Comparison of Prednisolone and Dexamethasone on D28 mortality in patients on oxygen therapy with CoViD-19

Phase 1

• Conditions: Care of severe forms of CoViD-19 from the transitional phase and the onset of the inflammatory phase with corticosteroids; MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: LLTClassification code 10042839Term: Syndrome respiratory distress adultSystem Organ Class: 100000004855; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005883-78-FR
• Lead Sponsor: Hospital Center rené Dubos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-23
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

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 under supplemental oxygen with a measuring SPO2 = 94 % or = 90 % for patient with respiratory comorbidity
Informed and written informed consent (IC) obtained
Patients with affiliation to the social security system
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion Criteria

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
Pregnant and breast-feeding women
Vulnerable populations (guardianship or trusteeship)
Taking corticosteroids contraindication (allergy ….)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Mortality assessment at D28;Secondary Objective: Evolution of respiratory symptoms in both groups <br>Assessment of patient satisfaction towards the treatment<br>Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups <br>Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups <br>;Primary end point(s): Vital status at D28 in Dexamethasone arms vs Prednisolone arms;Timepoint(s) of evaluation of this end point: 28 days after the randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Respiratory symptoms will be defined by the measurement of oxygen saturation associated with oxygen flow and respiratory rate once a day during 14 days then three times a week until D28<br>Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale)<br>Measurement of patient quality of life evolution with EQ5D self-assessment questionnaire<br>Proportion of adverse events and adverse effects during the 28 days of the study;Timepoint(s) of evaluation of this end point: At D28