A Randomized, Double-blind, Placebo-controlled, Multicenter, Proof-of-concept, Phase IIA Study of MP1032 Plus Standard of Care vs Standard of Care in the Treatment of Hospitalized Participants With Moderate to Severe COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 31
- 主要终点
- Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to severe 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant is admitted to hospital and has a positive severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) test by standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test
- •Participant has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19
排除标准
- •Participant, in opinion of the investigator, is not likely to survive >=48 hours beyond Day 1
- •Participant has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1
- •Participant has a documented medical history of infection with hepatitis A, B, C, or with human immunodeficiency virus (with a detectable viral load and CD4 count <500 cells per micro liter), or a documented active infection with tuberculosis.
- •The Participant has clinically significant electrocardiogram (ECG) abnormalities at screening
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
MP1032
Participants will receive MP1032 300 milligrams (mg) twice daily (BID) with hospital selected SoC for 28 days.
干预措施: MP1032 (Drug)
Placebo
Participants will receive placebo matched to MP1032 with hospital selected SoC for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14
时间窗: At Day 14
Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.
次要结局
- Percentage of Participants With Disease Resolution at Day 14(At Day 14)
- Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28(At Day 14 and Day 28)
- Time to Discharge by Day 28 and Day 60(Baseline, Day 28 and Day 60)
- Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60(At Day 14, Day 28 and Day 60)
- Number of Participants With Clinically Significant Change in Vital Sign(Day 1 up to Day 60)
- Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032(Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7)
- Percentage of Participants With Disease Resolution at Day 28(At Day 28)
- All-cause Mortality Rate up to Day 28(Up to Day 28)
- Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28(Baseline, Day 28)
- All-cause Mortality Rate up to Day 14 and Day 60(Up to Day 14 and Day 60)
- Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14(Baseline, Day 14)
- Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28(At Day 28)
- Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit(Baseline up to Day 60)
- Percentage of Participants With Clinical Status Improvement of at Least 1 Category From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28(Baseline, Day 14 and Day 28)
- Apparent Elimination Rate Constant (Kel) of MP1032(Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1)
- Apparent Body Clearance (CL/F) of MP1032(Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1)
- Apparent Volume of Distribution (Vz/F) of MP1032(Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1)
- Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032(Pre-dose concentration (Day 2, Day 7, and Day 8).)
- Average Observed Plasma Concentration at Steady State of MP1032(Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7)
- Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale(Baseline up to Day 28)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs(Day 1 up to Day 60)
- Number of Participants With Clinically Significant Abnormalities in Physical Examinations(Baseline up to Day 60)
- Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results(Baseline up to Day 60)
- Maximum Observed Plasma Concentration (Cmax) of MP1032(Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7)