NCT05162365终止1 期
A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 248
- 试验地点
- 38
- 主要终点
- Virologic efficacy Evaluation
研究概览
简要总结
This is a dose-finding, inferentially seamless Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314 in Ambulatory Patients with COVID-19.
详细描述
Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 32 ambulatory adult patients with COVID-19. This phase of the study is designed to assess the safety, tolerability, PK, and PD of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 208 ambulatory adult patients with COVID-19. This phase of the study is designed to assess the efficacy and safety of IBI314, administered by single IV infusion at dose levels that meet none of the termination criteria for dose escalation in Phase 1 of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •First onset of COVID-19 symptoms <7 days at randomization, symptoms such as fever and/or chills, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.
- •Have a positive SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test using an appropriate sample such as nasopharyngeal (NP), nasal, oropharyngeal, or saliva within 72 hours prior to randomization. A historical record of a positive result from a test conducted ≤72 hours prior to randomization is acceptable.
- •Male or female patients ≥18 years of age at the time of signing informed consent.
- •Agree to use an adequate method of contraception throughout the study period and for 90 days after the dose of study drug is administered.
- •Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test at screening.
排除标准
- •according to protocol v3.0, Note: Patients with mild-to-moderate disease who are placed in a facility where required by local guidelines can be enrolled.
- •Have oxygen saturation (SpO2) ≤93 % on room air at sea level or a ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute.
- •Have evidence of multi-organ dysfunction/failure.
- •Systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg, or requiring vasopressors.
- •Require or anticipated impending need for endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
结局指标
主要结局
Virologic efficacy Evaluation
时间窗: 7 days after the last participant is randomized
Time-weighted average change in viral shedding from baseline through Day 7 as measured by RT-qPCR in NP swab samples.
Number of treatment related AEs
时间窗: 29 days after the last participant is randomized
Any AEs and SAEs occurring during the study
次要结局
- half-life (t1/2)(29 days after the last participant is randomized)
- maximum concentration (Cmax)(29 days after the last participant is randomized)
- volume of distribution (V)(29 days after the last participant is randomized)
- Time to alleviation of symptoms (going to mild or absent)(29 days after the last participant is randomized)
- Change from baseline in viral shedding on Day 7, 11, 22(29 days after the last participant is randomized)
- area under the concentration-time curve (AUC)(29 days after the last participant is randomized)
- Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR(29 days after the last participant is randomized)
- Proportion of patients with at least one COVID-19 related medically attended visits by Day 29(29 days after the last participant is randomized)
- Proportion of patients admitted to a hospital and emergency room visit due to COVID-19 by Day 29(29 days after the last participant is randomized)
- Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.(29 days after the last participant is randomized)
- The incidence of anti-IBI314 antibody (ADA) and neutralizing antibody (NAb) in serum before and after study drug administration(29 days after the last participant is randomized)
- Proportion of patients with all-cause mortality by Day 29(29 days after the last participant is randomized)
- Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples(29 days after the last participant is randomized)
- clearance (CL)(29 days after the last participant is randomized)
研究者
研究点 (38)
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