In our center up to 25% of the hospitalized patients with COVID-19 progress and need an intensive care unit. It is urgent to find measures that can avoid this progression to severe stages of the disease. We hypothesize that the use of anti-inflammatory drugs used at the time they start hyperinflammation episodes could improve symptoms and prognosis of patients and prevent their progression sufficiently to avoid their need for be admitted to an Intensive Care Unit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
163
A single-dose of 11mg/Kg of siltuximab will be administered by intravenous infusion.
A dose of 6mg/24 hours of dexamethasone during 10 days will be administered orally or by intravenous infusion.
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Spain
Proportion of patients requiring ICU admission at any time within the study period.
Time frame: 29 days
Days of stay in the ICU during the study period.
Time frame: 29 days
Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C, oral ≤ 37.2 ° C, or rectal or tympanic ≤ 37.8 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge.
Time frame: 29 days
Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days.
Time frame: 29 days
Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days.
Time frame: 29 days
Proportion of patients using mechanical ventilation at 29 days.
Time frame: 29 days
Days with use of mechanical ventilation at 29 days.
Time frame: 29 days
Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days.
Time frame: 29 days
Days of hospitalization among survivors at 29 days.
Time frame: 29 days
Mortality rate from any cause at 29 days.
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Time frame: 29 days
Proportion of patients with serious adverse events at 29 days.
Time frame: 29 days
Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute <500 / mm3) at 29 days.
Time frame: 29 days
Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days.
Time frame: 29 days
Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days.
Time frame: 29 days
Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days.
Time frame: 29 days
Proportion of patients with gastrointestinal perforation at 29 days.
Time frame: 29 days
Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days.
Time frame: 29 days
Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9.
Time frame: Days 1, 3, 5, 7 and 9
Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9.
Time frame: Days 1, 3, 5, 7 and 9
Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9.
Time frame: Days 1, 3, 5, 7 and 9
Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9.
Time frame: Days 1, 3, 5, 7 and 9
Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9.
Time frame: Days 1, 3, 5, 7 and 9
Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 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.
Time frame: Days 1, 3, 5, 7 and 9
Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9.
Time frame: Days 1, 3, 5, 7 and 9
Changes from baseline in chest Rx at days 1, 3 and 5.
Time frame: Days 1, 3 and 5
Analysis of genetic variants in CYP enzymes and transporters SLCO1B1, ABCCs and ABCB1 to the response to the study treatments.
Time frame: 29 days