NCT05172141终止1 期
A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Number of treatment related AEs
研究概览
简要总结
This is a Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314.
详细描述
Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 24 health volunteers. This phase of the study is designed to assess the safety, tolerability and PK of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 198 mild to moderate adult patients with COVID-19. This phase of the study is designed to assess the efficacy, safety, PK and PD of IBI314.
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)
盲法说明
Masking participant and 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
- 是
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 6 months 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
- •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, 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
Number of treatment related AEs
时间窗: 29 days after the last participant is randomized
Any AEs and SAEs occurring during the study
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
次要结局
- maximum concentration (Cmax)(29 days after the last participant is randomized)
- volume of distribution (V)(29 days after the last participant is randomized)
- area under the concentration-time curve (AUC)(29 days after the last participant is randomized)
- half-life (t1/2)(29 days after the last participant is randomized)
- Change from baseline in viral shedding on Day 7, 11, 22(7, 11, 22 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.(22 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)
- Proportion of patients who become severe COVID-19 by Day 29(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)
- Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29(3, 7, 15, 22, 29 days after the last participant is randomized)
- clearance (CL)(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)
- Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR(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(11 days after the last participant is randomized)
- Proportion of patients requiring mechanical ventilation by day 29(29 days after the last participant is randomized)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19COVID-19NCT05162365Innovent Biologics (Suzhou) Co. Ltd.248
招募中
2 期
IBI343 Combined With Chemotherapy in Advanced Pancreatic CancerAdvanced Pancreatic CancersNCT06770439Zhejiang University64
终止
1 期
A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid TumorMyeloid TumorNCT05148442Innovent Biologics (Suzhou) Co. Ltd.1
招募中
1 期
Study of IBI363 in Patients with Advanced First-line Gastric CancerIBI363 + ChemotherapyNCT06610799Xiangdong Cheng40
终止
1 期
A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular CarcinomaHepatocellular CarcinomaNCT04635527Innovent Biologics (Suzhou) Co. Ltd.10