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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Therapeutic anticoagulation | Active Comparator |
|
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| Group 2 - Prophylactic anticoagulation | Active Comparator |
|
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| Group 3 - Therapeutic anticoagulation with tocilizumab | Experimental |
|
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| Group 4 - Prophylactic anticoagulation with tocilizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab infusion 8mg/kg/dose - Intravenous single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital and ICU length of stay; | Number of days in hospital and ICU | 30 days |
| Duration of invasive mechanical ventilation | Time requiring invasive mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
Risk of bleeding:
Known or suspected adverse reaction to UFH, including heparin-induced thrombocytopenia (TIH);
Adverse reaction or allergy to tocilizumab;
Use of any of the following treatments: UFH to treat a thrombotic event within 12 hours before inclusion; HPBM in therapeutic dose within 12 hours before inclusion; warfarin (if used 7 days before and if INR greater than 2; thrombolytic therapy within 3 days before; and use of glycoprotein IIb / IIIa inhibitors within the previous 7 days;
Pregnant or lactating;
Absolute indication of anticoagulation due to atrial fibrillation or diagnosed thromboembolic event;
Refusal by family members and / or patient;
Active tuberculosis;
Bacterial infection confirmed by culture;
Neutropenia (<1000 neutrophils / mm3);
Use of another immunosuppressive therapy that is not a corticosteroid;
Septic shock.
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| Name | Affiliation | Role |
|---|---|---|
| Ludhmila A Hajjar, MD, PhD | InCor - University of Sao Paulo Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundação São Francisco Xavier | Ipatinga | Minas Gerais | Brazil | |||
| UNIMED Varginha |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Heparin - Therapeutic dosage | Drug | 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 |
|
| Heparin - Prophylactic dosage | Drug | Subcutaneous Non-Fractional Heparine 5000U every 8 hours OR Subcutaneous Low Molecular Weight (LMWH) 40mg/day. |
|
| 30 days |
| Duration of vasopressor use | Time of use of vasopressors | 30 days |
| Renal failure by AKIN criteria | Renal failure by AKIN criteria in 30 days | 30 days |
| Incidence of cardiovascular complications | Myocardial injury; Acute myocardial infarction; Cardiogenic shock; arrhythmias; Myocarditis; Pericarditis; Ventricular dysfunction. | 30 days |
| Incidence of venous thromboembolism | Deep vein thrombosis and pulmonary embolism | 30 days |
| Mortality | Mortality rate | 30, 60 and 90 days |
| Varginha |
| Minas Gerais |
| Brazil |
| Universidade Federal de Sergipe | Aracaju | Sergipe | Brazil |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |