SARS-CoV-2 infection (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Urbason/Metilprednisolona
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 83-43-2
Current Sponsor code: -
Other descr
Sponsors
IDIVAL Instituto de Investigación Sanitaria Valdecilla
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients admitted to hospital with Covid-19, confirmed by microbiological tests or compatible clinical manifestations, with exclusion of other infections. - Age: 18-85 years old. - Time of evolution: more than 7 days since the beginning of symptoms. - Evidence of inflammation, defined by: Lung infiltrates + Gas exchange disturbance: PaO2 15, or DD>800, or Ferritin >1000, or IL6>20 - Absence of bacterial infection or other disease that explains the lung disorder. - Verbal informed consent, which will be recorded in history. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: - Refusal to participate - Pregnancy - Established indication for mechanical ventilation, non-invasive ventilation or ICU admission - Immunosuppression - Chronic renal failure on dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of early anti-inflammatory treatment with corticosteroids in patients who are in a phase of the disease in which viral replication has already been limited, but there is a marked systemic inflammatory response.;Secondary Objective: To evaluate the safety of early anti-inflammatory treatment with corticosteroids;Primary end point(s): Combination of death, ICU stay or non-invasive ventilation (NIV).;Timepoint(s) of evaluation of this end point: At the time of discharge or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Individual components of the primary variable. - Clinical-gasometric impairment after the test intervention (defined as: (a) PaO2/FIO2<250; or (b) shock); or (c) worsening of qSOFA or BCRSS indices). - Change in SOFA score (comparison at time of inclusion and at 4 days). - Length of hospital stay. - Use of biological anti-inflammatories.;Timepoint(s) of evaluation of this end point: At the time of discharge or death | — |
Countries
Spain
Contacts
Public ContactMar García Sáiz
IDIVAL
Outcome results
None listed