Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04657484
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2020-12-05
Brief Title:
Comparison of Two Corticosteroid Regimens for Post COVID-19 Diffuse Lung Disease
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Comparison of the Efficacy and Safety of Two Corticosteroid Regimens in the Treatment of Diffuse Lung Disease After Coronavirus Disease 2019 COVID-19 Pneumonia
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLDSTER
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
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
Detailed Description:
A proportion of patients with COVID-19 pneumonia with or without ARDS 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 even after the symptoms of active COVID-19 have subsided and swabs from the upper respiratory tract for SARS-CoV-2 have turned negative Such patients may be classified as having a secondary form of OP namely post-infectious OP Some of the patients also start developing signs of fibrosis
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
Glucocorticoids may be a double-edged sword in this clinical situation Steroids reduce inflammation associated with OP with a resultant resolution of symptoms improvement in gas exchange resulting in the resolution of hypoxemia and potentially preventing the progression of early parenchymal abnormalities to irreversible fibrosis However they are associated with adverse effects such as hyperglycemia delayed viral clearance and increased susceptibility to infections The ideal dose of glucocorticoids for treating PC-DLD is unknown As PC-DLD is likely to get recognised early much earlier than the average duration between onset of symptoms and diagnosis in other forms of OP ie about 3-6 months there is a possibility a lower intensity of glucocorticoids may be sufficient for treatment than the usual regimens with the advantage of lesser adverse effects A previous retrospective study that compared two regimens higher dose intensity DI of glucocorticoids alone vs glucocorticoids at a lower dose intensity along with clarithromycin however found that a complete radiologic response was higher in the prednisone alone higher DI group 81 vs 63 than in the combination group with a lower DI of prednisone Statistical significance was however not achieved p038 mainly due to the small sample size
The investiagtors hypothesize that in PC-DLD a higher intensity ie starting with a medium dose of prednisolone will be more effective than a lower dose intensity ie starting with a low dose of prednisolone of glucocorticoids in effecting a radiologic response at six weeks
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
Glucocorticoids may be a double-edged sword in this clinical situation Steroids reduce inflammation associated with OP with a resultant resolution of symptoms improvement in gas exchange resulting in the resolution of hypoxemia and potentially preventing the progression of early parenchymal abnormalities to irreversible fibrosis However they are associated with adverse effects such as hyperglycemia delayed viral clearance and increased susceptibility to infections The ideal dose of glucocorticoids for treating PC-DLD is unknown As PC-DLD is likely to get recognised early much earlier than the average duration between onset of symptoms and diagnosis in other forms of OP ie about 3-6 months there is a possibility a lower intensity of glucocorticoids may be sufficient for treatment than the usual regimens with the advantage of lesser adverse effects A previous retrospective study that compared two regimens higher dose intensity DI of glucocorticoids alone vs glucocorticoids at a lower dose intensity along with clarithromycin however found that a complete radiologic response was higher in the prednisone alone higher DI group 81 vs 63 than in the combination group with a lower DI of prednisone Statistical significance was however not achieved p038 mainly due to the small sample size
The investiagtors hypothesize that in PC-DLD a higher intensity ie starting with a medium dose of prednisolone will be more effective than a lower dose intensity ie starting with a low dose of prednisolone of glucocorticoids in effecting a radiologic response at six weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None