Status:
WITHDRAWN
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia
Lead Sponsor:
University Hospital, Tours
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improv...
Detailed Description
"Severe acute respiratory syndrome" coronavirus 2 (SARS-Cov-2) is a new coronavirus that induces pneumonia called Corona Virus Disease- 19 (COVID-19), an infected 1.5 million people worldwide and caus...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years old,
- Hospitalized with a proven diagnosis of COVID-19 (SARS-CoV-2 positive in RTPCR), in medicine or in intensive care.
- With a need for oxygen therapy ≥ 2 l / min to maintain a Sp02\> 92% or a need for oxygen therapy to maintain a PaO2 / FiO2\> 300 mmHg (for intubated patients).
- With a chest scanner at least 7 days after the onset of symptoms, and whose centralized interpretation shows a CT scan aspect suggestive of intense and predominant DAD which can explain the patient's oxygen dependence.
- Signature of a free, written and informed consent by the patient, or the person of trust
- Affiliate or beneficiary of a social security scheme.
Exclusion
- Patients already treated by CS for a chronic disease.
- Patients with a known contraindication to SC, such as hypersensitivity.
- Patients at risk of dying within 48 hours.
- Pregnant or breastfeeding women.
- Patients under guardianship, curatorship, safeguard of justice.
- Poor understanding of the French language.
Key Trial Info
Start Date :
July 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04359511
Start Date
July 3 2020
End Date
July 3 2020
Last Update
May 12 2021
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