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NCT04359511 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL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

No results posted yet for this study

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

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359511 on ClinicalTrials.gov