A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID-19 (EVADE)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2,582
- 试验地点
- 2
- 主要终点
- Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)
研究概览
简要总结
This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.
详细描述
Phase 2/3, multicenter, double-blind, placebo-controlled, randomized study of the mAb ADG20 in the prevention of symptomatic COVID-19 in adults and adolescents with no known history of SARS-CoV-2 infection but whose circumstances place them at increased risk of acquiring SARS-CoV-2 infection and developing symptomatic COVID-19. This objective was independently evaluated in a cohort of participants with reported recent exposure to an individual diagnosed with a SARS-CoV-2 infection (post-exposure prophylaxis) and in a cohort of participants with no reported exposure to SARS-CoV-2 (pre-exposure prophylaxis). These cohorts included participants whose advanced age (≥55 years old) or health status placed them at risk for severe COVID-19 or COVID-19 complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 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
- •Tests negative for current or previous SARS-CoV-2 infection by RT-PCR and serology (Pre-exposure population only)
- •Is at high risk of SARS-CoV-2 infection as assessed by the Investigator:
- •Post-exposure population: exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). Note: Participants with recent exposure to a laboratory-confirmed index case must be asymptomatic and randomized within 5 days (120 hours) of collection of the index case's positive SARS-CoV-2 diagnostic test.
- •Pre-exposure population: Occupational, housing, recreational and/or social conditions that are likely to increase risk of exposure to SARS-CoV-
- •Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months) after dosing
排除标准
- •Has received (1) a SARS-CoV-2 vaccine, (2) mAb or (3) convalescent plasma from a person who has recovered from COVID-19 or prior participation in SARS-CoV2 vaccine, convalescent plasma, or mAb clinical trial any time prior to participation in the study.
- •Receipt of any investigational product within 30 days or 5 half lives before the day of enrollment.
- •Is acutely ill or febrile 72 hours before or at Screening or has other COVID-19 symptoms including cough, fatigue, muscle or body aches, headache, or loss of taste or smell. Fever is defined as a body temperature ≥38.0°C (≥100.4°F).
- •Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after dosing (except for seasonal influenza vaccine, which is not permitted within 14 days before or after dosing).
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
ADG20
Participants will be dosed on Day 1 with ADG20 IM
干预措施: ADG20 (Drug)
Placebo
Participants will be dosed on Day 1 with placebo IM
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)
时间窗: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
时间窗: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.
Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)
时间窗: Day 1 through 14 Months or 25Jul2022, whichever is earlier
Any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment; includes solicited injection site reactions
Solicited Injection Site Reactions (PEP, PrEP)
时间窗: Day 1 through Day 4
Percentage of participants with at least one solicited injection site reaction
次要结局
- Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP)(Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)(Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP)(Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With a COVID-19 Related Hospitalization (PEP)(Through 28 Days from COVID-19-like illness initial visit (CLI Day 1))
- Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP)(Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)(Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)(Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP)(Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP)(Day 1 through 6 Months or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP)(Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier)
- COVID-19 Related Mortality (PrEP)(Through 28 Days from COVID-19-like illness initial visit (CLI Day 1))
- All-Cause Mortality (PEP)(Through 28 Days from COVID-19-like illness initial visit (CLI Day 1))
- All-Cause Mortality (PrEP)(Through 28 Days from COVID-19-like illness initial visit (CLI Day 1))
- Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)(Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier)
- SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)(Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)(Through 28 days from COVID-19-like illness initial visit (CLI Day 1))
- COVID-19 Related Mortality (PEP)(Through 28 Days from COVID-19-like illness initial visit (CLI Day 1))
- Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PEP)(Positive CLI Day 1 sample through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP)(Positive CLI Day 1 sample through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier)
- Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP)(Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier)
- Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)(An average of 2 months up to 7 months through cutoff date prior to emergence of Omicron (15-Dec-2021))
- Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)(An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021))