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

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

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.

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