A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of M5049 in Hospitalized Participants With COVID-19 Pneumonia (ANEMONE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 21
- 主要终点
- Time to Recovery
研究概览
简要总结
The study will evaluate the safety and efficacy of orally-administered M5049 in Coronavirus disease 2019 (COVID-19) pneumonia participants who are hospitalized but not on mechanical ventilation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant provides signed informed consent prior to the initiation of any study assessments
- •Has laboratory-confirmed SARS-CoV-2 Infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization
- •Has chest imaging consistent with COVID-19 pneumonia (as per locally accepted guidelines) If chest imaging is not available during Screening, please discuss with Medical Monitor or designee regarding evidence of probable COVID-19 pneumonia for study participant eligibility
- •Not on mechanical ventilation or ECMO
- •Has an SpO2 less than (<) 94 percent in room air And able to maintain a partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) greater than or equal to (>=) 150 (Or equivalent SpO2/FiO2 >=190) with a maximum FiO2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 Liter), assess their current baseline oxygen requirements for eligibility
- •Requires hospitalization
- •Other protocol defined inclusion criteria may apply
排除标准
- •Any condition that could interfere with the study objectives, conduct or evaluation in the opinion of the Investigator or Sponsor or designee
- •Significantly uncontrolled medical illness (eg, cardiovascular disease, hypertension, diabetes mellitus, obstructive lung disease, neurological associated with seizures (example: cerebrovascular accident/stroke, acute brain infection, traumatic brain injury, progressive brain disease, congenital brain disease or neuropsychiatric disorder)
- •Known active infection other than COVID-19
- •Pregnancy or Breastfeeding
- •Other protocol defined exclusion criteria may apply
研究组 & 干预措施
M5049 50 mg
干预措施: M5049 (Drug)
M5049 100 mg
干预措施: M5049 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Recovery
时间窗: Day 1 through Day 28
Time to recovery was defined as the time from first dose (Day 1) to first occurrence of World Health Organization (WHO) 9-point ordinal scale 3 or less. The scoring is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or Extracorporeal membrane oxygenation (ECMO); 8. Death.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious TEAEs (SAEs) According to NCI-CTCAE Version 5.0
时间窗: Day 1 through Day 60
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs.
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
时间窗: Day 1 through Day 28
Laboratory investigation included hematology and biochemistry. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Measurements
时间窗: Day 1 through Day 28
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
次要结局
- Time to Intensive Care Unit (ICU) Admission(Day 1 through Day 28)
- Time to Non-Invasive Mechanical Ventilation(Day 1 through Day 28)
- Time to Invasive Mechanical Ventilation(Day 1 through Day 28)
- Total Length of Stay in Intensive Care Unit (ICU)(Day 1 through Day 60)
- Percentage of Participants Alive and Not Requiring Supplemental Oxygenation(Day 3, Day 7, Day 14, Day 21 and Day 28)
- Number of Participants in Each Clinical Status Category Based on 9-Point Ordinal Scale(Baseline, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 14, Day 21, Day 28, Day 44, Day 60)
- Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours in Room Air(Day 1 through Day 28)
- Percentage of Participants With All-Cause Mortality(Day 1 through Day 60)
- Total Length of Hospitalization Stay(Day 1 through Day 60)
- Time to Hospital Discharge(Day 1 through Day 60)
- Percent Change From Baseline in Inflammatory Biomarkers Over Time(Baseline, Day 3, Day7, Day 10, Day 14 and Day 28)
- Percent Change From Baseline in Serum Cytokine Biomarkers(Baseline, Day 3, Day7, Day 14 and Day 28)
- Percentage of Participants With Relapse(Day 5 through Day 60)
- Percentage of Participants Who Are Re-Hospitalized(Day 5 through Day 60)