Care of severe forms of CoViD-19 from the transitional phase and the onset of the inflammatory phase with corticosteroids MedDRA version: 23.0 Level: LLT Classification code 10084270 Term: SARS-CoV-2 acute respiratory disease System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: PT Classification code 10084268 Term:
Conditions
Interventions
Trade Name: Prednisolone
Product Name: Solupred
Pharmaceutical Form: Orodispersible tablet
Trade Name: Dexamethasone
Product Name: Dectancyl
Pharmaceutical Form: Orodispersible tablet
Sponsors
Hospital Center rené Dubos
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 ….)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mortality assessment at D28;Secondary Objective: Evolution of respiratory symptoms in both groups Assessment of patient satisfaction towards the treatment Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups ;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
| Measure | Time frame |
|---|---|
| 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 Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale) Measurement of patient quality of life evolution with EQ5D self-assessment questionnaire Proportion of adverse events and adverse effects during the 28 days of the study;Timepoint(s) of evaluation of this end point: At D28 | — |
Countries
France
Contacts
Public ContactClinical Research Unit
Hospital Center René Dubos
Outcome results
None listed