EUCTR2020-005395-35-GB进行中（未招募）1 期
A randomized, controlled, Phase 2b study to evaluate safety and efficacy of rivaroxaban (Xarelto®) for high risk people with mild COVID-19 - A randomized, controlled, Phase 2b trial to evaluate safety and efficacy of rivaroxaban
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •INCLUSION CRITERIA
- •1. =18 years of age at the time of informed consent
- •Type of Participant
- •2. Participants must be at high-risk for COVID-19 progression by fulfilling at least one of the following criteria at screening:
- •- Age =65 years
- •- Presence of chronic pulmonary disease, chronic obstructive pulmonary disease (COPD), pulmonary hypertension
- •- Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment
- •- Hypertension, requiring at least one oral medication for treatment
- •- Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a CD4 T-cell count of <200/mm3)
- •- Immunocompromised status due to medication (e.g., taking 20 mg or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, cancer therapies)
- •- Any chronic disease that is associated with high risk for severe COVID disease in the opinion of the site investigator
- •- Body mass index =35 kg/m2 (based on self-reported weight and height).
- •COVID-19 Characteristics
- •3. Documented positive SARS-CoV-2 diagnostic testing with a sample collected =10 days of screening.
- •4. Symptomatic for COVID-19 for =7 days at time of randomization (symptomatic is defined as having at least one of the following symptoms of COVID-19 that is of new onset or has worsened from baseline: fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion,
- •nausea, vomiting, or diarrhoea).
- •Informed Consent
- •5. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the
- •ICF and in this protocol
- •6. Sex: Male or female Other
- •Requirements:
- •7. Agree to participate in all remote, in-person or home visits as required in the protocol and provide updated contact information as necessary.
- •8. Female of childbearing potential must agree to practice adequate contraception during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Currently hospitalized or under immediate consideration for hospitalization at screening and Day 1
- •2. Have new onset shortness of breath or increased shortness of breath from pre-COVID-19 (for people with known COPD) at screening and Day 1
- •3. Hypoxemia (oxygen saturation <94% in ambient air or oxygen saturation below pre-COVID-19 oxygen saturation [if known] for people with known COPD) at Day 1
- •4. Require supplemental oxygen (new requirement or increase in requirement from pre-COVID-19 condition) at screening and Day 1
- •5. Have a history of (in the past 3 months) or current active pathological bleeding
- •6. Have a history of haemorrhagic stroke or intracranial haemorrhage
- •7. Have a recent severe head trauma within 30 days which includes concussion, skull fracture or hospitalization for head injury
- •8. Have known intracranial neoplasm, cerebral metastases, arteriovenous malformation or aneurysm
- •9. Have history of pregnancy-related haemorrhage
- •10. Have active gastroduodenal ulcer or other gastrointestinal bleeding diagnosed in the past 3 months
- •11. Currently are in a hemodynamically unstable state
- •12. Currently require thrombolysis or pulmonary embolectomy
- •13. Have history of severe hypersensitivity reaction to Xarelto®
- •14. Currently have a prosthetic heart valve
- •15. Have known diagnosis of triple positive antiphospholipid syndrome
- •16. Have known diagnosis of chronic kidney disease (stage IV or receiving dialysis)
- •17. Have a history of thrombocytopenia or known platelet count < 100,000 cells/mm3
- •18. Have a history of bronchiectasis and pulmonary cavitation
- •19. Have active cancer (e.g., receiving chemotherapy or treatment for complication of the active cancer)
- •20. Had epidural or neuraxial anesthesia or spinal puncture in the past 2 weeks or plan to undergo these procedures during the study
- •21. Had surgery in the past 4 weeks or plan to undergo surgery during the study
- •22. Currently is pregnant or plans to become pregnant
- •23. Currently is breastfeeding
- •24. Share household with an enrolled participant in this study
- •25. Co-enrollment in any clinical trial that includes prohibited procedures (spinal puncture or surgery) or that includes treatments within the same drug class as rivaroxaban or treatments for which co-administration with rivaroxaban are prohibited Medications
- •26. Currently using and plan to use the following medications during the study
- •- Rivaroxaban or drugs in the same class
- •- Dual anti-platelets therapy
- •- Other anticoagulants
- •- Combined P-gp and CYP3A inhibitors and inducers.
研究者
相似试验
已完成
2 期
Permissive HyperthErmiA Through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit (ICU)Known or suspected infection in critically ill patients in the Intensive Care Unit (ICU)Infection - Studies of infection and infectious agentsACTRN12612000513819Medical Research Institute of New Zealand700
进行中（未招募）
不适用
A prospective randomized phase II study evaluating the monitoring of imatinib mesylate (Gliveec®) plasmatic through level in patients newly diagnosed with chronic phase chronic myelogenous leukaemia (CP-CML). - OPTIM IMATINIBChronic Phase Chronic myelogenous leukemia (CP CML)EUCTR2010-019568-35-FRCH VERSAILLES
进行中（未招募）
1 期
A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.on-Small Cell Lung CancerMedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-005476-33-FREli Lilly and Company150
进行中（未招募）
1 期
A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.on-Small Cell Lung CancerMedDRA version: 17.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-005476-33-DKEli Lilly and Company179
进行中（未招募）
不适用
A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.on-Small Cell Lung CancerMedDRA version: 17.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-005476-33-NLEli Lilly and Company179