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临床试验/NCT04551781
NCT04551781已完成不适用

Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis

South Valley University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2020年4月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

20 mg prednisolone for 14 days

干预措施: 20 Mg Prednisone for 14 days (Drug)

control

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Rashad

assistant professor of chest diseases and tuberculosis

South Valley University

研究点 (1)

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