The COVID-19 infection primarily manifests itself as a respiratory tract infection, although new evidence indicates that this disease has systemic involvement involving multiple systems including the cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune systems. Recent studies have shown that in its pathophysiology, inflammation and thrombogenesis predominate, especially in the severe forms of COVID-19. Thus, the investigators hypothesized that the use of heparin and tocilizumab could potencially reduce inflammation and thrombogenesis in patients with severe COVID-19 infection, improving patients outcomes and survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
308
Tocilizumab infusion 8mg/kg/dose - Intravenous single dose.
Intravenous Non-Fractional Heparine (HNF) starting at 18UI/kg/h adjusted according to a nomogram to achieve an Activated Partial Thromboplastin Time (ATTP) from 1.5 To 2.0 times the reference Value; or Low Molecular Weight Heparin (LMWH) subcutaneous dosage of 1mg/kg per dose every 12 hours
Subcutaneous Non-Fractional Heparine 5000U every 8 hours OR Subcutaneous Low Molecular Weight (LMWH) 40mg/day.
Fundação São Francisco Xavier
Ipatinga, Minas Gerais, Brazil
UNIMED Varginha
Varginha, Minas Gerais, Brazil
Universidade Federal de Sergipe
Aracaju, Sergipe, Brazil
Proportion of patients with clinical improvement
Proportion of patients with clinical improvement in 30 days, defined by hospital discharge or a reduction of at least 2 points compared to baseline on the ordinal scale recommended by the World Health Organization: 1. Not hospitalized, with no limitations on activities; 2. Not hospitalized, but limited to activities; 3. Hospitalized, with no need for supplemental oxygen; 4. Hospitalized, needing supplemental oxygen; 5. Hospitalized, requiring high flow oxygen therapy, non-invasive mechanical ventilation or both; 6. Hospitalized, requiring ECMO, invasive mechanical ventilation or both; 7. Death.
Time frame: 30 days
Hospital and ICU length of stay;
Number of days in hospital and ICU
Time frame: 30 days
Duration of invasive mechanical ventilation
Time requiring invasive mechanical ventilation
Time frame: 30 days
Duration of vasopressor use
Time of use of vasopressors
Time frame: 30 days
Renal failure by AKIN criteria
Renal failure by AKIN criteria in 30 days
Time frame: 30 days
Incidence of cardiovascular complications
Myocardial injury; Acute myocardial infarction; Cardiogenic shock; arrhythmias; Myocarditis; Pericarditis; Ventricular dysfunction.
Time frame: 30 days
Incidence of venous thromboembolism
Deep vein thrombosis and pulmonary embolism
Time frame: 30 days
Mortality
Mortality rate
Time frame: 30, 60 and 90 days
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