Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534478
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-31
Brief Title:
Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Randomized Open Parallel Single-center Non-inferiority Clinical Trial With an Active Control Group Comparing Two Oral Prednisone Regimens With the Aim of Optimizing the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 Infection
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
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:
NORCOVID
Brief Summary:
Background Based on data from the 2003 SARS-COVID pandemic other serious lung infections and patients with respiratory distress it is estimated that 10-30 of patients with severe SARS-COVID-2 pneumonia may present as a sequel an organized pneumonia The treatment of this complication is not well defined The use of oral corticosteroids is mandatory to avoid a possible evolution to pulmonary fibrosis however the doses to be administered and the duration of treatment are unknown as there is no study specifically aimed at solving this doubt Many authors advocate high-dose treatment regimens for a minimum of six months as proposed for cryptogenic organized pneumonia However there is a question whether in non-idiopathic cases of organized pneumonia less intense treatment could resolve the disease Hypothesis The use of a less intensive prednisone regimen may be sufficient for therapeutic control in patients with post-COVID-19 organizing pneumonia in relation to the established standard regimen Simplicity of the procedures The objective of the NORCOVID study is to identify the optimal treatment regimen with corticosteroids in post-COVID19 patients diagnosed with NO Specifically the primary objective of this multicenter randomized trial is to evaluate whether treatment with a less intensive regimen of corticosteroids produces a non-inferior therapeutic effect than the established control regimen Secondary objectives are to evaluate the effect of treatment on secondary efficacy variables and on safety DLCO respiratory function tests 6MWT test need for rescue radiological tests complications mortality and the WHO ordinal scale will be evaluated
Detailed Description:
Hypothesis The use of a less intensive prednisone regimen may be sufficient for therapeutic control in patients with post-COVID-19 organizing pneumonia in relation to the established standard regimen
Objectives The objective of the NORCOVID study is to identify the optimal treatment regimen with corticosteroids in post-COVID19 patients diagnosed with NO Specifically the primary objective of this multicenter randomized trial is to evaluate whether treatment with a less intensive regimen of corticosteroids produces a non-inferior therapeutic effect than the established control regimen Secondary objectives are to evaluate the effect of treatment on secondary efficacy variables and on safety DLCO respiratory function tests 6MWT test need for rescue radiological tests complications mortality and the WHO ordinal scale will be evaluated
Study population inclusion and exclusion criteria
Inclusion criteria 1 Patients over 18 years of age 2 Diagnosis of COVID-19 pneumonia that would have required hospital admission 3 Diagnosis of post-COVID-19 organized pneumonia 4 Without any contraindication to the study drug 5 That properly informed voluntarily agree to participate in the study after knowing its objectives and risks and give their consent
Exclusion criteria Patients will not be randomized if 1 They do not authorize their participation 2 Patients with contraindications to receiving corticosteroid treatment 3 Impossibility of understanding the requirements of the study in the opinion of the investigator 4 Expected survival less than the duration of the study in the opinion of the investigator 5 Clinical evidence of active infection including but not limited to bronchitis pneumonia sinusitis urinary tract infection and or cellulitis 6 Patient who is subject to receiving a lung transplant during the study period 7 Impossibility of conducting lung function studies 8 Poorly controlled diabetes mellitus glycosylated Hb 10 9 Pregnancy or breastfeeding 10 Have any contraindication to the study drug 11 Are participating in another intervention study
Products evaluated and administration regimens
The product evaluated will be Prednisone orally in two administration schedules
1 Control Group Prednisone 075mg Kg d 4week 05mg Kg d 4 weeks 20mg d 4 weeks 10mg d 6 weeks 5mg d 6 weeks 6m
2 Experimental Group Prednisone 05mg Kg d 3 weeks 20mg day 3 weeks 15mg day 2 weeks 10mg day 2 weeks 5mg day 2 weeks and discontinue
Main variable - The main variable will be the change in pulmonary diffusion in terms of predicted DLCO between the baseline value and that obtained at 6 months comparing the two treatment groups adjusting for the baseline value using a model of Repeated measures with random effects mixed model for repeated measurements MMRM
Secondary variables
DLCO in original units DLCO10s mLmin - 1mmHg - 1
Percentage of patients with values 80 predicted
Respiratory function tests
6-Minute-Walk Test 6MWT test
Need for rescue
Computed Axial Tomography Test
Complications related to the evolution of the disease serious and non-serious
Complications related to corticosteroid treatment serious and non-serious
Complication of any kind serious and non-serious
Mortality from any cause
Ordinal variable of clinical improvement recommended by the WHO RD Blueprint expert group15 for the acute phase The worst score obtained during the study will be evaluated at each visit and as a summary measure
Objectives The objective of the NORCOVID study is to identify the optimal treatment regimen with corticosteroids in post-COVID19 patients diagnosed with NO Specifically the primary objective of this multicenter randomized trial is to evaluate whether treatment with a less intensive regimen of corticosteroids produces a non-inferior therapeutic effect than the established control regimen Secondary objectives are to evaluate the effect of treatment on secondary efficacy variables and on safety DLCO respiratory function tests 6MWT test need for rescue radiological tests complications mortality and the WHO ordinal scale will be evaluated
Study population inclusion and exclusion criteria
Inclusion criteria 1 Patients over 18 years of age 2 Diagnosis of COVID-19 pneumonia that would have required hospital admission 3 Diagnosis of post-COVID-19 organized pneumonia 4 Without any contraindication to the study drug 5 That properly informed voluntarily agree to participate in the study after knowing its objectives and risks and give their consent
Exclusion criteria Patients will not be randomized if 1 They do not authorize their participation 2 Patients with contraindications to receiving corticosteroid treatment 3 Impossibility of understanding the requirements of the study in the opinion of the investigator 4 Expected survival less than the duration of the study in the opinion of the investigator 5 Clinical evidence of active infection including but not limited to bronchitis pneumonia sinusitis urinary tract infection and or cellulitis 6 Patient who is subject to receiving a lung transplant during the study period 7 Impossibility of conducting lung function studies 8 Poorly controlled diabetes mellitus glycosylated Hb 10 9 Pregnancy or breastfeeding 10 Have any contraindication to the study drug 11 Are participating in another intervention study
Products evaluated and administration regimens
The product evaluated will be Prednisone orally in two administration schedules
1 Control Group Prednisone 075mg Kg d 4week 05mg Kg d 4 weeks 20mg d 4 weeks 10mg d 6 weeks 5mg d 6 weeks 6m
2 Experimental Group Prednisone 05mg Kg d 3 weeks 20mg day 3 weeks 15mg day 2 weeks 10mg day 2 weeks 5mg day 2 weeks and discontinue
Main variable - The main variable will be the change in pulmonary diffusion in terms of predicted DLCO between the baseline value and that obtained at 6 months comparing the two treatment groups adjusting for the baseline value using a model of Repeated measures with random effects mixed model for repeated measurements MMRM
Secondary variables
DLCO in original units DLCO10s mLmin - 1mmHg - 1
Percentage of patients with values 80 predicted
Respiratory function tests
6-Minute-Walk Test 6MWT test
Need for rescue
Computed Axial Tomography Test
Complications related to the evolution of the disease serious and non-serious
Complications related to corticosteroid treatment serious and non-serious
Complication of any kind serious and non-serious
Mortality from any cause
Ordinal variable of clinical improvement recommended by the WHO RD Blueprint expert group15 for the acute phase The worst score obtained during the study will be evaluated at each visit and as a summary measure
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