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

Primary Purpose

Coronavirus Infection

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
DEXAMETHASONE
PREDNISOLONE
Sponsored by
Hôpital NOVO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring Coronavirus Infections, SARS-CoV-2, Corticostéroïdes, Severe form of COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Emergency, Hospital Victor Dupouy
  • Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise
  • Department of Infectious and Tropical Diseases, Hospital Simone Veil
  • Department of Infectious Medicine, Hospital of Gonesse
  • Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay
  • Department of Infectious and Tropical Diseases, Hospital René Dubos,
  • Department of Infectious and respiratory Diseases, Hospital Delafontaine
  • Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DEXAMETHASONE Arm

PREDNISOLONE Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of clinical course in both groups (arms)
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))
Measurement of evolution of respiratory symptoms in both groups (arms)
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
Assessment of patient satisfaction towards the treatment
Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale) For each item, patient ticks : Very satisfied, Satisfied, Unsatisfied or Very unsatisfied
Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)
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
Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)
Measurement of adverse events number and adverse effects number during the 28 days of the study

Full Information

First Posted
February 18, 2021
Last Updated
May 20, 2022
Sponsor
Hôpital NOVO
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1. Study Identification

Unique Protocol Identification Number
NCT04765371
Brief Title
Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, With CoViD-19
Acronym
COPreDex
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital NOVO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
Keywords
Coronavirus Infections, SARS-CoV-2, Corticostéroïdes, Severe form of COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEXAMETHASONE Arm
Arm Type
Active Comparator
Arm Description
Patients will take 6 mg per day of Dexamethasone during 10 days
Arm Title
PREDNISOLONE Arm
Arm Type
Active Comparator
Arm Description
Patients will take 60 mg per day of Prednisolone during 10 days
Intervention Type
Drug
Intervention Name(s)
DEXAMETHASONE
Other Intervention Name(s)
DEXAMETHASONE Arm
Intervention Description
Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
Intervention Type
Drug
Intervention Name(s)
PREDNISOLONE
Other Intervention Name(s)
PREDNISOLONE Arm
Intervention Description
Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
Primary Outcome Measure Information:
Title
Mortality assessment at D28
Description
Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms
Time Frame
At Day 28
Secondary Outcome Measure Information:
Title
Assessment of clinical course in both groups (arms)
Description
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))
Time Frame
At Day 28
Title
Measurement of evolution of respiratory symptoms in both groups (arms)
Description
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
Time Frame
From Day 0 to Day 28
Title
Assessment of patient satisfaction towards the treatment
Description
Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale) For each item, patient ticks : Very satisfied, Satisfied, Unsatisfied or Very unsatisfied
Time Frame
At Day 28
Title
Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)
Description
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
Time Frame
At Day 1 and Day 28
Title
Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)
Description
Measurement of adverse events number and adverse effects number during the 28 days of the study
Time Frame
At Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Edouard DEVAUD
Organizational Affiliation
Hôpital NOVO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Emergency, Hospital Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise
City
Beaumont
Country
France
Facility Name
Department of Infectious and Tropical Diseases, Hospital Simone Veil
City
Eaubonne
ZIP/Postal Code
95600
Country
France
Facility Name
Department of Infectious Medicine, Hospital of Gonesse
City
Gonesse
ZIP/Postal Code
95500
Country
France
Facility Name
Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay
City
Le Puy-en-Velay
ZIP/Postal Code
43012
Country
France
Facility Name
Department of Infectious and Tropical Diseases, Hospital René Dubos,
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Department of Infectious and respiratory Diseases, Hospital Delafontaine
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin
City
Saint-Quentin
ZIP/Postal Code
02321
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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