Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, wit… (NCT04765371) | Clinical Trial Compass
CompletedPhase 3
Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, with CoViD-19
France89 participantsStarted 2021-03-03
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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