NCT04765371.

Study name	Comparison between prednisolone and dexamethasone on mortality in patients on oxygen therapy, with COVID‐19 (COPreDex)
Methods	Trial design: open‐label RCT Sample size: 220 Setting: inpatients Language: French, English Number of centres: 6 Type of intervention (treatment/prevention): treatment
Participants	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, etc. Psychotic state not controlled by treatment
Interventions	Details of intervention Dose: 6 mg/d of dexamethasone during 10 days Route of administration: most likely systemic Treatment details of control group (e.g. dose, route of administration): 60 mg/d of prednisolone during 10 days Concomitant therapy: no information
Outcomes	Primary outcome: mortality assessment at day 28
Starting date	March 2021
Contact information	Maryline Delattre: +33 130754131  Email: maryline.delattre@ght‐novo.fr
Notes	Recruitment status: recruiting Prospective completion date: October 2021 Date last update was posted: 1 March 2021 Sponsor/funding: Centre Hospitalier René Dubos