Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia
NCT04359511 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2021-05-12
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 improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an organizing phase of diffuse alveolar damage (DAD).
We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could help to individualize patients with a high probability of pulmonary organizing process who could benefit from CS treatment.
Conditions
Interventions
- DRUG
-
prednisone 0.7 mg/kg/d (PO)
- DRUG
-
Hydrocortisone
hémisuccinate d'hydrocortisone 3,5 mg/kg/jour (IV)
Sponsors & Collaborators
-
University Hospital, Tours
lead OTHER
Principal Investigators
-
LOUIS BERNARD, MD, PhD · CHRU DE TOURS
-
JOUNEAU STEPHANE, MD, PhD · Rennes University Hospital
-
MAILLOT FRANCOIS, MD · CHRU DE TOURS
-
LIOGER BERTRAND, MD · CH DE BLOIS
-
GOUPIL FRANCOIS, MD · CH Le Mans
-
RABUT Thi- Tuyet Hong, MD · CH DE CHARTRES
-
POPA Mihai, MD · CH DE RDREUX
-
MOREL HUGUES, MD · CHR ORLEANS
-
GUY TIPHAINE, MD · CH DE VANNES
-
LEMMENS BRUNO, MD · CH AMBOISE
-
BAZIN YANN, MD · CH SAINT MALO
-
ROY XAVIER, MD · CH DE CHATEAUROUX
-
PECQUERIAUX OLIVIER, MD · CH DE BOURGES
-
MARCHAND ADAM Sylvain, MD, PhD · CHRU DE TOURS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-03
- Primary Completion
- 2020-07-03
- Completion
- 2020-07-03
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