CoVid-19 pneumonia in early inflammatory phase (stage II).
Conditions
Interventions
Trade Name: Methylprednisolone
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 2375-03-3
Other descriptive name: METHYLPREDNISOLO
Sponsors
NAVARRABIOMED - FUNDACIÓN MIGUEL SERVET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years. • Diagnosis of SARS-CoV-2 pneumonia by reverse transcriptase polymerase chain reaction (RT-PCR) in nasopharyngeal or sputum smears according to the recommendations of the Ministry of Health. • Duration of symptoms = 7 days. • At least one of the following: C-reactive protein (PCR)> 60 mg / L or interleukin 6 (IL-6)> 40 pg / mL or ferritin> 1000 µg / L. • Acceptance of informed consent. 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: • Allergy or contraindication to the drugs under study. • Respiratory failure data: SpO2 0.5 ng / mL) of active infection other than SARS-CoV-2. • Out-of-hospital management patient. • Conservative or palliative management patient. • Participation in another clinical trial. • Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of glucocorticoid boluses in the inflammatory phase of SARS-CoV-2 pneumonia.;Secondary Objective: • Compare mortality at 28 days. • Compare the proportion of ICU admissions at 28 days. • Compare the ratio need for rescue treatment with tocilizumab at 14 days. • Compare the days of hospital admission. • Compare the evolution of the analytical parameters of inflammation: C-reactive protein (PCR), interleukin 6 (IL-6), ferritin, D-dimer (DD). • Compare the proportion of serious adverse events. • Compare the proportion of bacterial, fungal, or opportunistic infections. • Compare the clearance of the virus detected by nasopharyngeal PCR.;Primary end point(s): Proportion of patients with treatment failure up to 14 days after randomization. Definition of treatment failure: to. Death of the patient, or b. ICU admission, or c. Start of mechanical ventilation, or d. Clinical deterioration / worsening, defined as decrease in SpO2 below 90% or PaO2 below 60 mmHg in ambient air + radiological progression.;Timepoint(s) of evaluation of this end point: 14 DAYS OF HOSPITALISATION | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mortality 28 days after randomization. • Proportion of ICU admissions 28 days after randomization. • Proportion of rescue treatment with tocilizumab or with methylprednisolone + tocilizumab 14 days after randomization. • Days of hospital stay. • Proportion of serious adverse events. • Proportion of bacterial, fungal or opportunistic infections. • Differences in the analytical parameters indicative of inflammation (PCR, IL-6, ferritin, D-dimer) 14 days after randomization. • Clearance of the virus detected by nasopharyngeal RT-PCR at 7 days.;Timepoint(s) of evaluation of this end point: 28 DAYS OF HOSPITALISATION | — |
Countries
Spain
Contacts
Public ContactCLINICAL TRIAL UNIT
NAVARRABIOMED - FUNDACIÓN MIGUEL SERVET
Outcome results
None listed