Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- improved
研究概览
简要总结
A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates
详细描述
: the study included patients with COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest, patients with normal CT chest at discharge, patients on chemotherapy, patients <18years old, patients with known interstitial lung disease and patients with rheumatoid arthritis or systemic lupus erythematosus were excluded from the study.
Study patients were randomly assigned to either steroid group or control group and were followed up for 14 days, and CT chest was done at end of 14 days and was evaluated by a radiologist how was blinded for study arm, Ct chest was graded either very minimal infiltrates including reticular shadows, hallow sign, and ground glass s (GGO), infiltrates <25%, and infiltrates >25%.
The steroid group received 20 mg/day prednisolone for 14 days in addition to symptomatic treatment; the control group received symptomatic treatment without steroids Data collected included patient demographics, symptoms, and its duration at baseline, CBC, Ferritin and D-dime, CT chest at discharge, and after 14 days of inclusions in the study.
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
- Single (Outcomes Assessor)
盲法说明
single blinded
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
- •COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest
排除标准
- •patients with normal CT chest at discharge, patients on chemotherapy, patients <18years old, patients with known interstitial lung disease, and patients with rheumatoid arthritis or systemic lupus erythematosus
研究组 & 干预措施
steroid
20 mg prednisolone for 14 days
干预措施: 20 Mg Prednisone for 14 days (Drug)
control
controll
干预措施: control (Drug)
结局指标
主要结局
improved
时间窗: 14 days
resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, \<5%, 5-25%and \>25 % infiltrates
次要结局
未报告次要终点
研究者
Alaa Rashad
assistant professor of chest diseases and tuberculosis
South Valley University
