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

NCT ID: NCT04551781

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-07-30

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

steroid

20 mg prednisolone for 14 days

Group Type: EXPERIMENTAL

20 Mg Prednisone for 14 days

Intervention Type: DRUG

20 Mg Prednisone for 14 days

control

controll

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: DRUG

symptomatic ttt

Interventions

20 Mg Prednisone for 14 days

20 Mg Prednisone for 14 days

Intervention Type: DRUG

control

symptomatic ttt

Intervention Type: DRUG

Other Intervention Names

steroid; symptomatic ttt

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Rashad

assistant professor of chest diseases and tuberculosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

alaa DR Rashad, MD

Role: PRINCIPAL_INVESTIGATOR

south-Vally Universty

Locations

south-Vally University faculty of medicine

Qina, Qena Governorate, Egypt

Countries

Egypt

Other Identifiers

SVU-MED-CHT019420861

Identifier Type: -

Identifier Source: org_study_id