ACTRN12620000445976招募中3 期
Australasian COVID-19 Trial (ASCOT): An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess Different Treatment Regimens on the Clinical, Virological and Immunological Outcomes in Patients Diagnosed with SARS-CoV-2 Infection (COVID-19).
niversity of Melbourne0 个研究点目标入组 2,200 人开始时间: 2020年4月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •Core Platform Inclusion Criteria (all participants must meet the following):
- •Adult (as defined by local jurisdiction) patient admitted to hospital with acute illness and suspected or proven SARS-CoV-2 infection.
- •Antiviral II Inclusion Criteria (all patients at sites participating in the Antiviral II Domain must meet the following) :
- •SARS-CoV-2 infection has been confirmed by positive rapid antigen test OR polymerase chain reaction test within the last 7 days
排除标准
- •A. Core Platform Exclusion Criteria (all participants must not meet the following):
- •1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
- •2. Patient is expected to be discharged from hospital today or tomorrow
- •3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to proven SARS-CoV-2 infection
- •4. Previous participation in this trial, or another trial that is analysed within the same statistical model as this trial, within the last 90 days
- •B. Antiviral II Domain Exclusion Criteria (all patients at sites participating in the Antiviral II Domain must not meet the following):
- •1.Severe renal impairment, defined as eGFR<30ml/min or receipt of renal replacement therapy
- •2.Severe hepatic impairment, defined as proven or suspected cirrhosis with Child Pugh class of C, OR acute hepatitis, defined as AST or ALT>5 times the upper limit of normal in the testing laboratory.
- •3.The patient has received, at the time of eligibility assessment, >24h of an antiviral agent intended to have activity against SARS-CoV-2, within the past 7 days
- •4.The patient is known to be pregnant or breastfeeding
- •5.The treating clinician believes that participation in the domain would not be in the best interests of the patient
- •B.1. Antiviral II Domain Non-Immune Suppressed Stratum-specific Exclusion Criteria (all non-immune suppressed patients at sites participating in the Antiviral II Domain must not meet the following):
- •1. Onset of COVID-related symptoms was more than 7 days (i.e., 168 hours) ago
- •B2. Antiviral II domain Intervention-specific Exclusion Criteria (All patients at sites participating in the Antiviral II Domain will be excluded from the below interventions if they meet the following):
- •Will be excluded from receiving Remdesivir if:
- •1 No venous access is available and none can be created
- •2 Known hypersensitivity to remdesivir or its excipients
- •Will be excluded from receiving Nirmatrelvir/ritonavir if:
- •1 The patient is unable to take, tolerate or absorb oral or enteral medications
- •2 Known hypersensitivity to any of nirmatrelvir, ritonavir or its excipients
- •3 Receipt of a concomitant drug with a high-risk interaction with nirmatrelvir-ritonavir which cannot be ceased or substituted.
- •Will be excluded from receiving no antiviral agent if:
- •1. The patient is in the Immune Suppressed Stratum
- •2. The patient is receiving or has received supplemental oxygen on the calendar day of eligibility assessment.
- •3. The patient is considered by the treating clinician to be at very high risk for progression to severe COVID-19
研究者
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