Randomized, Unicentric, Open, Controlled Clinical Trial,... | NCT05002517

NCT05002517

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tociliziumab group	Experimental	Patients assigned to this arm will receive an intravenous dose of tocilizumab. Patients weighing 75 kg or more will receive 600 mg. Those weighing less than 75 kg will receive 400 mg.	Drug: Tociliziumab group
Metilprednisolone group	Active Comparator	Patients in this arm will receive a daily intravenous dose of 250 mg methylprednisolone for 3 days.	Drug: Methylprednisolone group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tociliziumab group	Drug	Tocilizumab is a humanized recombinant IgG1 monoclonal antibody to human interleukin-6 (IL-6) receptor, produced in Chinese hamster ovary cells by recombinant DNA technology.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory situation at 24 hours, 3 and 7 days based on the PaO2 / FiO2 ratio that graduates respiratory distress into mild (200-300), moderate (100-200) and severe (<100).	Quantitative variable that will be analyzed as qualitative (better, worse) based on whether there is a change in the graduation described above.	7 days
Immune hyperactivation situation: LDH, D-dimer and ferritin value 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 2 of the 3 variables will be considered "worse"; "Better" if there is improvement in 2 of the 3.	7 days
Mechanical ventilation: qualitative variable (yes or no)		7 days
Combined variable of variables i, iii and in-hospital mortality (this is understood to be: respiratory deterioration or need for mechanical ventilation or in-hospital death)		7 days

Secondary Outcomes

Measure	Description	Time Frame
Number of patients admitted to the ICU		10 months
Time to admission to the ICU (from the beginning of the trial and from the beginning of the picture)		10 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) Patient over 18 years old
2) Ability to grant consent
3) Bilateral pneumonia produced by SARS-CoV-2 without response in 48-72 hours after starting the treatment used according to the local protocol. This is defined as persistence of fever (above 37.5ºC without another focus) and respiratory worsening (more dyspnea and / or more cough and / or oxygen therapy at increasing doses and / or worsening of the degree of respiratory distress according to the PaO2 / FiO2 ratio in categories "mild, moderate or severe") or absence of improvement compared to the previous state
4) Persistently elevated inflammatory markers, among which the following 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], and / or CRP above 150 (mg / L) or having doubled the CRP provided it was above 50. Since this is what is included within the definition of "inflammatory phenotype"

Exclusion Criteria:

1) Embarazo y lactancia
2) Situación terminal o esperanza de vida inferior a 30 días a juicio del investigador
3) Alergia o intolerancia a alguno de los fármacos en estudio o a alguno de los excipientes de los preparados (p. ej polisorbato 80)
4) Interacción no tolerable de los fármacos del estudio con alguna medicación crónica imprescindible del paciente
5) Transaminasas elevadas por encima de cinco veces el límite superior de la normalidad
6) Severe neutropenia (<500 cells / mm3)
7) Plaquetopenia <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 mmHg, with a lactate of more 2 mmol / L, despite adequate volume replacement
9) Another active infection at any level
10) Complicated diverticulitis or intestinal perforation
11) Renal failure with estimated glomerular filtration rate less than 30 mL / min
12) Hepatic failure (Child B onwards)
13) Previous use (during the acute process or as chronic medication for another reason) of medication with a potential effect in this phase of the disease (janus kinase inhibitors, interleukin 1 inhibitors, other immunosuppressants or immunomodulators that in the opinion of the investigator could have an effect on the disease based on pathophysiological criteria or on previous research or started in this same period). Clarification: The use of dexamethasone according to the RECOVERY study guideline or corticosteroid therapy at equivalent doses will not be included at this point.
14) Being 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