function tests in patients with history of COVID 19 infection who have residual hypoxemia and lung infiltrates. This is a non-inferiority trial which tests whether the outcomes after watchful waiting are not worst than after the use of steroids, with a margin of acceptable inferiority. The study team will limit inclusion to patients who have PCR- confirmed COVID19 at least in 10-weeks prior to enrollment, persistent opacities on chest imaging, and hypoxemia either at rest or during ambulation.
详细描述
Rationale: The long-term pulmonary effects of COVID-19 infection have not been characterized. Many of the patients that have recovered from the initial infection still experience respiratory symptoms, require oxygen supplementation and/or have persistent opacities in chest imaging. The implications of these findings are not well described at this time, and it is unclear if these patients will eventually develop pulmonary fibrosis or fully recover. No standard therapy has been studied for this specific population and the use of steroids have only been tested in the acute setting. Outpatient providers are currently not sure whether to prescribe steroids or to carefully watch over time. This is a real-world question about which option is better and whether the risks of steroids outweigh the potential benefit when compared to watchful waiting. The investigator propose that watchful waiting is not inferior to the use of steroids in improving the pulmonary function tests of these patients at 12 weeks.
Methodology: The investigators will include patients with history of COVID-19 infection who have persistent opacities on chest imaging, and who are hypoxemic - either at rest or with ambulation, at least 10 weeks post-COVID19 PCR positivity. The study team will randomize patients in a 1:1 fashion to receive either watchful waiting vs. steroids. The study team will follow the patients over time with sequential pulmonary function tests and clinic visits at baseline, 12 weeks, 6 months and 12 months, 24 and 36 months. The first 12 weeks will include weekly brief phone calls to check on the patients and to ask them to rate their dyspnea on the modified Borg Dyspnea Scale. Thereafter, phone follow up will occur monthly.
Outcomes:
Outcomes will be measured at baseline, 12 weeks, 6-months, 12-months, 24-months, and 36-months. For the first 12 weeks weekly mBorg Dyspnea Scale will also be obtained.
The primary outcome will be worsening in pulmonary function tests (baseline to over 12 weeks), defined as absolute value of FVC worsened by >10% OR absolute value of DLCO worsened by >15%. As a real-world study, if patients are unable to receive PFTs before their physician decides to escalate therapy, a 2-point worsening (increase) in mBorg will be considered as patient having achieved the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Outpatients age>18 with PCR positive COVID19 at least 4-weeks prior;
- •persistent opacities (GGO and/or reticular changes) on any chest imaging at least 4-weeks after positive COVID PCR;
- •HYPOXEMIA as defined by any of the below:
- •Or patient already on supplemental oxygen
- •Or room air saturation 94% or less
排除标准
- •special populations (minors, pregnant women, decisional impairment which prevents them from making their own health decisions)
- •subjects with underlying ILD pre-COVID19 infection
结局指标
主要结局
Worsened pulmonary function test (PFT) (FVC or DLCO)
时间窗: Baseline to 12-weeks
Worsened PFT (FVC (forced vital capacity) or DLCO (diffusing capacity of the lungs for carbon monoxide)) at or prior to12 weeks. (FVC stayed the same if normal, or worsened by \>10% OR DLCO worsened by \>15%; or if start rescue treatment without pft we will assume it's a failed pft)\*\*
次要结局
- Hypoxemia(Baseline to 12 weeks; and 6, 12, 24 and 36-months)
- Lower Extremity Functional Scale(Baseline to 12 weeks; and 6, 12, 24 and 36-months)
- 6 Minute-Walk Test (6MWT)(Baseline to 12 weeks; and 6, 12, 24 and 36-months)
- mBorg Dyspnea Scale(Baseline to 12 weeks; and 6, 12, 24 and 36-months)
- EQ-5D-5L outcomes survey(Baseline to 12 weeks; and 6, 12, 24 and 36-months)
- Changes over time in CT chest sans(Baseline to 12 weeks; and 6, 12, 24 and 36-months)
- Other pulmonary function test (PFT) changes over time(Baseline to 12 weeks; and 6, 12, 24 and 36-months)
- PROMIS Short Forms Outcomes Survey(Baseline to 12 weeks; and 6, 12, 24 and 36-months)