NCT07482657招募中2 期
Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zelicapavir in Participants ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Time to complete resolution of clinical signs of RSV as measured by RESOLVE-P
研究概览
简要总结
Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 28 Days 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2 or influenza
- •Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization
- •In the Investigator's opinion, the participant's caregiver understands and is able to comply with protocol requirements, instructions, and restrictions, and the participant is likely to complete the study as planned. The caregiver(s) should be of legal age.
排除标准
- •Participant has any condition that in the opinion of the Investigator would interfere with the evaluation of the study drug or participant safety.
- •Participant has underlying immune deficiency. Participants with immunoglobulin A deficiency are not excluded.
- •Participant has had major surgery within 6 weeks prior to randomization or has major surgery planned during the course of the study.
- •Participant is currently taking either chronically or has taken within 7 days prior to randomization, or is anticipated to receive during the course of the study, systemic medications that are known to cause immunosuppression other than corticosteroids for >5 days.
- •Participant has received an investigational agent within the last 30 days or 5 half-lives of the investigational agent, whichever is longer.
研究组 & 干预措施
zelicapavir
Experimental
zelicapavir, oral suspension, once daily for 7 days
干预措施: zelicapavir (Drug)
Placebo
Placebo Comparator
Matching placebo, orally, once daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time to complete resolution of clinical signs of RSV as measured by RESOLVE-P
时间窗: Day 1 through Day 14
次要结局
- Time to sustained resolution of clinical signs of RSV as measured by RESOLVE-P(Day 1 through Day 14)
- Change in severity of clinical signs of RSV from Baseline to D7 as measured by RESOLVE-P(Day 1 through Day 7)
- Proportion of participants with Lower Respiratory Tract Infection (LRTI)(D1 through D14)
- Change in severity of RSV from Baseline to D7 and D14(Baseline to D7 and D14)
- Proportion of outpatient participants who were hospitalized due to RSV or other causes during the study period(Day 1 through Day 35)
- Change in RSV viral load as measured by RT-qPCR(Baseline to D7)
- Proportion of participants with viral load Target Not Detected (TND)(Day 4, Day 7 and Day 14)
- Time to viral load TND(Day 1 through Day 14)
- Plasma PK Concentrations of zelicapavir(Up to Day 7)
- Safety as measured by frequency of adverse events (AEs)(Up to Day 35)
研究者
研究点 (8)
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