NCT04679415已完成2 期
A Multi Center, Randomized, Double-blind, Parallel Design, Phase 2 Study to Evaluate the Efficacy and Safety of hzVSFv13 Compared to Standard of Care After Intravenous (IV) Administration With Add-on Standard of Care in COVID-19 Moderate to Severe Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Clinical failure rate at Day 28
研究概览
简要总结
Explore the efficacy and confirm the safety of the concomitant administration of the standard of care and hzVSF-v13 in patients with COVID-19 infection
详细描述
Multi center, Randomized, Double-blind, Parallel group, Phase 2 clinical study
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)
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
- •Adults aged at least 18 years at screening
- •Those who have been admitted or scheduled to be admitted due to a diagnosis with moderate to severe COVID-19 by RT-PCR test within 4 days prior to screening
- •Patients whose findings of COVID-19 pneumonia have been confirmed by radiographic tests (CT and X-ray) at screening (e.g., ground glass opacity (GGO), crazy-paving pattern, or consolidation)
- •Those who fall under the following at screening:
- •Patients identified as moderate Oxygen saturation in the atmosphere (SpO2) ≥ 93% (respiratory rate ≥20/min or pulse rate ≥90 beats/min secondarily)
- •Patients identified as severe Oxygen saturation in the atmosphere (SpO2) < 93% with (respiratory rate ≥30/min or pulse rate ≥125 beats/min secondarily)
- •Those who have voluntarily provided a written consent to participate in this clinical study
排除标准
- •Individuals with a clinically significant history of hypersensitivity reactions to the components of hzVSF-v13, drugs containing components of the same class, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
- •Patients with pneumonia other than due to the novel coronavirus (SARS-CoV-2) infection (e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia)
- •Patients with severe heart failure (NYHA Class III or higher)
- •Pregnant women
- •Men and women of childbearing potential who are planning to become pregnant or do not agree to use one or more of the clinically appropriate methods of contraception below from the first day until 120 days after the last day of investigational product administration Surgical infertility (e.g., bilateral tubal ligation, vasectomy) Hormonal contraceptives (implantable form, patch, oral administration) Double-barrier method (concomitant use of two of the following: IUD, male or female condom used with spermicide, contraceptive diaphragm, contraceptive sponge, cervical cap)
- •Periodic abstinence (e.g., calendar, ovulation date, basal body temperature, post-ovulation methods) and coitus interruptus are not permitted as appropriate contraceptive methods,and effective contraceptive methods must be kept being used during the course of the clinical study.
- •Those who are scheduled to have organ transplantation
- •Those who have laboratory test results that fall under the following values at screening ALT or AST ≥5 times the upper limit of normal (ULN) eGFR < 30 mL/min/1.73m2 platelets < 50,000/mm3
- •Those who have a positive result for serology (hepatitis B, human immunodeficiency virus [HIV], and hepatitis C tests) at screening
- •Those who received other investigational products within 30 days prior to the screening visit
- •Others who have been determined to be ineligible to participate in the clinical study according to the investigator's medical opinion, or subject who will/planned to be transferred to other hospital within study period
研究组 & 干预措施
Standard of care + hzVSF-v13 200 mg at D1, hzVSF-v13 100mg at D3 and D7 IV
Experimental
Drug: hzVSF-v13 Dosage form: hzVSF-v13 40mg/mL in a 5mL vial Frequency: Dose at Day 1, 3, 7 Other names: a humanized monoclonal antibody (mAb)
干预措施: hzVSF-v13 (Drug)
Standard of care + hzVSF-v13 400 mg at D1, hzVSF-v13 200mg at D3 and D7 IV
Experimental
Drug: hzVSF-v13 Dosage form: hzVSF-v13 40mg/mL in a 5mL vial Frequency: Dose at Day 1, 3, 7 Other names: a humanized monoclonal antibody (mAb)
干预措施: hzVSF-v13 (Drug)
Standard of care + 3 doses of the placebo (normal saline) IV
Placebo Comparator
Drug: Placebo (Normal saline solution) Dosage form: 0.9% NaCl Solution Frequency Frequency: Dose at Day 1, 3, 7 Other names: 0.9% Normal saline
干预措施: Placebo (Normal saline solution) (Drug)
结局指标
主要结局
Clinical failure rate at Day 28
时间窗: Day 28
The clinical failure rate is defined at Day 28 if patient reported any of * Death * Respiratory failure (patient is intubated) * Patient is in the Intensive Care Unit (ICU)
次要结局
- Changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28(Day 7, Day 14, Day 28)
- Time to recovery* after investigational product administration (days)(Day 28)
- Time to Clinical Improvement from randomization to clinical improvement (2 points decreased from the baseline score) (days)(Day 28)
- Changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28(Day 7, Day 14, Day 21, and Day 28)
- Time to discontinuation of oxygen therapy after investigational product administration(Day 28)
- Changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28(Day 7, Day 14, Day 21, Day 28)
研究者
研究点 (3)
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