Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 (NORCOVID)
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ClinicalTrials.gov Identifier: NCT04534478 |
Recruitment Status : Unknown
Verified August 2020 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was: Not yet recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | August 31, 2020 | ||||
First Posted Date ICMJE | September 1, 2020 | ||||
Last Update Posted Date | September 1, 2020 | ||||
Estimated Study Start Date ICMJE | September 7, 2020 | ||||
Estimated Primary Completion Date | May 2, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in pulmonary diffusion. [ Time Frame: Six Months ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 | ||||
Official Title ICMJE | 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 | ||||
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
Products evaluated and administration regimens. The product evaluated will be Prednisone orally in two administration schedules:
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
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Parallel clinical trial with therapeutic intervention, randomized, open and controlled, of non-inferiority Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | COVID-19 Pneumonia | ||||
Intervention ICMJE | Drug: Prednisone
Patients will be randomized 1: 1 between the two arms of the study
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
120 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 15, 2021 | ||||
Estimated Primary Completion Date | May 2, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04534478 | ||||
Other Study ID Numbers ICMJE | 2020-003651-15 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Hospital Universitari Vall d'Hebron Research Institute | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Hospital Universitari Vall d'Hebron Research Institute | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Hospital Universitari Vall d'Hebron Research Institute | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |