COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-949z6v

Carlos Miranda

chmiranda@fmrp.usp.br

2020-05-06

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Age above or equal to 18 years, SARS-covid-19 infection confirmed through RT-PCR, Severe forms confirmed by the presence of ARDS according to the Berlin classification ( bilateral infiltrate on chest X-ray, arterial hypoxemia with a PaO2 / FIO2 ratio <300, absence of structural heart disease or evidence of insufficiency acute cardiac arrest, Presence of severe clinical presentation with respiratory failure requiring orotracheal intubation or mechanical ventilation or maintenance of RF> 24 ipm and saturation <90% after the administration of supplemental oxygen through a nasal catheter at 4 liters / min, Dosage of D-dimer greater than and equal to 0.5 pg / ml, Presence of prothrombin time (TP / INR) <1.5 and APTT (activated partial thromboplastin time (APTT) <1.5, Platelet count greater than 100,000 / mm3

Age over 85 years, creatinine clearance <10 ml / min, severe circulatory shock with a dose of norepinephrine greater than 1.0 pg / Kg / min, Chronic renal patients on hemodialysis, chronic Child B and C liver disease, advanced diseases (active neoplasia, heart failure functional class III and IV, COPD in chronic use of oxygen with more than 2 exacerbations in the last year, advanced dementia, bedridden patient with significant sequelae of stroke or traumatic brain injury, cardiorespiratory arrest, pregnant women, recent major surgery in the last 3 weeks, recent stroke in the last 3 months, presence of active bleeding, presence of blood dyscrasia such as: hemophilia, Von Willebrand factor deficiency, etc., participation in another clinical investigation with associated intervention, formal indication for oral anticoagulation for other reasons such as: pulmonary embolism, acute coronary syndrome, etc.

2

Faculdade de Medicina de Ribeirão Preto

18

85

Brazil

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

0

Evaluation of gas exchange between D0 / D4 /D7 /D14 evaluated through the PO2 / FIO2 ratio; days without mechanical ventilation (within 28 days of follow-up; how many days were out of mechanical ventilation; if the patient dies before 28 days of follow-up; it is considered that he did not stay any day out of mechanical ventilation)

Phase 2

[{"arm_notes": "Full heparinization with enoxaparin", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Prophylactic heparinization with unfractionated heparin or enoxaparin", "treatment_id": 464, "treatment_name": "Enoxaparin or unfractionated heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]