A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 10
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
This study evaluates the efficacy and safety of efprezimod alfa in hospitalized adult participants who are diagnosed with coronavirus disease 2019 (COVID-19) and receiving oxygen support.
The primary hypothesis of the study is clinical improvement in the experimental group versus the control group.
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
- •Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acute respiratory syndrome coronavirus 2 (SARS-coV-2) viral infection
- •Severe or critical COVID-19, or National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal score 2, 3 or 4 (Scale 2: requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Scale 3: non-invasive ventilation or high flow oxygen devices; Scale 4: supplemental oxygen support; a peripheral capillary oxygen saturation (SpO2) </= 94% or tachypnea (respiratory rate >/= 24 breaths/min). Intubation should be within 7 days
排除标准
- •Participants who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment
- •Participants previously enrolled in the efprezimod alfa study
- •Intubation for invasive mechanical ventilation is over 7 days
- •Documented acute renal or hepatic failure
- •The investigator believes that participating in the trial is not in the best interests of the participant, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues)
研究组 & 干预措施
Efprezimod alfa
Participants receive single dose of 480 mg efprezimod alfa, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
干预措施: Efprezimod alfa (Drug)
Placebo
Participants receive single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes, on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to 30 days
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, only AEs with Common Terminology Criteria for AE (CTACAE) grade ≥3 were included. The number of participants who experienced an AE were reported.
Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status
时间窗: Up to Day 29
Time to improvement in COVID-19 clinical status: defined as time (days) required from start of treatment to improvement of clinical status severe - moderate/mild or improvement from score 2-4 to ≥5 sustained without drop below 5 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up) per National Institute of Allergy \& Infectious Diseases (NIAID) ordinal scale graded: 1=Death; 2=Hospitalized, on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO); 3=Hospitalized, on non-invasive ventilation (NIV)/high flow oxygen devices; 4=Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, don't require medical care; 7=Not hospitalized, limitation on activities \&/or require home oxygen; 8=Not hospitalized, no limitations on activities. Median time \& 95% confidence intervals (CIs) were reported using Brookmeyer-Crowley method.
次要结局
- Rate of Clinical Relapse(Up to Day 29)
- Time to Disease Progression in Clinical Status of COVID-19(Up to Day 29)
- Conversion Rate of COVID-19 Clinical Status(Up to Day 15)
- Duration of MV(Up to Day 29)
- Duration of High Flow Oxygen Therapy(Up to Day 29)
- Length of Hospital Stay(Up to 90 days)
- Time to Hospital Discharge(Up to Day 29)
- Number of Participants Who Died Due to Any Cause(Up to Day 29)
- Change From Baseline in Absolute Lymphocyte Count(Baseline and up to Day 15)
- Percentage of Participants Who Died or Had Respiratory Failure (RF)(Up to Day 29)
- Duration of Pressors(Up to Day 29)
- Duration of ECMO(Up to Day 29)
- Change From Baseline in D-Dimer Concentration(Baseline and up to Day 15)