Efficacy and Safety of corticoids in patients with adult respiratory distress syndrome (ARDS) secondary to coronavirus infection.

Phase 1

• Conditions: Adult respiratory distress syndrome (ARDS) secondary to SARS-CoV-2; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001307-16-ES
• Lead Sponsor: Fundación para la Investigación Biomédica Hospital Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-08
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Diagnosis of SARS-CoV-2 by testing the polymerase chain reaction performed on a respiratory sample;
2. Pneumonia confirmed by radiological imaging test;
3. ARDS Criteria:
(i) bilateral infiltrates;
(ii) PO2/FiO2 <300 mmHg; And
(iii) reasonable clinical exclusion of heart cause (requires all).
4. Verbal consent of the patient.
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 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. Age <18 years;
2. Less than 5 days from the onset of symptoms to randomization;
3. Pregnancy;
4. Hypersensitivity or known allergy to methylprednisolone;
5. Bacterial infection: not drained abscess, intravascular infection, bacterial pneumonia, septic shock, disseminated fungal infection;
6. Participation in another trial in the previous 30 days;
7. Acquired immunodeficiency syndrome;
8. Previous use of corticosteroids (cumulative dose of prednisone [or equivalent] of more than 300 mg in the last 21 days; or more than 15 mg/day in the last 7 days before randomization);
9. Cytotoxic treatment in the last 3 weeks;
10. Known or suspected adrenal insufficiency;
11. Lung or bone marrow transplant;
12. Severe liver disease.

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 methylprednisolone treatment, added to the standard treatment, in patients with ARDS secondary tp SARS-CoV-2 .;Secondary Objective: To evaluate the safety of methylprednisolone treatment, added to the standard treatment, in patients with ARDS secondary to SARS-CoV-2.;Primary end point(s): The primary end point of efficacy will be death for any cause in the first 28 days after randomization.;Timepoint(s) of evaluation of this end point: The first 28 days after randomization.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary end points of efficacy will be:<br>• Mortality from any cause on days 7 and 14 after randomization.<br>• Days without mechanical ventilation (invasive or non-invasive) within the first 28 days after randomization.<br>• Duration of hospitalization (in survivors).<br><br>The secondary end points of safety will be:<br>• Adverse reactions in the first 28 days after randomization.;Timepoint(s) of evaluation of this end point: In the first 28 days after randomization. <br>On 7 and 14 days after randomization ( mortality for any cause)