Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 (NORCOVID)
Primary Purpose
COVID-19 Pneumonia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years of age
- Diagnosis of COVID-19 pneumonia that would have required hospital admission
- Post COVID-19 Organized Pneumonia Diagnosis
- Without any contraindication to the study drug
- That, adequately informed, voluntarily agree to participate in the study after knowing its objectives and risks and grant their written consent.
Exclusion Criteria:
- They do not authorize their participation
- Patients with contraindications to receiving treatment with corticosteroids
- Impossibility of understanding the requirements of the study, in the opinion of the researcher.
- Expected survival less than the duration of the study in the opinion of the investigator.
- Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection and / or cellulitis.
- Patient who receives a lung transplant during the study period.
- Impossibility of carrying out lung function studies. - Poorly controlled diabetes mellitus (glycosylated Hb> 10%).
- Pregnancy or breastfeeding
- They are participating in another intervention study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control Group
Experimental group
Arm Description
Prednisone 0.75mg / Kg / d 4 weeks; 0.5mg / Kg / d 4 weeks; 20mg / d 4 weeks; 10mg / d 6 weeks; 5mg / d 6 weeks (6m)
Prednisone 0.5mg / Kg / d 3 weeks, 20mg / day 3 weeks; 15mg / day 2 weeks; 10mg / day 2 weeks, 5mg / day 2 weeks and discontinue.
Outcomes
Primary Outcome Measures
Change in pulmonary diffusion.
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 repeated measures model with random effects (mixed model for repeated measurements.
Secondary Outcome Measures
Full Information
NCT ID
NCT04534478
First Posted
August 31, 2020
Last Updated
August 31, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04534478
Brief Title
Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19
Acronym
NORCOVID
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2020 (Anticipated)
Primary Completion Date
May 2, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Control Group: Prednisone 0.75mg / Kg / d 4week; 0.5mg / Kg / d 4 weeks; 20mg / d 4 weeks; 10mg / d 6 weeks; 5mg / d 6 weeks (6m).
Experimental Group: Prednisone 0.5mg / 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 R&D 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel clinical trial with therapeutic intervention, randomized, open and controlled, of non-inferiority
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Prednisone 0.75mg / Kg / d 4 weeks; 0.5mg / Kg / d 4 weeks; 20mg / d 4 weeks; 10mg / d 6 weeks; 5mg / d 6 weeks (6m)
Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
Prednisone 0.5mg / Kg / d 3 weeks, 20mg / day 3 weeks; 15mg / day 2 weeks; 10mg / day 2 weeks, 5mg / day 2 weeks and discontinue.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Patients will be randomized 1: 1 between the two arms of the study
Primary Outcome Measure Information:
Title
Change in pulmonary diffusion.
Description
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 repeated measures model with random effects (mixed model for repeated measurements.
Time Frame
Six Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years of age
Diagnosis of COVID-19 pneumonia that would have required hospital admission
Post COVID-19 Organized Pneumonia Diagnosis
Without any contraindication to the study drug
That, adequately informed, voluntarily agree to participate in the study after knowing its objectives and risks and grant their written consent.
Exclusion Criteria:
They do not authorize their participation
Patients with contraindications to receiving treatment with corticosteroids
Impossibility of understanding the requirements of the study, in the opinion of the researcher.
Expected survival less than the duration of the study in the opinion of the investigator.
Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection and / or cellulitis.
Patient who receives a lung transplant during the study period.
Impossibility of carrying out lung function studies. - Poorly controlled diabetes mellitus (glycosylated Hb> 10%).
Pregnancy or breastfeeding
They are participating in another intervention study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria-Jesus Cruz, PhD
Phone
0034934894048
Email
mj.cruz@vhir.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19
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