Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT04551781|
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: 20 Mg Prednisone for 14 days Drug: control||Not Applicable|
: 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||single-blinded randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||single blinded|
|Official Title:||Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis|
|Actual Study Start Date :||April 1, 2020|
|Actual Primary Completion Date :||July 30, 2020|
|Actual Study Completion Date :||July 30, 2020|
20 mg prednisolone for 14 days
Drug: 20 Mg Prednisone for 14 days
20 Mg Prednisone for 14 days
Other Name: steroid
Placebo Comparator: control
Other Name: symptomatic ttt
- improved [ Time Frame: 14 days ]resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, <5%, 5-25%and >25 % infiltrates
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551781
|south-Vally University faculty of medicine|
|Qena, Kena, Egypt, 868532|
|Principal Investigator:||alaa DR Rashad, MD||south-Vally Universty|