DEXamethasone EARLY administration in hospitalized patients with Covid-19 pneumonia and high risk of developing acute respiratory distress syndrome

INTERVENTION: Trade Name: dexamethasone Product Name: DEXAMETHASONE Product Code: DEXAMETHASONE Pharmaceutical Form: Solution for infusion INN or Proposed INN: DEXAMETHASONE CAS Number: 50‐02‐2 Current Sponsor code: SUB07017MIG Concentration unit: Bq/mg becquerel(s)/milligram Concentration type: equal Concentration number: 6‐ CONDITION: Hospitalized patients with Covid‐19 pneumonia who do not require oxygen therapy on admission associated with at least two of the three following factors related with severe Covid‐19: lactate dehydrogenase > 245 U/L, C‐reactive protein > 100 mg/L and lymphocyte count < 800 cells/µL. Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: The main objective of the trial is to prevent the moderate‐severe acute respiratory distress syndrom Primary end point(s): The Primary end point of this trial is do not require supplementary oxigen during hospitalization Secondary Objective: ‐ All‐cause mortality within 28 days after randomization; ‐ Admission to the Intensive Care Unit or Intermediate Care Unit within 28 days after randomization; ‐ Clinical status of the patient using the World Health Organization ordinal scale; ‐ Clinical status of the patient using Sequential Organ Failure Assessme Score; ‐ Hospital stay; ‐ Respiratory support at hospital discharge; ‐ All‐cause readmission within 3 months after randomization Timepoint(s) of evaluation of this end point: One week SECONDARY OUTCOME: Secondary end point(s): Mortality, admission to the Intensive Care Unit or Intermediate Care Unit, World Health Organization ordinal scale, Sequential Organ Failure Assessme Score, hospital stay and readmission Timepoint(s) of evaluation of this end point: Three months INCLUSION CRITERIA: Hospitalized patients with Covid‐19 pneumonia who do not require oxygen therapy on admission associated with at least two of the three following factors related with severe Covid‐19: lactate dehydrogenase > 245 U/L, C‐reactive protein > 100 mg/L and lymphocyte count < 800 cells/µL. 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 76 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50