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

Efficacy and Safety of corticoids in patients with adult respiratory distress syndrome (ARDS) secondary to COVID-19. - Steroids In Coronavirus (SIC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001307-16-ES

Enrollment

104

Registered

2020-04-08

Start date

2020-04-01

Completion date

Unknown

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult respiratory distress syndrome (ARDS) secondary to SARS-CoV-2

Interventions

Trade Name: Solu-Moderín 1 g polvo y disolvente para solución inyectable Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: Metilprednisolona (como succin

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 65

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

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

Measure

Time frame

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

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Countries

Spain

Contacts

Public ContactAnabel Sánchez

Fundación para la Investigación Biomédica Hospital Ramón y Cajal

anabelsanchez.hrc@gmail.com+34913368825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026