COVID19
Conditions
Interventions
Trade Name: Sylvant
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Siltuximab
CAS Number: 541502-14-1
Concentration unit: mg/kg milligram(s)/kilogram
Concen
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old. 2. Hospitalized patient (or documentation of a hospitalization plan if the patient is in an emergency department) with illness of more than 5 days of duration with evidence of pneumonia by chest radiography / tomography computed chest and meets at least one of the following requirements: a) Non-critical patient with pneumonia in radiological progression and / or b) Patient with progressive respiratory failure at the last 24-48 hours. 3. Laboratory confirmed SARS-CoV-2 infection (by PCR) or other commercialized analysis or public health in any sample collected 4 days before the randomization or COVID-19 criteria following the defined diagnostic criteria at that time in the center. 4. Patient with a maximum O2 support of 35% 5. Be willing and able to comply with the study related procedures / evaluations. 6. Women of childbearing potential * should have a negative serum pregnancy test before enrollment in the study and must commit to using methods highly effective contraceptives (intrauterine device, bilateral tubal occlusion, vasectomized couple and sexual abstinence). 7. Written informed consent. In case of inability of the patient to sign the informed consent, a verbal informed consent from the legal representative or family witness (or failing this, an impartial witness outside the investigator team) will be obtained by phone. When circumstances so allow, participants should sign the consent form. The confirmation of the verbal informed consent will be documented in a document as evidence that verbal consent has been obtained. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Patient who, in the investigator's opinion, is unlikely to survive> 48 hours after the inclusion in the study. 2. Presence of any of the following abnormal analytical values at the time of the inclusion in the study: - absolute neutrophil count (RAN) less than 2000 / mm3; - AST or ALT> 5 times the ULN; - platelets <50,000 per mm3. 3. In active treatment with immunosuppressants or previous prolonged treatment (more 3 months) of oral corticosteroids for a disease not related to COVID-19 at a dose greater than 10 mg of prednisone or equivalent per day. 4. Known active tuberculosis (TB) or known history of TB uncompleted treatment. 5. Patients with active systemic bacterial and / or fungal infections. 6. Participants who, at the investigator's discretion, are not eligible to participate, regardless of the reason, including medical or clinical conditions, or participants potentially at risk of not following study procedures. 7. Patients who do not have entry criteria in the Intensive Care Unit. 8. Pregnancy or lactation. 9. Known hypersensitivity to siltuximab or to any of its excipients (histidine, histidine hydrochloride, polysorbate 80 and sucrose).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of siltuximab vs corticosteroids in hospitalized patients with COVID19 pneumonia by evaluating the number of admissions in the unit intensive care (ICU);Secondary Objective: -Stay in the ICU -Time to resolution of fever for at least 48 hours, without administration of antipyretics -Incidence of worsening in the oxygen therapy requirement -Duration of supplemental oxygen dependence -Incidence of the use of mechanical ventilation -Duration of the use of mechanical ventilation -Time to start of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula -Days of hospitalization -Mortality rate at 29 days -Incidence of SAEs -Incidence of invasive bacterial or fungal infections or opportunistic with grade 4 neutropenia -Incidence of invasive bacterial or fungal infections or opportunistic -Incidence of hypersensitivity reactions or reactions grade 2 related to the infusion -Incidence of GI perforations -Incidence of new serious secondary infections or worsening of existing infections -Changes in leukocytes, Hb, platelets, creatinine, bilirubin, ALT -Changes in inflammatory biomarkers -Changes in chest X-ray;Primary end point(s): Proportion of patients requiring ICU admission at any time within the study period.;Timepoint(s) of evaluation of this end point: 29 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Days of stay in the ICU during the study period. 2. Days until resolution of fever defined as body temperature (axillary = 36.6 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge, whichever occurs first 3. Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. 4. Days until improvement in oxygenation (SpO2 / FiO2 increase of 50 or more in comparison with SpO2 / FiO2 nadir) for at least 48 hours, depending on clinical severity at 29 days. 5. Days with hypoxemia (SpO2 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9. 24. Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9. 25. Changes from baseline in chest Rx at days 1, 3 and 5.;Timepoint(s) of evaluation of this end point: 29 days | — |
Countries
Spain
Contacts
Public ContactFelipe García
Hospital Clínic
Outcome results
None listed