Back to resultsShort Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
20 Mg Prednisone for 14 days
control
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid-19, post covid-19 fibrosis, low dos steroids
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
Sites / Locations
- south-Vally University faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
steroid
control
Arm Description
20 mg prednisolone for 14 days
controll
Outcomes
Primary Outcome Measures
improved
resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, <5%, 5-25%and >25 % infiltrates
Secondary Outcome Measures
Full Information
NCT ID
NCT04551781
First Posted
September 13, 2020
Last Updated
September 14, 2020
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT04551781
Brief Title
Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis
Official Title
Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid-19, post covid-19 fibrosis, low dos steroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-blinded randomized controlled trial
Masking
Outcomes Assessor
Masking Description
single blinded
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
steroid
Arm Type
Experimental
Arm Description
20 mg prednisolone for 14 days
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
controll
Intervention Type
Drug
Intervention Name(s)
20 Mg Prednisone for 14 days
Other Intervention Name(s)
steroid
Intervention Description
20 Mg Prednisone for 14 days
Intervention Type
Drug
Intervention Name(s)
control
Other Intervention Name(s)
symptomatic ttt
Intervention Description
symptomatic ttt
Primary Outcome Measure Information:
Title
improved
Description
resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, <5%, 5-25%and >25 % infiltrates
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alaa DR Rashad, MD
Organizational Affiliation
south-Vally Universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
south-Vally University faculty of medicine
City
Qena
State/Province
Kena
ZIP/Postal Code
868532
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis
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