A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 399
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent Adverse Events
研究概览
简要总结
This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.
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)
盲法说明
The investigator, participant and sponsor personnel involved in study intervention and study evaluation will be unaware of the intervention assignments. Investigators will remain blinded to each participant's assigned study treatment throughout the course of the study.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
- •Has had symptoms consistent with COVID-19 with onset 5 days before randomization
- •Has one or more COVID-19-related signs or symptoms on the day of randomization
- •Phase 2: Is an adult aged 18 years and above
- •Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening
排除标准
- •Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization.
- •Has severe COVID-19 or is on supplemental oxygen
- •Has a history of a positive SARS-CoV-2 antibody serology test
- •Has participated, within the last 30 days, in a clinical study involving an investigational intervention
- •Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID-19 any time prior to participation in the study
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
ADG20 IM
Participants will be dosed on Day 1 with ADG20 IM
干预措施: ADG20 (Drug)
Placebo IM
Participants will be dosed on Day 1 with placebo IM
干预措施: Normal saline (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events
时间窗: Through day 29
Proportion of participants with at least one treatment emergent AE
Incidence of Solicited Injection Site Reactions
时间窗: Through Day 4
Proportion of participants with at least one solicited injection site reaction
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
时间窗: Through Day 29
Proportion of participants with a potentially clinically significant change from baseline in post-baseline laboratory parameters - data presented for any analyte with \>/= 2% in any arm
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
时间窗: Through Day 29
Participants with Potentially Clinically Significant Changes (PCS) From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure) at Any Time Post-Baseline
Incidence of COVID-19 Related Hospitalizations or All-cause Death
时间窗: Through Day 29
To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID-19 in participants at high risk of disease progression. Hospitalization is defined as ≥24 hours of acute care in a hospital or acute care facility (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities). All-cause death is defined as death for any reason from Day 1 (postdose) through Day 29.
次要结局
- Incidence of COVID-19 -Related Emergency Room Visits, COVID-19-related Hospitalization, or All Cause-death(Through Day 29)
- Incidence of All-cause Mortality(Through Day 90)
- Viral Load >5 (log10 Copies/mL) Based on Nasopharyngeal Sampling at Day 7(on Day 7 (+/- 1 Day))
- Incidence of Treatment Emergent Adverse Events(14 months)
- Incidence of COVID-19 -Related Medically Attended Visits or All-cause Death(Through Day 29)
- Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL) to Day 7 (±1)(Day 7 (±1))
- Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)(14 Months)
- Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)(14 Months)
- Time to Sustained Resolution of COVID-19 Symptoms as Measured in the Daily COVID-19 Symptom Diary(Through Day 29)
- Time to Sustained Recovery Defined as Sustained Improvement or Resolution of COVID-19 Symptoms(Through Day 29)
- Duration of SARS-CoV-2 Shedding Assessed by RT-qPCR From Saliva Samples(Through Day 29)
- SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7)(Days 5, 7, 11, 14, 21, and 29 (saliva))
- Incidence of Severe/Critical COVID-19 or All Cause Death(Through Day 29)
- SARS-CoV-2 Viral Load AUC Assessed by RT-qPCR From Saliva Samples(Baseline to Day 29)
- Incidence of ADA to ADG20(11 months)
- Genotypic Characterization of Viral Isolates for Reduced Susceptibility to ADG20 (G504 Mutations)(Through Day 29)