DEXamethasone EARLY administration in hospitalized patients with Covid-19 pneumonia

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2021-001028-16-ES
• Lead Sponsor: Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Unive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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<br>- Admission to the Intensive Care Unit or Intermediate Care Unit within 28 days after randomization<br>- Clinical status of the patient using the World Health Organization ordinal scale<br>- Clinical status of the patient using Sequential Organ Failure Assessme Score<br>- Hospital stay<br>- Respiratory support at hospital discharge<br>- 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 Outcome Measures

Name	Time	Method
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