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Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 (NORCOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Tracking Information
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
 (submitted: August 31, 2020)
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.
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

  • 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 0.75mg / Kg / d 4week; 0.5mg / Kg / d 4 weeks; 20mg / d 4 weeks; 10mg / d 6 weeks; 5mg / d 6 weeks (6m).
  2. 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.
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
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE Drug: Prednisone
Patients will be randomized 1: 1 between the two arms of the study
Study Arms  ICMJE
  • Active Comparator: Control Group
    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)
    Intervention: Drug: Prednisone
  • Active Comparator: 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.
    Intervention: Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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