Efficacy of the early use of corticotherapy in CoV-2 infection to prevent the progression of acute respiratory distress syndrome (ARDS)

Efficacy of the early use of corticotherapy in CoV-2 infection to prevent the progression of acute respiratory distress syndrome (ARDS) in COVID-19

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002186-34-ES

Enrollment

100

Registered

2020-07-22

Start date

2020-06-03

Completion date

Unknown

Last updated

2021-09-13

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

Conditions

COVID-19 Pneunomia (SARS-CoV-2) MedDRA version: 23.0 Level: PT Classification code 10084380 Term: COVID-19 pneumonia System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Solu-Moderín Product Name: Solu-Moderín Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: Solu-Moderín Other descriptive name: METHYLPREDNISOLONE Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 - 80 2. Coronavirus-19 infection (SARS-CoV-2) demonstrated by nasopharyngeal smears PCR or any other biological sample 3. COVID-19 described as: - Nasopharyngeal smear with SARS-CoV-2 positive PCR - Lung infiltrates by radiography (or other imaging technique) consistent with pneumonia - Puntuation of 3 or 4 in the WHO Ordinal Scale for Clinical Improvement for COVID-19 - One of the following criteria: a) Ambient air oxygen saturation> 90 and 200 and =300 mmHg c) Sa: FiO2 (O2 saturation measured with pulse oximeter / inspired O2 fraction) =350 - All patients will receive standard treatment according to site guidelines (eg hydroxychloroquine), as long as there is no contraindication for it. 5. Informed consent (according to protocol instructions) 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. Previous treatment with oral or intravenous corticosteroids for more than 5 days in a row or alternate days (6 previous months) 2. Treatment during the previous 12 months with biological drugs such as monoclonal antibodies including anti-TNFa, anti-interleukins, Interferons type I. 3. Any other contraindication for the use of individualized corticosteroid pulses according to the clinical criteria of the patient medical team. 4. Contraindications to treatment with methylprednisolone (limited to known hypersensitivity to the active substance and its excipients), as well as receiving treatment in a post-vaccination period (with live or live attenuated microorganism vaccines). 5. Patients with severe SDRA, defined as SaFi < 150. 6. Patients with chronic obstructive pulmonary disease requiring home oxygen.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the impact of the administration of early corticosteroid on the evolution of ARDSpulses in patients with coronavirus-19 pneumonia (SARS-CoV-2) that causes mild respiratory distress. This impact will be assessed by means of a combined variable made up of the variables death, ICU admission, non-invasive mechanical ventilation or need for high-flow oxygen therapy (defined as SaFi <200 with FiO2 = 50%).;Secondary Objective: - Mortality at hospital, day 28, day 60 and day 90. - Need for non-invasive mechanical ventilation, high-flow or invasive cannulas and duration thereof - Time to normalization of oxygen saturation - Days of hospitalization - Days to clinical improvement (reduction of 2 points in the WHO Ordinal Scale for Clinical Improvement) - Safety and tolerability of the intervention - Opportunistic and secundary infections - Need of tocilizumab or other biological or immunomodulatory treatment second line during hospitalization;Primary end point(s): Incidence of a combined variable made up of the variables death, ICU admission, non-invasive mechanical ventilation or need for high-flow oxygen therapy (defined as SaFi <200 with FiO2 = 50%).;Timepoint(s) of evaluation of this end point: Day 90	—

Measure

Time frame

Main Objective: To assess the impact of the administration of early corticosteroid on the evolution of ARDSpulses in patients with coronavirus-19 pneumonia (SARS-CoV-2) that causes mild respiratory distress. This impact will be assessed by means of a combined variable made up of the variables death, ICU admission, non-invasive mechanical ventilation or need for high-flow oxygen therapy (defined as SaFi <200 with FiO2 = 50%).;Secondary Objective: - Mortality at hospital, day 28, day 60 and day 90. - Need for non-invasive mechanical ventilation, high-flow or invasive cannulas and duration thereof - Time to normalization of oxygen saturation - Days of hospitalization - Days to clinical improvement (reduction of 2 points in the WHO Ordinal Scale for Clinical Improvement) - Safety and tolerability of the intervention - Opportunistic and secundary infections - Need of tocilizumab or other biological or immunomodulatory treatment second line during hospitalization;Primary end point(s): Incidence of a combined variable made up of the variables death, ICU admission, non-invasive mechanical ventilation or need for high-flow oxygen therapy (defined as SaFi <200 with FiO2 = 50%).;Timepoint(s) of evaluation of this end point: Day 90

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Secondary

Measure	Time frame
Secondary end point(s): - Mortality at hospital, day 28, day 60 and day 90. - Need for non-invasive mechanical ventilation, high-flow or invasive cannulas and duration thereof (days) - Time to normalization of oxygen saturation - Days of hospitalization - Days to clinical improvement (reduction of 2 points in the WHO Ordinal Scale for Clinical Improvement) - Safety and tolerability of the intervention - Opportunistic and secundary infections - Need of tocilizumab or other biological or immunomodulatory treatment second line during hospitalization;Timepoint(s) of evaluation of this end point: Day 28, day 60 and Day 90	—

Measure

Time frame

Secondary end point(s): - Mortality at hospital, day 28, day 60 and day 90. - Need for non-invasive mechanical ventilation, high-flow or invasive cannulas and duration thereof (days) - Time to normalization of oxygen saturation - Days of hospitalization - Days to clinical improvement (reduction of 2 points in the WHO Ordinal Scale for Clinical Improvement) - Safety and tolerability of the intervention - Opportunistic and secundary infections - Need of tocilizumab or other biological or immunomodulatory treatment second line during hospitalization;Timepoint(s) of evaluation of this end point: Day 28, day 60 and Day 90

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Countries

Spain

Contacts

Public ContactFerran Martínez Valle

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR).

34934893000

Outcome results

None listed

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