Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- % of patients with radiological improvement
研究概览
简要总结
Aim: To investigate the efficacy of systemic corticosteroids in treatment for Post-COVID-19 Interstitial Lung Disease.
Method: Method: In this multi-centre, prospective, randomised controlled open label clinical trial, patients are divided into two arms: standard treatment arm and standard plus systemic corticosteroid arm. After twelve weeks; clinical, functional, and radiological improvement will being assessed as primary outcomes.
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
- 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
- •Post-COVID-19 Interstitial Lung Disease (ILD) patients who had completed the treatment of acute phase and have recovered, but despite after 90 days from recovery diagnosed as post-COVID ILD based upon the persistent respiratory symptoms with functional impairment and radiological sequela.
- •At least 90 days required after discharge for hospitalized patients or termination of isolation for outpatients
- •Confirmation of the diagnosis of COVID-19 via real time polymerase chain reaction assay (rt-PCR) or antigen or antibody test in the acute phase of COVID-
- •Presence of sequelae interstitial changes in follow-up (pre-enrollment) thorax high-resolution computed tomography (HRCT)/CT.
- •Presence of persistent respiratory symptoms in the post-COVID-19 period or hypoxemia at rest and/or desaturation with exercise.
排除标准
- •Patients who had a normal lung imaging examination (radiography, tomography, etc.) at discharge or enrollment phase
- •Pre-existing diffuse parenchymal lung disease before pandemic
- •Cystic bronchiectasis
- •Presence of contraindications for systemic corticosteroids (uncontrolled Diabetes, uncontrolled Hypertension, unstable angina pectoris, history of acute coronary syndrome at last month, presence of active infection, active peptic ulcer, presence of uncontrolled psychiatric disease, etc.)
- •Decompensated heart failure
- •Contraindications for pulmonary function tests and those who cannot cooperate with the test
- •Younger than 18 years old
- •Pregnant women
- •Breastfeeding women
- •Those who do not give written consent
研究组 & 干预措施
Steroid
Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks; followed by a gradual reduction of 25% every 2 weeks.
Total Duration:12-16 weeks
干预措施: Methylprednisolone Tablet (Drug)
control
standard symptom-relief therapy (since there is no current standard therapy for post-COVID Interstitial Lung Disease, patients in this arm will be commenced symptom-relief therapies including bronchodilators, inhaled corticosteroids, non-steroid anti-inflammatories, cough relievers, and long-term oxygen if the patient has respiratory failure)
干预措施: Methylprednisolone Tablet (Drug)
结局指标
主要结局
% of patients with radiological improvement
时间窗: 12 weeks
At least 50% regression in extension of interstitial lesions on thorax CT. (Thorax CT images will be assessed by a radiologist and a pulmonologist who is expertised in thoracic CT.)
% of patients with functional improvement
时间窗: 12 weeks
A combination of following features: Sp02 is greater than 95% at rest; No desaturation during 6MWT; FVC is greater than 80%; DLCO is greater than 80%
% of patients with clinical improvement
时间窗: 12 weeks
Clinical improvement is identified as grade 0 modified Medical Research Council (mMRC) dyspnea score with no respiratory complaints.
次要结局
- Mortality rate(12 weeks)
- Advers events(12 weeks)
- Improvement of Forced Vital Capacity (FVC)(12 weeks)
- Improvement of arterial oxygen saturation (SaO2)(12 weeks)
- Respiratory-cause emergency visit and hospitalisation(12 weeks)
- Improvement of Exercise Capacity(12 weeks)
- Improvement of mMRC dyspnea score(12 weeks)
- Improvement of diffusion capacity of lung for carbon monoxide (DLCO)(12 weeks)
研究者
Metin Akgun
MD, Professor
Turkish Thoracic Society