Corticosteroid Therapy in Pulmonary Sequelae of Covid-19

NCT07380152 | Completed Phase 1

• 1 other identifier: 47222421.7.0000.5440
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The new coronavirus (SARS-CoV-2) is a virus with an intense capacity for dissemination and high mortality rate. The main cause of death is viral pneumonia, characterized as organizing pneumonia that responds to treatment with corticosteroids. After 1 month of the acute phase, 25% of patients have complete recovery from lung lesions. However, lung lesions can evolve as persistent interstitial lung disease; it is possible that this persistent disease is also responsive to corticosteroid therapy. There are no controlled and randomized studies on any treatment and its effect on the natural history of this subacute or late manifestation of COVID-19. Objective: To understand the effect of oral corticosteroid therapy in the treatment of persistent pulmonary manifestations (clinical and radiological) in patients who had moderate, severe, and critical forms of COVID-19. To understand the role of some risk factors in the development of this form of lung disease. To add information on the natural history of interstitial lung disease secondary to SARS-CoV-2 pulmonary infection. Methodology: Randomized, double-blind, placebo-controlled study of patients who had COVID-19 viral pneumonia. Patients included after 12 weeks of COVID-19 diagnosis with RT-PCR or imaging tests that confirm the infection for inclusion in the protocol 100 patients with changes in high-resolution chest tomography and diffusion spirometry, will be divided into two groups, placebo and treatment; the treatment group will receive prednisolone at a dose of 0.5 mg/kg/day for 1 month and weaning in 30 days. Clinical, laboratory, functional, and imaging evaluations will be performed at the beginning, after 3 and 6 months of treatment and monthly telephone calls. The evaluation will include a medical evaluation aimed at the cardiopulmonary assessment, arterial blood gas analysis at rest and after 6MWT; functional assessment with spirometry with measurements of FEV1, FVC, TLC, and DLCO; functional assessment during exercise with 6MWT; functionality questionnaires with SF-36, MMRC, and PCFS; and collection of laboratory tests including inflammatory markers - D-dimers, blood count, C-reactive protein and ESR, autoimmunity markers (ANA and RF), and collection of medical and laboratory history data during the acute infection to verify correlation with residual lung disease. Imaging evaluation will be performed with high-resolution chest tomography.

Conditions

COVID-19 Pulmonary Complications

Keywords

Corticosteroid therapy in post-COVID-19 pulmonary sequelae; post-COVID-19 pulmonary disease; Interstitial lung disease; treatment DPI post-COVID-19

Outcome Measures

Primary Outcomes (1)

• The rate of radiological, functional and quality of life improvement in prednisolone treatment for persistent interstitial lung disease following SARS-CoV-2.

  Rate of improvement, after treatment with prednisolone, of radiological, functional, and quality of life parameters in patients with persistent interstitial lung disease resulting from SARS-CoV-2 infection, in moderate, severe, and critical forms of COVID-19. Assessments were performed at 4, 7, and 10 months after diagnosis, .

  10 months

Secondary Outcomes (2)

• The incidence of risk factors that may influence the severe outcome of COVID-19 lung disease.

  In the first evaluation, 4 months after diagnosis.

• Monitoring of post-COVID lung disease.

  During recruitment and monitoring.

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Treatment: corticosteroid therapy with prednisolone at a dose of half a milligram per kilogram per day, lasting 1 month, which will be gradually withdrawn with a 50% reduction in the dose every 7 days, up to a minimum dose of 5 mg for 7 days before stopping completely. The placebo group will receive tablets identical to prednisolone 20 mg for 1 month, and then the reduction will be done with placebo tablets identical to the 20 mg and 5 mg tablets. The identification of the bottles and the preparation of the placebo tablets will be carried out by a compounding pharmacy that will identify the labels by codes, and a researcher on the team will learn the content related to each code (placebo or prednisolone). This researcher will not have access to the study care or procedures.

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

Patients who received placebo took a similar number of tablets for similar time span.

Drug: Prednisolone

Interventions

Prednisolone DRUG

Prednisone in anti-inflammatory dose

Also known as: Corticosteroid therapy

Placebo; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age;
• Diagnosis of COVID-19 by RT-PCR (Reverse transcription polymerase chain reaction), a test that detects the presence of viral antigen in nasal and oropharyngeal secretions or chest tomography typical of COVID-19 according to radiological standardization for COVID-19 cases (Machnicki, 2021);
• Pulmonary involvement with persistent disease identified on high-resolution computed tomography of the chest;
• Reduction in DLCO (percentage of predicted), with measurements less than or equal to 80%.

You may not qualify if:

• Previous diagnosis of pulmonary embolism;
• Previous and decompensated heart failure with electrocardiographic changes, chest X-ray with increased cardiac silhouette, and signs in the clinical examination suggestive of heart failure;
• History of acute myocardial infarction in the last month or angina pectoris; Absolute contraindications to the use of corticosteroids or other comorbidities that prevent the use of corticosteroids such as uncontrolled diabetes, untreated glaucoma, current infections such as pneumonia or tuberculosis, and untreated psychiatric disorders;
• Pregnancy and lactation;
• Inability to perform stress tests such as walking tests and spirometry due to critically ill neuropathy or sequelae of stroke, among other limiting pathologies.
• The patient will be informed of the risks related to corticosteroid treatment, and this information will be included in the consent form.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, 14015-010, Brazil

Location

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Related Links

• Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36) / Brazilian-Portuguese version of the SF-36. A reliable and valid quality of life outcome measure

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Elcio O. Vianna, Professor

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Numbers 1 to 100 were randomly mixed up using a computer randomizer program. The first fifty were allocated as placebo and the last fifty as Treatment. Included patients received a number consecutively from 1 to 100. Only one researcher (EOV) knew to which group every number (patient) belonged, placebo or treatment. This researcher labeled medicine vials accordingly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: The study will be conducted at the Hospital das Clínicas of the Ribeirão Preto School of Medicine of the University of São Paulo. It will be a randomized, double-blind, placebo-controlled study of patients who had pneumonia caused by the novel coronavirus and were treated as outpatients, hospitalized, or who required oxygen therapy or orotracheal intubation. After 12 to 20 weeks of the diagnosis of pneumonia caused by the new coronavirus patients will be a standardized time. A medical evaluation, laboratory, imaging, and functional tests will be carried out with a view to immediate entry into the study. This will be considered the first visit. Patients will be randomized, and treatment will be given on the first visit. The evaluations will be carried out on this first visit (baseline) and will be repeated after 3 and 6 months from the first visit. The recruitment period will be 12 months, and the follow-up period for each patient will be 9 months.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: February 2, 2026
• Study Start: August 10, 2021
• Primary Completion: June 9, 2022
• Study Completion: December 12, 2022
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)