RBR-2kjm6y
招募中
2 期
A phase 2 randomized double-blind placebo-controlled study to evaluate safety and antiviral activity of BLD-2660 in hospitalized subjects with recently diagnosed COVID-19 compared to standard of care treatment
Blade Therapeutics Inc0 个研究点2020年8月26日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Blade Therapeutics Inc
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •At least 18 years of age at the time of signing the ICF. Hospitalized for COVID\-19\. Diagnosed with COVID\-19 as defined by having at least 2 of the following signs or symptoms within the past 2 days: a.fever defined as a body temperature higher than 38\.0°C oral, or higher than 38\.3°C rectal, higher than 37\.7°C forehead or higher than 38\.7°C aural (axillary temperatures are not allowable); b.cough; c.fatigue; d.shortness of breath. Radiographic evidence (chest x\-ray or CT scan) of one the following: a. ground\-glass opacities, or b.local or bilateral patchy infiltrates, or c.interstitial pulmonary infiltrates. Oxygen requirements: a. spO2 higher than 94% on ambient air or b.requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device. Male and/or female subjects. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All subjects (male or female) who are of childbearing potential must agree to use highly effective contraception during the study. Female subjects and male partners of female subjects must continue to use highly effective contraception for 30 days after the last dose of study drug. Female subjects should not donate oocytes during this time. Male subjects and female partners of male subjects must continue to use highly effective contraception for 90 days. Male subjects must agree not to donate sperm during this time. Women of childbearing potential must have a negative serum pregnancy test at screening within 72 hours prior to first administration of study drug. Women not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 1 year. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
排除标准
- •Active bacterial pneumonia infection. Known active tuberculosis (TB). History of Child\-Pugh B or C cirrhosis. History of ischemic heart disease or myocardial infarction or acute coronary syndrome. Subjects requiring supplemental oxygen higher than 0\.75 FiO2\. It is not in the best interest of the subjects to participate, in the opinion of the treating
- •Investigator. Female subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study drug. The following laboratory parameters are excluded:
- •alanine aminotransferase (ALT) or aspartate aminotransferase (AST) higher than 5 x upper limit of normal (ULN); creatinine clearance lower than 50 mL/min. Requiring, or expected to require mechanical ventilation at screening. Treatment with chloroquine or hydroxychloroquine at study entry. Treatment with anti\-IL\-6, anti\-IL\-6 receptor antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period. Participation in any other clinical study of an experimental drug treatment for COVID\-19 within 6 half\-lives of the experimental treatment. Current participation or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug. Unable to swallow solid oral medication or known malabsorption disorder. Subjects who have allergy to BLD\-2660 or inactive components of BLD\-2660
结局指标
主要结局
未指定
相似试验
进行中（未招募）
不适用
A Phase II randomized double-blind placebo-controlled Study of KC706 in patients with rheumatoid arthritis inadequately controlled with a stable dose of methotrexateActive rheumatoid arthritis (RA), patients taking stable doses of methotrexateMedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2006-002645-37-HUKémia, Inc.150
招募中
不适用
A treatment for brain damage in successfully resuscitated cardiac arrest patientsDiseases of the circulatory systemKCT0007235GNT Pharma150
已完成
2 期
Phase II study of KRP-N118 in patients with Nocturia due to nocturnal polyuriaocturia due to nocturnal polyuria.JPRN-jRCT2080224041Kyorin Pharmaceutical Co.,LTD880
进行中（未招募）
不适用
A randomized phase 2 double-blind, placebo-controlled study of GK-001 in hepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatmentEUCTR2008-000566-23-FRGeneCare Research Institute Co., Ltd.102
进行中（未招募）
不适用
A randomized phase 2 double-blind, placebo-controlled study of GK-001 in hepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatment Estudio aleatorizado de fase 2, doble ciego, controlado con placebo sobre GK-001 en pacientes con carcinoma hepatocelular (CHC) y hepatitis C crónica tras tratamiento curativo para el CHChepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatment carcinoma hepatocelular (CHC) en pacientes con hepatitis C crónica tras tratamiento curativo para el CHCMedDRA version: 9.1Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectableEUCTR2008-000566-23-ESGeneCare Research Institute Co., Ltd.102