Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Drug: 20 Mg Prednisone for 14 days; Drug: control

• Registration Number: NCT04551781
• Lead Sponsor: South Valley University

Brief Summary

A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates

Detailed Description

: 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 Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-13
• Study First Submitted QC: 2020-09-14
• Last Update Submitted: 2020-09-14
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
steroid	20 Mg Prednisone for 14 days	20 mg prednisolone for 14 days
control	control	controll

Primary Outcome Measures

Name	Time	Method
improved	14 days	resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, \<5%, 5-25%and \>25 % infiltrates

Trial Locations

Locations (1)

south-Vally University faculty of medicine; 🇪🇬 Qena, Kena, Egypt