NCT04676971已完成2 期
Efficacy and Safety of Intravenously Administered hzVSF-v13 in Patients With COVID-19 Pneumonia: a Phase II, Proof of Concept, Multicentre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study
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
- 115
- 试验地点
- 9
- 主要终点
- Clinical failure at Day 28
研究概览
简要总结
Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.
详细描述
Proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled
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
- •Signed written informed consent from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative. Note: In accordance with the European Medicines Agency (EMA) "Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic version 3 28/04/2020", if written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent may be given orally by the trial participant in the presence of an impartial witness.
- •Age 18 years or older.
- •Patient is currently hospitalized.
- •Diagnosis of COVID-19 pneumonia including a positive RT-PCR test for SARS-CoV-2 of any specimen and lung involvement confirmed with chest imaging (X-ray or computed tomography [CT] scan).
- •Able to comply with the study protocol.
- •Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception throughout the study and for up to 120 days after stopping treatment. Effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide.
排除标准
- •Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
- •Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- •Anti-rejection or immunomodulatory drugs within the past 3 months.
- •Absolute neutrophil count (ANC) < 1000/µL at screening.
- •Platelet count < 50,000/ µL at screening.
- •ALT or AST > 5 x upper limit of normal (ULN) within 24 hours at screening.
- •Serum creatinine > 2 mg/dL (> 176.8 μmol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.
- •Pregnancy or breastfeeding.
- •Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational COVID-19 antivirals and other off-label drugs recommended by local health authorities are permitted).
- •Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).
研究组 & 干预措施
100 mg hzVSF-v13 IV + SOC
Experimental
100 mg hzVSF-v13 IV + SOC
干预措施: hzVSF-v13 (Drug)
200 mg hzVSF-v13 IV + SOC
Experimental
200 mg hzVSF-v13 IV + SOC
干预措施: hzVSF-v13 (Drug)
Placebo (saline) IV + SOC
Placebo Comparator
Placebo (saline) IV + SOC
干预措施: Placebo (Normal saline solution) (Drug)
结局指标
主要结局
Clinical failure at Day 28
时间窗: Day 28
A patient will be considered a clinical failure if on Day 28 the patient is dead, intubated and/or in ICU.
次要结局
- Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale(Day 28)
- Rate of overall survival (OS) at Day 28 and Day 60(Day 28, Day 60)
- Incidence and severity of adverse events according to NCI CTCAE v5.0(Day 60)
研究者
研究点 (9)
Loading locations...
相似试验
终止
1 期
Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic DermatitisAtopic DermatitisNCT03846466Kyowa Kirin Co., Ltd.5
Unknown
不适用
Safety and Clinical Effectiveness of A3 SVF in OsteoarthritisOsteoarthritisNCT01947348Institute of Regenerative and Cellular Medicine30
已完成
3 期
FS VH S/D 500 S-apr in Vascular SurgeryHemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft ProsthesesNCT00892957Baxter Healthcare Corporation176
已完成
2 期
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive SleepinessExcessive SomnolenceNCT00467441Vanda Pharmaceuticals60
已完成
3 期
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type PsoriasisPlaque-type PsoriasisNCT01412944Novartis Pharmaceuticals43