There are 3 clinical trials

Clinical Trials

1 Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial

ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.

NCT04324463 Coronavirus Severe Acute Respiratory Syndrome Drug: Colchicine Drug: Interferon-Beta Drug: Aspirin Drug: Rivaroxaban

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

2 A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2)

The Austrian Coronavirus Adaptive Clinical Trial (ACOVACT) is a randomized, controlled, multicenter, open-label basket trial that aims to compare various antiviral treatments for COVID-19. Moreover three substudies have been integrated. Currently, patients will be randomized to receive (hydroxy-)chloroquine, lopinavir/ritonavir or standard of care. Moreover, these patients are eligible for substudy A (randomized to rivaroxaban 5mg 1-0-1 vs. standard of care), substudy B (renin-angiotensin (RAS) blockade vs. no RAS blockade for patients with blood pressure >120/80mmHg), and substudy C (clazakizumab vs standard of care, for patients with respiratory deterioration and high inflammatory biomarkers). Endpoints were chosen based on the master protocol published by the World Health Organisation and include a 7-point scale of clinical performance, mortality, oxygen requirement (both dose and type), duration of hospitalization, viral load and safety.

NCT04351724 COVID-19 Drug: Chloroquine or Hydroxychloroquine Drug: Lopinavir/Ritonavir Other: Best standard of care Drug: Rivaroxaban Drug: Thromboprophylaxis Drug: Candesartan Drug: non-RAS blocking antihypertensives Drug: Clazakizumab Drug: placebo for clazakizumab

MeSH:Coronavirus Infections

3 Effect of Anticoagulation Therapy on Clinical Outcomes in Moderate to Severe Coronavirus Disease 2019 (COVID-19)

Patients with moderate to severe COVID-19 present a very high risk of thromboembolic disease.This multicenter, prospective, randomized, event-driven study evaluates rivaroxaban compared with standard of care including low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) at prophylactic doses if applicable in the prevention of the composite of venous thromboembolism (deep vein thrombosis and/or fatal or non-fatal pulmonary embolism), arterial thromboembolism, new myocardial infarction, non-hemorrhagic stroke, all-cause mortality or progression to intubation and invasive ventilation 35 days post randomization in patients with moderate to severe COVID-19. Experimental intervention/Index test: Patients randomized into the rivaroxaban arm will receive rivaroxaban 20 mg once daily (OD) until day 7 post randomization or hospital discharge, whichever occurs later, followed by a 28-day-phase of prophylactic anticoagulation with rivaroxaban 10mg OD. Subjects with an eGFR between 30 and 50ml/min/1,73m2, will receive 15mg instead of 20mg OD. Control intervention/Reference test: The control group will receive standard of care including LMWH or UFH as thromboprophylaxis or no anticoagulation, if appropriate. Duration of intervention per patient: The total duration of the study treatment is flexible. For out-patients 7 days of therapeutic anticoagulation will be accompanied by 28 days-phase of prophylactic anticoagulation, summing up to 35 days. For subjects that require hospitalization, the duration of therapeutic anticoagulation will be at least 7 days or prolonged until discharge if hospitalized for more than 7 days post randomization. After discharge from the hospital the subject receives 28 days of thromboprophylaxis with rivaroxaban. No study medication will be given past day 60 post randomization. This adds up to a study duration between 35 and 60 days depending on the duration of the hospital stay. Follow-up per patient: The study has a follow-up of 60 days. Experimental and/or control off label or on label in Germany: Rivaroxaban has been approved for multiple indications worldwide. Over 100,000 subjects have been studied from Phase 1 through multiple large Phase 4 studies in multiple settings, e.g. for the reduction in the risk of stroke and systemic embolism in arterial fibrillation, deep vein thrombosis and pulmonary embolism, major cardiovascular events. The drug had not been studied in patients with COVID-19 as an anticoagulant agent, yet.

NCT04416048 COVID-19 Drug: Rivaroxaban Other: Standard Of Care (SOC)

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