COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04662684

Eduardo Ramacciotti, MD, PhD

ramacciotti@svriglobal.com

2020-12-10

Completed

RCT

Randomized

Parallel

Open label

single-center

Long covid

inclusion criteria: - male and nonpregnant female patients 18 years of age or older - positive reverse-transcriptase-polymerase-chain-reaction (rt-pcr) assay for sars-cov-2 in a respiratory tract sample - pneumonia confirmed by chest imaging - additional risk factors for vte, as indicated by a total modified international medical prevention registry on venous thromboembolism (improve) risk score of 4 or higher - have received thromboprophylaxis with low-molecular-weight heparin, fondaparinux, or unfractionated heparin during the index hospitalization

- age < 18 years - refusal of informed consent - physician decision that involvement in the trial was not in the patient's best interest - patients with a medical indication for anticoagulation therapy at the time of inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis) - platelets < 50,000 / mm3 - patients with contraindications to anticoagulation (active bleeding, liver failure, blood dyscrasia, or prohibitive hemorrhagic risk in the investigator's assessment) - active cancer (excluding non-melanoma skin cancer) defined as cancer, not in remission or requiring active chemotherapy or adjunctive therapies such as immunotherapy or radiotherapy. - use of strong inhibitors of cytochrome p450 (cyp) 3a4 and/or glycoprotein p (p-gp) (eg protease inhibitors, ketoconazole, itraconazole) and/or use of p-gp and strong inducers of cyp3a4 (how but not limiting rifampicin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine or st. john's wort) - creatinine clearance <30 ml / min - pregnancy or breastfeeding - known hiv infection - presence of one of the following uncontrolled or unstable cardiovascular diseases: stroke, ecg confirmed acute ischemia or myocardial infarction, and/or clinically significant dysrhythmia

2

Science Valley Research Institute

18

90

Brazil

Patients recovered from covid

N/A

320

Venous thromboembolism and VTE related-death

None

Phase 3

[{"arm_notes": "", "treatment_id": 1124, "treatment_name": "Rivaroxaban", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]