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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551781
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Rashad, 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

Condition or disease Intervention/treatment Phase
Covid19 Drug: 20 Mg Prednisone for 14 days Drug: control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-blinded randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: single blinded
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

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 Name: steroid

Placebo Comparator: control
controll
Drug: control
symptomatic ttt
Other Name: symptomatic ttt




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Egypt
south-Vally University faculty of medicine
Qena, Kena, Egypt, 868532
Sponsors and Collaborators
South Valley University
Investigators
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Principal Investigator: alaa DR Rashad, MD south-Vally Universty
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Responsible Party: Alaa Rashad, assistant professor of chest diseases and tuberculosis, South Valley University
ClinicalTrials.gov Identifier: NCT04551781    
Other Study ID Numbers: SVU-MED-CHT019420861
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alaa Rashad, South Valley University:
Covid-19
post covid-19 fibrosis
low dos steroids
Additional relevant MeSH terms:
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COVID-19
Pulmonary Fibrosis
Fibrosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents