PHASE III RANDOMIZED, UNICENTRIC OPEN, CONTROLLED CLINICAL TRIAL TO DEMONSTRATE THE EFFECTIVENESS OF TOCILIZUMAB AGAINST SYSTEMIC CORTICOTHERAPY IN PATIENTS ENTERED BY COVID-19 WITH BILATERAL PNEUMONIA AND BAD EVOLUTIO
- Conditions
- bilateral SARS-CoV-2 pneumonia with poor clinical courseTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001707-16-ES
- Lead Sponsor
- IIS BIODONOSTIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method