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

Coronavirus Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765371
• Other study ID #: CHRD1520
• Secondary ID: 2020-005883-78
• Status: Completed
• Phase: Phase 3
• Start date: March 3, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: May 2022
• Source: Hôpital NOVO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19

Intervention

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

Locations

Country	Name	City	State
France	Department of Emergency, Hospital Victor Dupouy	Argenteuil
France	Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise	Beaumont
France	Department of Infectious and Tropical Diseases, Hospital Simone Veil	Eaubonne
France	Department of Infectious Medicine, Hospital of Gonesse	Gonesse
France	Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay	Le Puy-en-Velay
France	Department of Infectious and Tropical Diseases, Hospital René Dubos,	Pontoise
France	Department of Infectious and respiratory Diseases, Hospital Delafontaine	Saint-Denis
France	Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin	Saint-Quentin

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality assessment at D28	Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms	At Day 28
Secondary	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))	At Day 28
Secondary	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	From Day 0 to Day 28
Secondary	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	At Day 28
Secondary	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	At Day 1 and Day 28
Secondary	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	At Day 28