COPreDex: Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, With CoViD-19

Sponsor
Centre Hospitalier René Dubos (Other)
Overall Status
Completed
CT.gov ID
NCT04765371
Collaborator
(none)
89
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2
14.3
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Study Details

Study Description

Brief Summary

The aim of the study is to evaluate two differents regimens of corticosteroids (prednisolone versus dexamethasone) on D28 mortality in patients with CoViD 19 pneumonia requiring oxygen supplementation

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Low-dose glucocorticoid treatment is the only medication showing a significant reduction in mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support.

Intravenous or oral dexamethasone are well evaluated in randomized study but other oral corticosteroids are not. Compared to dexamethasone, prednisolone is more available in France and easily taken by patients, especially in case of home medical care.

The pharmacokinetics/pharmacodynamics of prednisolone and dexamethasone are different. To obtain similar effects, prednisolone should be theoretically taken twice a day and at a superior dose than the strict prednisone equivalence of 6mg dexamethasone.

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study
Actual Study Start Date :
Mar 3, 2021
Actual Primary Completion Date :
Feb 10, 2022
Actual Study Completion Date :
May 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: DEXAMETHASONE Arm

Patients will take 6 mg per day of Dexamethasone during 10 days

Drug: DEXAMETHASONE
Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
Other Names:
  • DEXAMETHASONE Arm
  • Active Comparator: PREDNISOLONE Arm

    Patients will take 60 mg per day of Prednisolone during 10 days

    Drug: PREDNISOLONE
    Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
    Other Names:
  • PREDNISOLONE Arm
  • Outcome Measures

    Primary Outcome Measures

    1. Mortality assessment at D28 [At Day 28]

      Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms

    Secondary Outcome Measures

    1. Assessment of clinical course in both groups (arms) [At Day 28]

      The clinical course for each patient will be measured, for several items, and compared between both groups to see if a significant difference is observed. Items, considered for comparison, are listed below : Number of oxygen therapy days, Number of patients requiring oxygen therapy increase (High-Flow Oxygen Therapy, CPAP/BIPAP, mechanical ventilation, ECMO) Number of hospital days Number of patient admitted in Resuscitation Unit /Intensive care Unit Number of patient with organic damage other than lung Number of disease-related infection other than SARS-Cov-2 Frequency and evolution of complication of corticosteroid therapy (Severity evaluated according to CTCAE (diabetes, acute psychosis or other adverse effect consider to be link to corticosteroide therapy by investigator))

    2. Measurement of evolution of respiratory symptoms in both groups (arms) [From Day 0 to Day 28]

      Evolution of respiratory symptoms will be measured for each patient, for several items, and compared between both groups to see if a significant difference is observed. Items, considered for comparison, are listed below : Oxygen saturation rate, Oxygen flow, Respiratory rate

    3. Assessment of patient satisfaction towards the treatment [At Day 28]

      Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale) For each item, patient ticks : Very satisfied, Satisfied, Unsatisfied or Very unsatisfied

    4. Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms) [At Day 1 and Day 28]

      Measurement of patient quality of life evolution with EQ5D self-assessment questionnaire at day1 and day 28. For item of mobility, autonomy and current activities, patient ticks : I have no problem, I have some problems or I am I am unable to do For item of pain and anxiety/depression, patient ticks : no, moderate or severe

    5. Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms) [At Day 28]

      Measurement of adverse events number and adverse effects number during the 28 days of the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient ≥ 18 years old

    • Patient with SARS-CoV-2 pneumopathy documented by nasopharyngeal or bronchoalveolar lavage fluid RT-PCR or any documented clinical symptoms support by CT scan

    • Patient with SpaO2 ≤ 94 % in room air (90% for patient with respiratory failure) and requiring an oxygen therapy

    • Negative pregnancy test for women of childbearing age

    • Informed and written informed consent (IC) obtained

    • Patients with affiliation to the social security system

    Exclusion Criteria:
    • Patient with corticosteroids as background treatment (≥ 10 mg equivalent)

    • Patient under supplemental oxygen > 6 L/min

    • Immunocompromised patient (AIDS, bone marrow or solid organ transplants, etc.)

    • Patient who received a corticosteroid dose within 3 days for Covid-19

    • Medical history of hypersensitivity to Prednisolone or Dexamethasone; or lactose / galactose (excipients with known effect)

    • Another active virus such hepatitis, herpes, varicella, shingles ….

    • Psychotic state not controlled by treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Emergency, Hospital Victor Dupouy Argenteuil France 95100
    2 Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise Beaumont France
    3 Department of Infectious and Tropical Diseases, Hospital Simone Veil Eaubonne France 95600
    4 Department of Infectious Medicine, Hospital of Gonesse Gonesse France 95500
    5 Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay Le Puy-en-Velay France 43012
    6 Department of Infectious and Tropical Diseases, Hospital René Dubos, Pontoise France 95300
    7 Department of Infectious and respiratory Diseases, Hospital Delafontaine Saint-Denis France 93200
    8 Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin Saint-Quentin France 02321

    Sponsors and Collaborators

    • Centre Hospitalier René Dubos

    Investigators

    • Principal Investigator: Dr Edouard DEVAUD, Centre Hospitalier René Dubos

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier René Dubos
    ClinicalTrials.gov Identifier:
    NCT04765371
    Other Study ID Numbers:
    • CHRD1520
    • 2020-005883-78
    First Posted:
    Feb 21, 2021
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier René Dubos
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 23, 2022