Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia

NCT04359511 | Withdrawn Phase 3

• 2 other identifiers: CORTI-COVID-19-HUGODR200136
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days.

  The 7-category ordinal scale is as follow: 1. Not hospitalized with resumption of usual activities 2. Not hospitalized, but unable to resume usual activities 3. Hospitalized, not requiring O2 4. Hospitalized, requiring O2 from 1 to 5 l/min 5. Hospitalized, requiring O2 \>6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death.

  14 days

Secondary Outcomes (7)

• Proportion of patients free of oxygen at day 14 and 28

  14 and 28 days

• Proportion of patients discharged alive from hospital at day 14 and 28

  14 and 28 days

• Time to discharge for patients alive

  28 days

• Proportion of patients that were hospitalized to ICU or who died at day 14 and 28

  14 and 28 days

• 14 and 28 day mortality rate

  14 and 28 days

Study Arms (2)

corticosteroid + Optimized Standard of Care

EXPERIMENTAL

* prednisone 0.7 mg/kg/day for 10 days, administered orally, once a day, or * hydrocortisone hemisuccinate 3.5 mg/kg/day by continuous infusion for 10 days, administered by IV route if the patient cannot take drugs by oral route, * standard of care

Drug: Prednisone; Drug: Hydrocortisone

Optimized Standard of Care

NO INTERVENTION

standard of care

Interventions

Prednisone DRUG

prednisone 0.7 mg/kg/d (PO)

corticosteroid + Optimized Standard of Care

Hydrocortisone DRUG

hémisuccinate d'hydrocortisone 3,5 mg/kg/jour (IV)

corticosteroid + Optimized Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead

MeSH Terms

Conditions

COVID-19

Interventions

Prednisone; Hydrocortisone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• LOUIS BERNARD, MD, PhD

  CHRU DE TOURS

  PRINCIPAL INVESTIGATOR

• JOUNEAU STEPHANE, MD, PhD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• MAILLOT FRANCOIS, MD

  CHRU DE TOURS

  PRINCIPAL INVESTIGATOR

• LIOGER BERTRAND, MD

  CH DE BLOIS

  PRINCIPAL INVESTIGATOR

• GOUPIL FRANCOIS, MD

  CH Le Mans

  PRINCIPAL INVESTIGATOR

• RABUT Thi- Tuyet Hong, MD

  CH DE CHARTRES

  PRINCIPAL INVESTIGATOR

• POPA Mihai, MD

  CH DE RDREUX

  PRINCIPAL INVESTIGATOR

• MOREL HUGUES, MD

  CHR ORLEANS

  PRINCIPAL INVESTIGATOR

• GUY TIPHAINE, MD

  CH DE VANNES

  PRINCIPAL INVESTIGATOR

• LEMMENS BRUNO, MD

  CH AMBOISE

  PRINCIPAL INVESTIGATOR

• BAZIN YANN, MD

  CH SAINT MALO

  PRINCIPAL INVESTIGATOR

• ROY XAVIER, MD

  CH DE CHATEAUROUX

  PRINCIPAL INVESTIGATOR

• PECQUERIAUX OLIVIER, MD

  CH DE BOURGES

  PRINCIPAL INVESTIGATOR

• MARCHAND ADAM Sylvain, MD, PhD

  CHRU DE TOURS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: July 3, 2020
• Primary Completion: July 3, 2020
• Study Completion: July 3, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05