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Clinical Trials/NCT04551781
NCT04551781
Completed
Not Applicable

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

South Valley University1 site in 1 country450 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
20 Mg Prednisone for 14 days
Conditions
Covid19
Sponsor
South Valley University
Enrollment
450
Locations
1
Primary Endpoint
improved
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
July 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alaa Rashad

assistant professor of chest diseases and tuberculosis

South Valley University

Eligibility Criteria

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

Arms & Interventions

steroid

20 mg prednisolone for 14 days

Intervention: 20 Mg Prednisone for 14 days

control

controll

Intervention: control

Outcomes

Primary Outcomes

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

Study Sites (1)

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