A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H5: MP0420)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 105
- 主要终点
- Number of Participants With Sustained Recovery
研究概览
简要总结
This study looks at the safety and effectiveness of MP0420 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either MP0420 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H5.
详细描述
This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of MP0420 in hospitalized patients infected with COVID-19.
This is a randomized, blinded, controlled sub-study of MP0420 plus current SOC against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo.
Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2).
An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. At the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5.
If MP0420 passes the futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm, or futility for the investigational agent. Participants will be followed for 18 months following randomization.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Refer to the master protocol (NCT04501978)
排除标准
- •Refer to the master protocol (NCT04501978)
- •Additional Exclusion Criteria:
- •Pregnant women
- •Nursing mothers
- •Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 11 weeks after receiving MP0420/placebo
- •Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 11 weeks after receiving MP0420/placebo.
研究组 & 干预措施
MP0420 plus SOC
- MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion
- Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
干预措施: MP0420 (Drug)
MP0420 plus SOC
- MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion
- Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
干预措施: Remdesivir (Biological)
Placebo plus SOC
- Placebo administered by IV infusion
- Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
干预措施: Placebo (Drug)
Placebo plus SOC
- Placebo administered by IV infusion
- Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
干预措施: Remdesivir (Biological)
结局指标
主要结局
Number of Participants With Sustained Recovery
时间窗: Through Day 90
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Number of Participants With an Ordinal Outcome on Day 5
时间窗: Status on Day 5
Ordinal outcome with 7 mutually exclusive categories
次要结局
- Number of Participants Who Died From All Causes(Through Day 90)
- Number of Participants With a Safety Outcome Through Day 5(Through Day 5)
- Number of Participants With a Safety Outcome Through Day 28(Through Day 28)
- Number of Participants With a Safety Outcome Through Day 90(Through Day 90)