COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04600141

Ludhmila Abrahão Hajjar MD, PhD, University of Sao Paulo

Not reported

2020-10-23

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - age ≥ 18 years; - informed consent form signed by the patient or guardian or by audio with the guardian; - positive result for covid-19 in pcr (polymerase chain reaction) in nasopharyngeal swab or tracheal secretion up to 10 days before the inclusion and radiological evidence of covid-19, by chest radiography or chest computed tomography; - need for ≥ 4 l of supplemental oxygen to maintain peripheral oxygen saturation equal to or greater than 93% or need for invasive mechanical ventilation.

- risk of bleeding: - clinical: active bleeding, major surgery in the last 30 days, gastrointestinal bleeding within 30 days; - laboratory: platelet count <50,000, inr> 2 or aptt> 50s; - 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.

4

University of Sao Paulo

18

100

Brazil

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

308

Proportion of patients with clinical improvement

None

Phase 3

[{"arm_notes": "Therapeutic dosage", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Prophylactic dosage", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Therapeutic dosage+8mg/kg/dose", "treatment_id": 2267, "treatment_name": "Tocilizumab+unfractioned heparin", "treatment_type": "Interleukin inhibitors+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Prophylactic dosage+8mg/kg/dose", "treatment_id": 2267, "treatment_name": "Tocilizumab+unfractioned heparin", "treatment_type": "Interleukin inhibitors+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]