Efficacy of dexamethasone for treatment of patients affected by COVID-19 with Acute Respiratory Distress Syndrome

Phase 1

• Conditions: Acute respiratory distress syndrome (ARDS) in patients affected by COVID-19; MedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001278-31-ES
• Lead Sponsor: Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-01
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

To be eligible for inclusion into this study (Day 0), each patient must fulfil the following inclusion criteria during screening and prior to the enrolment into the study:

a.Age >=18 years old
b.Patients must have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS:
i.Having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.).
ii.bilateral infiltrates on frontal chest radiograph
iii.absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure
iv.severe hypoxemia (a PaO2/FIO2 <=200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)
c.Be intubated and mechanically ventilated
d. to have a positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for COVID-19 in a respiratory tract sample;
e.Have provided signed written informed consent from the patient or the patient's personal legal representative.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

o be eligible for inclusion into this study (Day 0), each patient must not have any of the following exclusion criteria during screening and prior to the enrolment into the study:

a.Be a woman known to be pregnant or lactating
b. Patients with a known contraindication to corticosteroids,
c. A decision by a physician that involvement in the trial is not in the patient’s best interest,

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of dexamethasone in reducing overall mortality.;Secondary Objective: -To evaluate the efficacy of dexamethasone in increasing by the number of ventilator-free days days (VFDs) at 28 days.;Primary end point(s): All-cause hospital mortality;Timepoint(s) of evaluation of this end point: At hospital discharge

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Number of ventilator free-days (VFDs) at Day 28 (defined as days alive and free from mechanical ventilation at day 28 after intubation. For subjects ventilated >=28 days and for subjects who die, VFD is 0.<br>-Mortality at ICU and at Day 28<br>-Duration (in days) on mechanical ventilation<br>-Length of stay (in days) in the hospital for survivors<br>-Time (in days) from treatment initiation to death<br>-Proportions with viral RNA detection over time.;Timepoint(s) of evaluation of this end point: At hospital discharge