bilateral SARS-CoV-2 pneumonia with poor clinical course
Conditions
Sponsors
IIS BIODONOSTIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient over 18 years old 2) Ability to grant consent 3) Bilateral pneumonia caused by SARS-CoV-2 without response to the treatment used according to local protocol. This is defined as persistence of fever (above 37.5ºC without other focus) and respiratory worsening (more dyspnea, more cough, oxygen therapy at increasing doses, worsening of the degree of respiratory distress according to the PaO2 / FiO2 ratio in categories “mild, moderate or serious ") or absence of improvement with respect to the previous state 4) Persistently elevated inflammatory markers, among which must be met: ferritin greater than 1000 ng / mL and / or D-dimer greater than 1500 ng / mL and / or IL-6 greater than 40 pg / mL [35-37]. 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 60
Exclusion criteria
Exclusion criteria: 1) Pregnancy and lactation 2) Terminal situation or life expectancy less than 30 days in the judgment of the researcher 3) Allergy or intolerance to any of the drugs under study or to any of the excipients of the preparations (eg polysorbate 80) 4) Non-tolerable interaction of the study drugs with some essential chronic medication of the patient 5) Transaminases raised above five times the upper limit of normal 6) Severe neutropenia (<500 cells / mm3) 7) Plateletpenia <50,000 / mm3 8) Sepsis (clinical suspicion of active infection at another level with a value on the qSOFA scale of two or more points) or septic shock (need for vasopressors to maintain a mean arterial pressure greater than or equal to 65 10 mmHg, with a lactate greater than 2 mmol / L, despite adequate volume replacement 9) Another active infection at any level 10) Complicated diverticulitis or intestinal perforation 11) Kidney failure with estimated glomerular filtration less than 30 mL / min 12) Liver failure (Child B onwards) 13) Previous use (during the acute process or as chronic medication for another reason) of medication with potential effect in this phase of the disease (Janus kinase inhibitors, interleukin-1 inhibitors, other immunosuppressants or immunomodulators that, in the investigator's judgment) could have an effect on the disease based on pathophysiological criteria or previous research or started up in this same period) 14) Be included in another clinical trial 15) Patients who, due to their current situation, their baseline situation or other aspects, in the opinion of the researcher, are not considered candidates to enter the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of tocilizumab over corticosteroids with respect to the improvement of the respiratory situation and hyperactivation of the immune system;Secondary Objective: i. Evaluate the time until admission to the ICU ii. Assess the time until intubation iii. Assess the length of ICU admission iv. Assess the total length of admission v. Assess in-hospital mortality saw. Assess mortality in the medium term (30 and 60 days) vii. Assess the respiratory situation in the medium term (30 and 60 days) viii. Assess intracurrent intercurrent infections;Primary end point(s): Respiratory situation at 24 hours, 3 and 7 days based on PaO2 / FiO2 ratio that graduates respiratory distress from mild (200-300), moderate (100-200) and severe (<100). In addition, it will include: presence of dyspnea and grade according to the New York Health Association (NYHA) scale, presence of respiratory work and respiratory rate (FR). ii. PCR value, LDH, D-dimer, ferritin, IL-6 and total lymphocytes at 24 hours, 3 and 7 days. Each one is a quantitative variable. They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 3 of the 5 variables will be considered “worse”; “Better” if there is improvement in 3 out of 5. iii. Mechanical ventilation: qualitative variable (yes or no) iv. Combined variable of variables i and / or iii and / or in-hospital mortality;Timepoint(s) of evaluation of this end point: Quantitative variable that will be analyzed as qualitative (better, worse) based on whether there is a change in the previously described graduation. - Each one is a quantitative variable. They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 2 of the 3 variables will be considered “worse”; “Better” if there is improvement in 2 of the 3. - qualitative variable (yes or no) - respiratory worsening or need for mechanical ventilation or in-hospital death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i Number of patients admitted to the ICU ii. Time to ICU admission (from the start of the trial and from the start of the symptoms) iii. Time to start of mechanical ventilation (from the start of the trial and from the start of the symptoms) iv. ICU admission time v. Total entry time saw. In-hospital mortality vii. Mortality at 30 and 60 days viii. Respiratory situation at 30 and 60 days according to pulse oximetric O2 saturation, respiratory rate and presence of dyspnea and NYHA grade ix. Documented in-hospital infections;Timepoint(s) of evaluation of this end point: i Number of patients admitted to the ICU ii. Time to ICU admission (from the start of the trial and from the start of the symptoms) iii. Time to start of mechanical ventilation (from the start of the trial and from the start of the symptoms) iv. ICU admission time v. Total entry time saw. In-hospital mortality vii. Mortality at 30 and 60 days viii. Respiratory situation at 30 and 60 days according to pulse oximetric O2 saturation, respiratory rate and presence of dyspnea and NYHA grade ix. Documented in-hospital infections | — |
Countries
Spain
Contacts
Public ContactIIS BIODONOSTIA
IIS BIODONOSTIA
Outcome results
None listed