Severe COVID-19 pneumonia MedDRA version: 21.1 Level: PT Classification code 10035737 Term: Pneumonia viral System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Sandimmun
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration t
Sponsors
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years 2. Severe COVID-19 pneumonia definied as: - Nasnopharyngeal smear SARS-CoV-2 PCR positive - Pulmonary infiltrates by simple X-ray (or other technique) compatible with pneumonia - One or more of the following criteria: o Room air oxygen saturation =65 years) yes F.1.3.1 Number of subjects for this age range 145
Exclusion criteria
Exclusion criteria: 1. GOT/GPT > 5 the institutional ULN 2. Neutrophils < 500 cell/mmc. 3. Petelet < 50.000 cell/mmc. 4. Documented sepsis o pneumonia different from COVID-19. 5. According to clinician criteria, comorbilities with poor prognosis 6. Compliate Diverticulitis or bowel perforation 7. Current skin infection (p.e piodermitis) 8. According to the clinician criteria, any contraindication for using inmunomodulator tretament.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the mortality impact at 28 days of an immunomodulatory strategy with 2 treatment regimens stratified according to IL-6 plasma levels, administered in addition to standard treatment, in adult patients with severe COVID-19 pneumonia.;Secondary Objective: To assess the impact of this strategy on the following variables: premature mortality (48 hours, 7 days and at hospital), mortality at intensive care unit, days of mechanical ventilation, virus clearance (viral clearance / viral shedding), time to normalization of oxygen saturation , time to defervescence, improvement of inflammatory reaction, days of hospitalization, days of intubation, safety and tolerability of the intervention;Primary end point(s): Mortality at day 28 after treatment initiation (proportion of patient died that day);Timepoint(s) of evaluation of this end point: Day 28 after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mortality at 48 hours, 7 days, at Intensive Care Unit and at hospital - Days with mechanical ventilation, days at Intensive Care Unit and days at hospital - Viral clearance (viral clearance / viral shedding) - Time until normal Oxygen saturation - Time until defervescence - Inflamatory reaction improvement (IL1b, IL12, IL2, TNF?, IFN?, IL2Rs, IL6, Il10, ferritine, D-dimer, triglycerides, lymphopenia, protein C reactive, VSG) - Frequency and severity of adverse events according to common scales, proportion of patients drop-out due adverse events. Secondary infections. - Plasmatic parameters, direct or indirect: IL1b, IL12, IL2, TNF?, IFN?, IL2Rs, IL6, Il10, ferritine, D-dimer, triglycerides, lymphopenia, protein C reactive, VSG) - Clinic Oxygenation parameters (PaO2, pulse oximetry). - Viral Clearance (viral clearance / viral shedding): PCR SARS-CoV-2 control. - Standard Intensive Care Unit parameters: SOFA and APACHE II at hospitalisation, intubation day, mechanical ventilation withdrawal day, Intensive Care Unit discharge, Hospital discharge.;Timepoint(s) of evaluation of this end point: 48 hours 7 days Stay days Mechanical ventilation days | — |
Countries
Spain
Contacts
Public ContactSalvador Augustin
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Outcome results
None listed