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

September 14, 2020 updated by: Alaa Rashad, South Valley University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Kena
      • Qena, Kena, Egypt, 868532
        • south-Vally University faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: steroid
20 mg prednisolone for 14 days
Drug: 20 Mg Prednisone for 14 days
20 Mg Prednisone for 14 days
Other Names:
  • steroid
Placebo Comparator: control
controll
Drug: control
symptomatic ttt
Other Names:
  • symptomatic ttt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Principal Investigator: alaa DR Rashad, MD, south-Vally Universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

July 30, 2020

Study Registration Dates

First Submitted

September 13, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU-MED-CHT019420861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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