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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier René Dubos
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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