Covid 19 Research using Clinical Trials (Home Page)
RivaroxabanWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (19)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2346 | RS blend Wiki | 0.45 |
| drug3366 | newborns from covid 19 positive mothers Wiki | 0.45 |
| drug3410 | placebo for clazakizumab Wiki | 0.45 |
| drug2917 | Thromboprophylaxis Wiki | 0.45 |
| drug1439 | Interferon-Beta Wiki | 0.45 |
| drug609 | Candesartan Wiki | 0.45 |
| drug2684 | Standard Of Care (SOC) Wiki | 0.45 |
| drug1840 | Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR Wiki | 0.45 |
| drug3416 | prayer Wiki | 0.45 |
| drug400 | Best standard of care Wiki | 0.45 |
| drug3375 | non-RAS blocking antihypertensives Wiki | 0.45 |
| drug3173 | alpha one antitrypsin inhalation Wiki | 0.45 |
| drug259 | Aspirin Wiki | 0.26 |
| drug660 | Chloroquine or Hydroxychloroquine Wiki | 0.26 |
| drug1601 | Lopinavir/Ritonavir Wiki | 0.26 |
| drug2700 | Standard of Care (SOC) Wiki | 0.22 |
| drug675 | Clazakizumab Wiki | 0.18 |
| drug703 | Colchicine Wiki | 0.14 |
| drug2122 | Placebo Wiki | 0.07 |
Correlated MeSH Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D018352 | Coronavirus Infections NIH | 0.09 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D007239 | Infection NIH | 0.02 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 5 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
Primary Outcomes
Description: composite of hospitalization or death
Measure: Outpatient trial - Colchicine vs. control and Aspirin vs. control Time: 45 days post randomizationDescription: invasive mechanical ventilation or death
Measure: Inpatient trial - Interferon-β vs. control and Colchicine vs. control Time: 45 days post randomizationDescription: invasive mechanical ventilation or death
Measure: Inpatient trial - Aspirin and rivaroxaban vs. control Time: 45 days post randomizationSecondary Outcomes
Description: disease progression by 2 points on a 7-point scale
Measure: Outpatient and Inpatient trials - Colchicine vs. control, Interferon-β vs. control Time: 45 days post randomizationDescription: composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death), and disease progression by 2 points on a 7-point scale
Measure: Outpatient and Inpatient trials - Aspirin vs. control, Aspirin and rivaroxaban vs. control Time: 45 days post randomization2 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
Primary Outcomes
Description: The primary endpoint is time to clinical improvement which is defined as time from randomization to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomization measured on a seven-category ordinal scale (proposed by WHO). The 7-categories of the World Health Organization proposed scale, as follows: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death. During hospitalization this score will be determined daily (till day 29). If a patient is released from the hospital before day 29, the score will be determined at day 11 and 29 after randomization (depending when the patient was released or by telephone call).
Measure: sustained improvement (>48h) of one point on the WHO Scale Time: Inclusion to day 29, daily evaluationSecondary Outcomes
Description: The scale described in the primary endpoint is used
Measure: Time to improvement on WHO Scale Time: Inclusion to day 29, daily evaluationDescription: The scale described in the primary endpoint is used
Measure: Mean change in the ranking on an ordinal scale from baseline Time: Inclusion to day 29, daily evaluationDescription: the National Early Warning Score includes respiratory rate, oxygen saturation, use of supplemental oxygen, temperature, systolic blood pressure, heart rate and levels of consciousness (AVPU Scale)
Measure: time to discharge or a National Early Warning Score (NEWS) ≤2 (maintained for 24h), whichever occurs first Time: Inclusion to day 29, daily evaluationDescription: The scale described in the primary endpoint is used
Measure: change from baseline in National Early Warning Score (NEWS) Time: Inclusion to day 29, daily evaluationMeasure: Oxygenation free days Time: Inclusion to day 29, daily evaluation
Description: new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation
Measure: Incidence of new oxygen use during the trial Time: Inclusion to day 29, daily evaluationMeasure: duration of oxygen use during the trial Time: Inclusion to day 29, daily evaluation
Description: number of days with requirement of mechanical ventilation
Measure: Ventilator free days until day 29 Time: Inclusion to day 29, daily evaluationMeasure: Incidence of new mechanical ventilation use during the trial Time: Inclusion to day 29, daily evaluation
Measure: duration of mechanical ventilation use during the trial Time: Inclusion to day 29, daily evaluation
Description: obtained by polymerase chain reaction in nasal/oropharyngeal swabs, performed at baseline and then three times a week, if possible
Measure: Viral load/viral clearance Time: Inclusion to day 29, daily evaluationMeasure: Duration of Hospitalization Time: Inclusion to day 29, daily evaluation
Measure: Mortality Time: 15-day, 29-day mortality
Description: BMI (kg/m2), within all subjects the impact of obesity on overall mortality will be investigated
Measure: Obesity - mortality Time: BMI at admission, mortality until day 29Description: BMI (kg/m2) , within all subjects the impact of obesity on the duration of hospitalization will be investigated
Measure: Obesity - duration of hospitalization Time: BMI at admission, duration of hospitalization until day 29 or dischargeDescription: BMI (kg/m2) , within all subjects the impact of obesity on ICU admission will be investigated
Measure: Obesity - ICU admission Time: BMI at admission, ICU admission until day 29 or dischargeDescription: BMI (kg/m2) new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation
Measure: Obesity - new oxygen use Time: BMI at admission, new oxygen use until day 29 or dischargeDescription: lopinavir and ritonavir both interact with numerous other drugs by inhibiting the cytochrome enzymes 3A4. Using commercially available drug-interaction programs, the number and severity grading of drug-drug-interactions will be documented (for instance uptodate interaction tool, medscape). This is an exploratory analysis of drug-drug interactions with the above mentioned substances. severity grading usually encompass "contraindicated", "serious", "monitor closely", "minor" interaction.
Measure: Drug-drug interactions with lopinavir/ritonavir Time: Inclusion to day 29, daily evaluationDescription: for sub-study B only: RAS fingerprint measures metabolites involved in the renin-angiotensin-system. The influence of randomized treatment with candesartan (RAS blockade) will be analyzed
Measure: Renin Angiotensin System (RAS) fingerprint Time: Inclusion to day 29, daily evaluation3 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)
Primary Outcomes
Measure: Composite endpoint of venous thromboembolism (DVT and/or fatal or non-fatal PE), arterial thromboembolism, new myocardial infarction, non-hemorrhagic stroke, all-cause mortality or progression to intubation and invasive ventilation Time: 35 days post randomizationSecondary Outcomes
Measure: Development of disseminated intravascular coagulation (DIC) according to the ISTH criteria Time: 35 days post randomizationMeasure: Number of days requiring invasive ventilation Time: 35 days post randomization
Measure: Number of days requiring non-invasive ventilation Time: 35 days post randomization
Description: scale range from 1 to 7; improvement means a reduction in the scale number of at least one point
Measure: Improvement on a seven-category ordinal scale recommended by the WHO as clinical improvement scale for patients with respiratory infections Time: 35 days post randomization4 A Randomized, Controlled, Phase 2b Study to Evaluate Safety and Efficacy of Rivaroxaban (Xarelto®) for High Risk People With Mild COVID-19
The purpose of this study is to assess safety and clinical efficacy of rivaroxaban in people with mild Coronavirus Disease 2019 who are at increased risk of disease progression.
NCT04504032 COVID-19 Drug: Rivaroxaban Drug: Placebo
Primary Outcomes
Measure: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) Time: Up to approximately 35 daysMeasure: Number of Participants With AEs Leading to Study Discontinuation Time: Up to approximately 35 days
Measure: Number of Participants With Serious Adverse Events (SAEs) Time: Up to approximately 35 days
Description: Disease progression is defined as the proportion of participants who progress to moderate or severe disease category or higher (Gates Medical Research Institute ordinal scale ≥3). The assessments will be performed using Gates Medical Research Institute ordinal scale.
Measure: Proportion of Participants With Disease Progression Time: Up to Day 28Secondary Outcomes
Description: Time to disease resolution is defined as symptoms resolution (new onset Coronavirus Disease 2019 [COVID-19] symptoms resolved, and pre-existing symptoms returned to baseline) with viral clearance (two consecutive negative diagnostic tests) through Day 28. Baseline refers to health status prior to contracting new onset COVID-19 symptoms.
Measure: Median Time to Disease Resolution Time: Up to Day 28Description: Time to disease resolution is defined as symptoms resolution only (new onset COVID-19 symptoms resolved, and preexisting symptoms returned to baseline) through Day 28. Baseline refers to health status prior to contracting new onset COVID-19 symptoms.
Measure: Median Time to Disease Resolution Time: Up to Day 28Measure: Proportion of Participants With Disease Progression Time: Days 8, 14, and 21
Measure: Proportion of Participants Who Achieve Disease Resolution Time: Days 8, 14, 21, and 28
Measure: Mean Gates Medical Research Institute Ordinal Scale Score Time: Days 8, 14, 21, and 28
Measure: Change From Baseline in Gates Medical Research Institute Ordinal Scale Score Time: Days 8, 14, 21, and 28
Measure: Mean World Health Organization Ordinal Scale Score Time: Days 8, 14, 21, and 28
Measure: Change From Baseline in World Health Organization Ordinal Scale Score Time: Days 8, 14, 21, and 28
Measure: Incidence of Hospitalization Time: Days 8, 14, 21, and 28
Measure: Number of Days of Hospitalization Time: Days 8, 14, 21, and 28
5 A Multicenter, Randomized, Placebo-Controlled, Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19 Infection
The purpose of this study is to evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic Coronavirus Disease 2019 (COVID-19) Infection.
NCT04508023 Coronavirus Disease 2019 (COVID-19) Drug: Rivaroxaban Other: Placebo Other: Standard of Care (SOC) MeSH:Coronavirus Infections
Primary Outcomes
Description: Time to first occurrence of a composite endpoint of symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, noncentral nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality will be assessed.
Measure: Time to First Occurrence of a Composite Endpoint of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, All-cause Hospitalization and All-cause Mortality Time: Up to Day 35Secondary Outcomes
Description: Time to first occurrence of a composite endpoint of symptomatic VTE, MI, ischemic stroke, acute limb ischemia, non-CNS systemic embolization, and all-cause mortality will be assessed.
Measure: Time to First Occurrence of a Composite Endpoint of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, and All-cause Mortality Time: Up to Day 35Description: Time to first occurrence of all-cause hospitalization will be assessed.
Measure: Time to First Occurrence of All-cause Hospitalization Time: Up to Day 35Description: Time to first occurrence of symptomatic VTE which includes DVT or pulmonary embolism (PE) will be assessed.
Measure: Time to First Occurrence of Symptomatic VTE Time: Up to Day 35Description: Time to first occurrence of an ER visit will be assessed.
Measure: Time to First Occurrence of an Emergency Room (ER) Visit Time: Up to Day 35Description: Time to first occurrence of symptomatic VTE, MI, ischemic stroke, acute limb ischemia, non-CNS systemic embolization, and all-cause hospitalization will be assessed.
Measure: Time to First Occurrence of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, and All-cause Hospitalization Time: Up to Day 35Description: Percentage of participants who are hospitalized or dead from any cause at Day 35 will be assessed.
Measure: Percentage of Participants who are Hospitalized or Dead From Any Cause Time: Day 35Description: Time to all-cause mortality up to Day 35 will be assessed.
Measure: Time to All-cause Mortality up to Day 35 Time: Up to Day 35Description: Time to first occurrence of ISTH critical site and fatal bleeding will be assessed.
Measure: Time to First Occurrence of International Society on Thrombosis and Hemostasis (ISTH) Critical Site and Fatal Bleeding Time: Up to 37 Days (last dose on Day 35 plus 2 Days)Description: Time to first occurrence of ISTH major bleeding will be assessed. Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.
Measure: Time to First Occurrence of ISTH Major Bleeding Events Time: Up to 37 Days (last dose on Day 35 plus 2 Days)Description: Time to first occurrence of clinically relevant non-major bleeding will be assessed. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life.
Measure: Time to First Occurrence of Clinically Relevant Non-major Bleeding Time: Up to 37 Days (last dose on Day 35 plus 2 Days)