Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab

Asociacion Instituto Biodonostia

Status and phase: Unknown; Phase 3

Conditions: COVID-19 Pneumonia

Treatments: Drug: Tociliziumab group; Drug: Methylprednisolone group

Study type: Interventional

Funder types: Other

Identifiers

NCT05002517

TOCICOVID

Details and patient eligibility

About

Randomized, open, single-center, controlled clinical trial, with 2 treatment arms that seeks to demonstrate the effectiveness of tocilizumab against systemic corticosteroids, both treatments added to supportive treatment in patients admitted for COVID-19 with bilateral pneumonia and poor evolution

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Tociliziumab group

Experimental group

Description:

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.

Treatment:

Drug: Tociliziumab group

Metilprednisolone group

Active Comparator group

Description:

Patients in this arm will receive a daily intravenous dose of 250 mg methylprednisolone for 3 days.

Treatment:

Drug: Methylprednisolone group