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

Phase 3

Completed

• Conditions: Coronavirus Infection
• Interventions: Drug: DEXAMETHASONE; Drug: PREDNISOLONE

• Registration Number: NCT04765371
• Lead Sponsor: Hôpital NOVO

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.

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Study Start: 2021-03-03
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Status Verified: 2022-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXAMETHASONE Arm	DEXAMETHASONE	Patients will take 6 mg per day of Dexamethasone during 10 days
PREDNISOLONE Arm	PREDNISOLONE	Patients will take 60 mg per day of Prednisolone during 10 days

Primary Outcome Measures

Name	Time	Method
Mortality assessment at D28	At Day 28	Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms

Secondary Outcome Measures

Name	Time	Method
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
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
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
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))
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

Trial Locations

Locations (8)

Department of Infectious Medicine, Hospital of Gonesse; 🇫🇷 Gonesse, France

Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin; 🇫🇷 Saint-Quentin, 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 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