EUCTR2020-003614-13-IT进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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.
- •2. Age 18 years or older.
- •3. Patient is currently hospitalized.
- •4. 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).
- •5. Able to comply with the study protocol.
- •6. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1. Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
- •2. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- •3. Anti-rejection or immunomodulatory drugs within the past 3 months.
- •4. Absolute neutrophil count (ANC) < 1000/µL at screening.
- •5. Platelet count < 50,000/ µL at screening.
- •6. ALT or AST > 5 x upper limit of normal (ULN) within 24 hours at screening.
- •7. Serum creatinine > 2 mg/dL (> 176.8 µmol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.
- •8. Pregnancy or breastfeeding.
- •9. 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).
- •10. Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).
研究者
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