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

NCT04534478 | Unknown Phase 4

• 1 other identifier: 2020-003651-15
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  Six Months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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)

Drug: Prednisone

Experimental group

ACTIVE COMPARATOR

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.

Drug: Prednisone

Interventions

Prednisone DRUG

Patients will be randomized 1: 1 between the two arms of the study

Control Group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Maria-Jesus Cruz, PhD

CONTACT

0034934894048; mj.cruz@vhir.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel clinical trial with therapeutic intervention, randomized, open and controlled, of non-inferiority

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 1, 2020
• Study Start: September 7, 2020
• Primary Completion: May 2, 2021
• Study Completion: December 15, 2021
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share