EUCTR2020-004571-41-LV进行中（未招募）1 期
A Randomized, Placebo Controlled, Double Blind Study to Evaluate the Safety and Efficacy of Rabeximod Compared to Standard of Care in Patients With Moderate Coronavirus Disease (COVID-19)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Cyxone AB
- 入组人数
- 300
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
- •1. Willing and able to provide written informed consent prior to performing study procedures
- •2. SARS-CoV-2 positivity of the nasal-/throat-swab/saliva swab by
- •reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested
- •by the local diagnostic laboratory = 4 days before randomization
- •3. Moderate severity of COVID -19 (See Appendix 2, FDA severity
- •categorization)
- •4. Currently hospitalized or requiring hospitalization for the COVID-19
- •medical care
- •5. Age >18 and <85 years
- •6. Presence of at least 3 of the following symptoms as present: fever,
- •cough, myalgia, fatigue
- •7. Clinical signs suggestive of moderate illness with COVID-19, such as
- •respiratory rate = 20 breaths per minute, saturation of oxygen (SpO2) >
- •93%, heart rate = 90 beats per minute = 2 days before screening
- •8. Agree to use an acceptable method of contraception for the duration
- •of the study or not be of childbearing potential. Acceptable methods of
- •birth control include: spermicide with barrier, oral, transdermal,
- •injectable, or implantable contraception, IUD, abstinence, and surgical
- •sterilization of partner. Female subjects are not of childbearing potential
- •if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal
- •ligation, or are post-menopausal by at least 12 months.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Pregnant, or intend to become pregnant or breastfeed during the
- •2. Patients who are unable to swallow the capsule.
- •3. Require invasive mechanical ventilation, including extracorporeal
- •membrane oxygenation (ECMO) at study entry.
- •4. Receiving cytotoxic or biologic treatments (such as tumor necrosis
- •factor (TNF) inhibitors, anti-interleukin-1 (IL-1), anti-IL-6 (tocilizumab
- •or sarilumab), T-cell or B-cell targeted therapies (rituximab), interferon,
- •or Janus kinase (JAK) inhibitors for any indication at study entry. A
- •washout period 4 weeks (or 5 half-lives, whichever is longer) is required
- •prior to screening.
- •5. Ever received convalescent plasma or intravenous immunoglobulin
- •(IVIg) for COVID-19.
- •6. Have received high dose corticosteroids at doses >20 mg per day (or
- •prednisone equivalent) administered for =14 consecutive days in the
- •month prior to study entry.
- •7. Have diagnosis of primary tuberculosis (TB) or, if known, latent TB
- •treated for less than 4 weeks with appropriate anti-tuberculosis therapy
- •per local guidelines (by history only, no screening tests required).
- •8. Suspected serious, active bacterial, fungal, viral, or other infection
- •(besides COVID-19) that in the opinion of the investigator could
- •constitute a risk when taking investigational product.
- •9. Have received any live vaccine within 4 weeks before screening, or
- •intend to receive a live vaccine during the study. Use of non-live
- •(inactivated) vaccinations is allowed
- •10. Current diagnosis of active malignancy that, in the opinion of the
- •investigator, could constitute a risk when taking investigational product.
- •11. Have a history of venous thromboembolism (VTE) (deep vein
- •thrombosis (DVT) and pulmonary embolism (PE) within 12 weeks prior
- •to randomization or have a history of recurrent (>1) VTE (DVT/PE).
- •12. Anticipated discharge from the hospital, or transfer to another
- •hospital (or another unit), which is not a study site within 72 hours after
- •study entry.
- •13. Have neutropenia (absolute neutrophil count <1000 cells/mLµL).
- •14. Have lymphopenia (absolute lymphocyte count <200 cells/mLµL).
- •15. Have alanine aminotransferase (ALT) or aspartate aminotransferase
- •(AST) >5x ULN.
- •16. Have total bilirubin > 1.5 x upper limit of normal.
- •17. Estimated glomerular filtration rate (eGFR) <30
- •milliliter/minute/1.73 m2.
- •18. Have a known hypersensitivity to rabeximod or any of its
- •excipients.
- •19. Are currently enrolled in any other clinical study involving an
- •investigation product or any other type of medical research judged not
- •to be scientifically or medically compatible with this study. The
- •participant should not be enrolled (start) in another clinical trial for the
- •treatment of COVID-19 or SARS CoV-2 through Day 28.
- •20. Are using or will use extracorporeal blood purification (EBP) device
- •to remove proinflammatory cytokines from the blood such as a cytokine
- •absorption or filtering device, for example, CytoSorb®.
- •21. Are unlikely to survive for at least 48 hours after screening in the
- 另有 1 项未显示
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Placebo Controlled, Double Blind Study to Evaluate the Safety and Efficacy of Rabeximod Compared to Standard of Care in Patients With Moderate Coronavirus Disease (COVID-19)Coronavirus Disease (COVID-19)MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862EUCTR2020-004571-41-HUCyxone AB300
进行中（未招募）
1 期
A study to learn how well the drug Rabeximod works and how safe Rabeximod is in people who have Moderate Coronavirus Disease (COVID-19)Coronavirus Disease (COVID-19)MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862EUCTR2020-004571-41-SKCyxone AB300
进行中（未招募）
不适用
A Randomized, Placebo-controlled, Double-blind Study of LY2216684 Fixed-dose 12 mg and 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment - Am bMajor depressive disorder (MDD)MedDRA version: 12.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSEUCTR2010-021214-39-LVEli Lilly and Company1,893
已完成
不适用
Research study to investigate the safety, tolerability and effects of multiple doses of LTI-291 in healthy middle aged and older volunteers.GBA-Associated parkinsonism, movement disorderNL-OMON24313•Lysosomal Therapeutics Incorporated40
已完成
不适用
A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of LTI-291 in Healthy Middle-Aged to Elderly SubjectsGBA-Associated Parkinson's Diseasemovement disorder10028037NL-OMON44195ysosomal Therapeutics Incorperated.40