Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, with CoViD-19

NCT04765371 | Completed Phase 3

• 2 other identifiers: CHRD15202020-005883-78
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 8

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

Conditions

Coronavirus Infection

Keywords

Coronavirus Infections; SARS-CoV-2; Corticostéroïdes; Severe form of COVID-19

Outcome Measures

Primary Outcomes (1)

• Mortality assessment at D28

  Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms

  At Day 28

Secondary Outcomes (5)

• Assessment of clinical course in both groups (arms)

  At Day 28

• Measurement of evolution of respiratory symptoms in both groups (arms)

  From Day 0 to Day 28

• Assessment of patient satisfaction towards the treatment

  At Day 28

• Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)

  At Day 1 and Day 28

• Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)

  At Day 28

Study Arms (2)

DEXAMETHASONE Arm

ACTIVE COMPARATOR

Patients will take 6 mg per day of Dexamethasone during 10 days

Drug: DEXAMETHASONE

PREDNISOLONE Arm

ACTIVE COMPARATOR

Patients will take 60 mg per day of Prednisolone during 10 days

Drug: PREDNISOLONE

Interventions

DEXAMETHASONE DRUG

Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10

Also known as: DEXAMETHASONE Arm

DEXAMETHASONE Arm

PREDNISOLONE DRUG

Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10

Also known as: PREDNISOLONE Arm

PREDNISOLONE Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (8)

Department of Emergency, Hospital Victor Dupouy

Argenteuil, 95100, France

Location

Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise

Beaumont, France

Location

Department of Infectious and Tropical Diseases, Hospital Simone Veil

Eaubonne, 95600, France

Location

Department of Infectious Medicine, Hospital of Gonesse

Gonesse, 95500, France

Location

Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay

Le Puy-en-Velay, 43012, France

Location

Department of Infectious and Tropical Diseases, Hospital René Dubos,

Pontoise, 95300, France

Location

Department of Infectious and respiratory Diseases, Hospital Delafontaine

Saint-Denis, 93200, France

Location

Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin

Saint-Quentin, 02321, France

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Dexamethasone; Prednisolone

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dr Edouard DEVAUD

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: March 3, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: September 19, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)