ISRCTN57085639已完成2 期
ACCORD 2: a multicentre, seamless, Phase 2 adaptive randomisation platform study to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 in hospitalised patients
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 97 人开始时间: 2020年9月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32736596/ (added 13/08/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37868151/ (added 06/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults (=18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests
- •2. A score of Grade 3 to 5 on the 9-point ordinal scale.
- •3. Is a woman who is not of childbearing potential or The patient, and their partner(s), agree to use medically-accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom or diaphragm with spermicidal gel) during the study and for at least 6 weeks after termination of study therapy
- •4. Ability to provide informed consent signed by the study patient or legally authorised representative.
排除标准
- •1. Patients who have previously had a score of 6 or 7 on the 9-point ordinal scale
- •2. Any patient whose interests are not best served by study participation, as determined by a senior attending clinician
- •3. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >5 × the upper limit of normal (ULN)
- •4. Known active infection with HIV or hepatitis B or C
- •5. Stage 4 severe chronic kidney disease or requiring dialysis (ie, estimated glomerular filtration rate <30 ml/min/1.73 m²)
- •6. History of the following cardiac conditions:
- •6.1. Myocardial infarction within 3 months prior to the first dose
- •6.2. Unstable angina
- •6.3. History of clinically significant dysrhythmias (long QT features on electrocardiogram [ECG], sustained bradycardia [=55 bpm]), left bundle branch block, cardiac pacemaker or ventricular arrhythmia) or history of familial long QT
- •7. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) > 500 ms
- •8. Anticipated transfer to another hospital that is not a study centre within 72 hours
- •9. Allergy to any study medication
- •10. Experimental off-label usage of medicinal products as treatments for COVID-19
- •11. Patients participating in another clinical study of an investigational medicinal product
- •Sub-protocol for candidate agent Bemcentinib:
- •Additional exclusion criteria that are specific to the subprotocol are as follows:
- •12. Inability to swallow capsules (administration via nasogastric tube is permitted)
- •13. Current treatment with any agent known to cause QT prolongation. The treatment can be discontinued, with sufficient time (5 half lives) for washout, to allow inclusion of the patient
- •14. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) >450 ms
- •15. Clinically significant hypokalaemia. Individuals who do not meet this criterion may be rescreened once
- •16. Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included.
- •17. Previous bowel resection that would interfere with drug absorption
研究者
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