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 :
Not yet recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 Pneumonia | Drug: Prednisone | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
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 |
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 |
Estimated Study Start Date : | September 7, 2020 |
Estimated Primary Completion Date : | May 2, 2021 |
Estimated Study Completion Date : | December 15, 2021 |

Arm | Intervention/treatment |
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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)
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Drug: Prednisone
Patients will be randomized 1: 1 between the two arms of the study |
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.
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Drug: Prednisone
Patients will be randomized 1: 1 between the two arms of the study |
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534478
Contact: Maria-Jesus Cruz, PhD | 0034934894048 | mj.cruz@vhir.org |
Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
ClinicalTrials.gov Identifier: | NCT04534478 |
Other Study ID Numbers: |
2020-003651-15 |
First Posted: | September 1, 2020 Key Record Dates |
Last Update Posted: | September 1, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Prednisone Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |