Status:
COMPLETED
Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, with CoViD-19
Lead Sponsor:
Hôpital NOVO
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Intraveno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04765371
Start Date
March 3 2021
End Date
February 10 2022
Last Update
September 19 2024
Active Locations (8)
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1
Department of Emergency, Hospital Victor Dupouy
Argenteuil, France, 95100
2
Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise
Beaumont, France
3
Department of Infectious and Tropical Diseases, Hospital Simone Veil
Eaubonne, France, 95600
4
Department of Infectious Medicine, Hospital of Gonesse
Gonesse, France, 95500