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

May 3, 2024 updated by: Hôpital NOVO

Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
        • Department of Emergency, Hospital Victor Dupouy
      • Beaumont, France
        • Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise
      • Eaubonne, France, 95600
        • Department of Infectious and Tropical Diseases, Hospital Simone Veil
      • Gonesse, France, 95500
        • Department of Infectious Medicine, Hospital of Gonesse
      • Le Puy-en-Velay, France, 43012
        • Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay
      • Pontoise, France, 95300
        • Department of Infectious and Tropical Diseases, Hospital René Dubos,
      • Saint-Denis, France, 93200
        • Department of Infectious and respiratory Diseases, Hospital Delafontaine
      • Saint-Quentin, France, 02321
        • Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality assessment at D28
Time Frame: At Day 28
Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms
At Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of clinical course in both groups (arms)
Time Frame: 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))
At Day 28
Measurement of evolution of respiratory symptoms in both groups (arms)
Time Frame: 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
From Day 0 to Day 28
Assessment of patient satisfaction towards the treatment
Time Frame: 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
At Day 28
Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)
Time Frame: 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
At Day 1 and Day 28
Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)
Time Frame: At Day 28
Measurement of adverse events number and adverse effects number during the 28 days of the study
At Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital NOVO

Investigators

  • Principal Investigator: Dr Edouard DEVAUD, Hôpital NOVO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

February 10, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD1520
  • 2020-005883-78 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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