Comparison of Two Corticosteroid Regimens for Post COVID-19 Diffuse Lung Disease

NCT04657484 | Completed

• 1 other identifier: INT/IEC/2020/SPL-1528
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

A proportion of patients with COVID-19 pneumonia have a prolonged course of illness. Some of these patients continue to have considerable respiratory symptoms or persistent hypoxemia. The CT abnormalities in these patients are often a combination of ground-glass opacities and patchy multifocal consolidation consistent with a pattern of OP. In several patients, these radiologic abnormalities persist. As with other forms of OP, patients with post-COVID OP or post COVID diffuse lung disease (PC-DLD) may benefit from treatment with oral glucocorticoids. The ideal dose of glucocorticoids for treating PC-DLD is unknown. In this study, the investigatros aim to compare the efficacy and safety of a medium dose and a low dose of prednisolone (as the initial dose) for the treatment of post-COVID. diffuse lung disease.

Conditions

Post COVID-19 Diffuse Lung Disease

Keywords

diffuse parenchymal lung disease; interstitial lung disease; organizing pneumonia; coronavirus disease-2019; SARS-Co-V-2

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with a complete radiologic response

  Complete response is defined as complete disappearance or ≥90% reduction in the lung parenchymal abnormalities on a high-resolution CT scan

  6 weeks

Secondary Outcomes (10)

• Proportion of subjects with a complete or good response radiologic response

  6 weeks

• Proportion of subjects with a good composite response

  6 weeks

• Forced vital capacity as a percentage of the predicted

  6 weeks

• Change in resting oxygen saturation

  6 weeks

• Proportion of subjects with oxygen desaturation on exercise testing

  6 weeks

Study Arms (2)

Medium dose prednisolone

ACTIVE COMPARATOR

An initial dose of 40 mg/day will be administered for 1 week, followed by 30 mg/day for 1 week, 20 mg/day for 2 weeks, 10 mg/day for 2 weeks

Drug: Medium dose prednisolone

Low dose prednisolone

ACTIVE COMPARATOR

A dose of 10 mg/day of prednisolone will be administered for 6 weeks

Drug: Low dose prednisolone

Interventions

Medium dose prednisolone DRUG

Same as arm description

Medium dose prednisolone

Low dose prednisolone DRUG

Same as arm description

Low dose prednisolone

Eligibility Criteria

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

You may qualify if:

• Diagnosed to have COVID-19 by means of a real-time reverse transcription polymerase chain reaction (rRT-PCR) test performed on a respiratory (upper or lower respiratory) sample or the detection of COVID-19 antigen
• Having significant respiratory symptoms (cough and breathlessness) or persistent hypoxemia or oxygen desaturation on exercise and CT chest showing residual changes of post-COVID parenchymal involvement of any extent OR having CT chest showing residual changes of post-COVID parenchymal involvement \>20% of the lung parenchyma on visual inspection of the scans between 3-8 weeks of the onset of symptoms of COVID-19
• Willing to participate in the study

You may not qualify if:

• Receiving ventilatory or respiratory support (invasive or non-invasive mechanical ventilation or high flow nasal cannula) or supplemental oxygen with FiO2\>0.35
• Requiring intensive care due to acute COVID-19 pneumonia or its complications
• Having a known lung parenchymal lung disease before the onset of COVID-19
• Pregnant or lactating women
• Having absolute contraindication for prednisolone in a dose of 40 mg/day (this includes untreated glaucoma, uncontrolled diabetes mellitus, signs of an uncontrolled or untreated infection or sepsis, pulmonary mycosis, untreated severe psychiatric disorders)
• Unwilling to provide informed consent

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (1)

• Dhooria S, Chaudhary S, Sehgal IS, Agarwal R, Arora S, Garg M, Prabhakar N, Puri GD, Bhalla A, Suri V, Yaddanapudi LN, Muthu V, Prasad KT, Aggarwal AN. High-dose versus low-dose prednisolone in symptomatic patients with post-COVID-19 diffuse parenchymal lung abnormalities: an open-label, randomised trial (the COLDSTER trial). Eur Respir J. 2022 Feb 17;59(2):2102930. doi: 10.1183/13993003.02930-2021. Print 2022 Feb.

  PMID: 34887325 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial; Organizing Pneumonia

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 8, 2020
• Study Start: December 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

IN (1)