A Multicentre, Phase 2, Randomised Study to Assess the Efficacy and Safety of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 12
- 主要终点
- Time to Sustained Clinical Improvement of at Least 2 Points
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of bemcentinib as an add-on therapies to standard of care (SoC) in participants hospitalized with coronavirus disease 2019 (COVID-19).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (greater than or equal to [>=] 18 years) with SARS-CoV-2 infection.
- •Participants with symptoms and/or signs consistent with COVID-19, requiring treatment.
- •A score of Grade 3 to 5 on the 9-point ordinal scale. In India; only Participants with a score of Grade 4 or 5 will be enrolled.
- •a) Male Participants:
- •A male Participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- •b) Female Participants:
- •A female Participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •Not a woman of childbearing potential. OR
- •A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- •Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded).
- •Ability to provide informed consent signed by the study Participant or legally authorized representative.
排除标准
- •Participants who have previously had a score of 6 or 7 on the 9-point ordinal scale.
- •Inability to swallow capsules (administration via nasogastric tube is permitted in Participants who become unable to swallow after starting the study drug).
- •History of the following cardiac conditions:
- •Myocardial infarction within 3 months prior to the first dose
- •Unstable angina
- •History of clinically significant dysrhythmias (long QT features on electrocardiogram [ECG], sustained bradycardia [less than or equal to {<=} 55 beats per minute {bpm}]), left bundle branch block, or ventricular arrhythmia) or history of familial long QT. Participants with an implantable cardioverter defibrillator device in place, will be allowed to enroll. Atrial fibrillation will not be a reason for exclusion.
- •Screening 12-lead ECG with a measurable QT interval according to Fridericia correction (QTcF) greater than (>) 470 msec.
- •Clinically significant hypokalaemia.
- •Therapeutic anticoagulation with vitamin K antagonists.
- •Previous bowel resection that would interfere with drug absorption.
- •Any participant whose interests are not best served by study participation, as determined by a senior attending clinician.
- •Alanine aminotransferase/aspartate aminotransferase >5 × the upper limit of normal.
- •Current treatment for human immunodeficiency virus (HIV) or tuberculosis (TB).
- •Positive serologic assay at screening for hepatitis B virus (Hep B surface antigen) or hepatitis C virus (hepatitis C PCR or hepatitis C core antigen) at local laboratory.
- •Stage 4 severe chronic kidney disease.
- •Anticipated transfer to another hospital that is not a study center within 72 hours.
- •Allergy to any study treatment.
- •Experimental off-label usage of medicinal products as treatments for COVID-19 at the time of enrolment.
- •Participants participating in another clinical study of an investigational medicinal product.
- •Current or planned treatment for TB.
研究组 & 干预措施
Standard of Care + Bemcentinib
Bemcentinib will be administered for up to 15 days, or until discharge from hospital, whichever comes sooner. SoC will be administered based on local guidelines.
干预措施: Bemcentinib (Drug)
Standard of Care + Bemcentinib
Bemcentinib will be administered for up to 15 days, or until discharge from hospital, whichever comes sooner. SoC will be administered based on local guidelines.
干预措施: SoC (Other)
Standard of Care
The SoC will be administered based on local guidelines in place at the time of treatment during the study.
干预措施: SoC (Other)
结局指标
主要结局
Time to Sustained Clinical Improvement of at Least 2 Points
时间窗: From randomization up to Day 29
Sustained clinical improvement is defined as improvement without subsequent worsening. Time to sustained clinical improvement (in days) from randomization is defined as the number of days to a sustained improvement of at least 2 points on a 9-point category ordinal scale, or live discharge from the hospital, or fit for discharge, whichever occurs first by Day 29. 9-point category ordinal scale: 0-Uninfected, no clinical or virological evidence of infection; 1-Ambulatory, no limitation of activities; 2-Ambulatory, limitation of activities; 3-Hospitalised - mild disease, no oxygen therapy; 4-Hospitalized - mild disease, oxygen by mask or nasal prongs; 5-Hospitalized - severe disease, non-invasive ventilation or high-flow oxygen; 6-Hospitalized - severe disease, intubation and mechanical ventilation; 7-Hospitalized - severe disease, ventilation and additional organ support - vasopressors, renal replacement therapy, extracorporeal membrane oxygenation; 8-Death.
次要结局
- Number of Participants With Any Form of New Ventilation Use(Up to Day 29)
- Percentage of Participants Not Deteriorating According to the Ordinal Scale by 1, 2, or 3 Points(At Days 2, 8, 15, and 29)
- Duration of Oxygen Use (in Percentage)(Up to Day 29)
- Duration of Oxygen-free Days (in Percentage)(Up to Day 29)
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load(Day 1 (Baseline), 3, 5, 8, 11, 15, and 29)
- Duration of Ventilation Use (in Percentage) by Hospital Survival Status(Up to Day 29)
- Duration of Ventilation-free Days (in Percentage)- by Hospital Survival Status(Up to Day 29)
- Duration of New Ventilation Use (in Percentage) by Hospital Survival Status(Up to Day 29)
- Duration of Organ Support (in Percentage)(Up to Day 29)
- Number of Participants With Response(At Days 2, 8, 15, and 29)
- Time to Live Discharge From the Hospital(Up to Day 29)
- Time to Death(Up to Day 60)
- Overall Mortality(At Days 15, 29, and 60)
- Change From Baseline in the Ratio of Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2)(Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15)
- Number of Participants With Adverse Events (AEs)(Up to Day 90)
- Duration of Intensive Care Unit (ICU)- (in Percentage)(Up to 90 days)
- Duration of Hospitalization(Up to 90 days)
- National Early Warning Score 2 (NEWS2)(At Days 15 and 29)
- Time to NEWS2 of <=2, Maintained for at Least 24 Hours(Up to Day 29)
- Ranked Trajectory Over 29 Days(29 days)