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.
Conditions
Interventions
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
Sponsors
Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Unive
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Unconfirmed SARS-CoV-2 infection Pregnant or breastfeeding women Oral or inhaled corticosteroid therapy within 15 days before Oral or inhaled corticosteroid therapy for chronic medical condition Immunosuppressive therapy Cytotoxic chemotherapy within 30 days before Neutrophil count < 1000 cells/mm3 for hematologic malignancy or solid tumor Dementia or psychosis Human immunodeficiency virus infection Patients with liver disease defined as ALT or AST = 5 times the upper limit of normal Patients with kidney disease defined as glomerular filtration rate = 30 ml/min, hemodialysis or peritoneal dialysis Uncontrolled bacterial infection Drug use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to prevent the moderate-severe acute respiratory distress syndrom;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;Primary end point(s): The Primary end point of this trial is do not require supplementary oxigen during hospitalization;Timepoint(s) of evaluation of this end point: One week | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactÁngel Pueyo
Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor
Outcome results
None listed