NCT04708158Unknown3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon vs. Placebo in Hospitalized Adult Patients With ModerateCOVID-19
适应症
试验速览
- 阶段
- 3 期
- 发起方
- Genova Inc.
- 入组人数
- 385
- 试验地点
- 22
- 主要终点
- Time to clinical improvement
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
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)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been obtained from the participants with age of over 20 years at the time of signing the informed consent.
- •SARS-CoV-2 infection is diagnosed by the positive SARS-CoV-2 detection of RT-PCR tests within 72 hours before the start of administration of the investigational drug
- •Less than 6 days from onset of COVID-19 symptoms to starting the administration of the investigational drug. The symptoms are defined as one or more of the following: fever (37.5 ºC or higher), respiratory symptoms (cough, shortness of breath, chest pain, sore throat, running nose, nasal congestion, etc.), headache, malaise, abdominal pain, diarrhea, nausea, vomiting, loss of smell, loss of taste, or other COVID-19 symptoms defined by investigators or physicians.
- •Have at least one of the following findings.
- •Oxygen saturation (SpO2) measured by pulse oximeter is less than 96% and more than 93%.
- •Chest X-ray or CT scan shows pneumonia findings suggestive of COVID-19 infection
- •Need hospitalization and COVID-19-related medical care.
- •Require no supplemental oxygen.
- •Women (less than 12 months after the last menstrual period) who have a negative pregnancy test (urine hCG qualification) and agree to take oral contraceptives or use condom during study period.
排除标准
- •History of hypersensitivity to interferon or Novaferon or any excipients of interferon or Novaferon.
- •Having received other antiviral treatments (Favipiravir, Remdesivir, Interferon, etc.).
- •CTCAE Grade 3 or higher liver dysfunction (ALT / AST> 5ULN) or renal dysfunction (eGFR <30 mL / min / 1.73 m2).
- •Active infections or other medical conditions that contraindicate inhalation therapy.
- •Inappropriate for inclusion in the clinical trial as determined by investigators.
结局指标
主要结局
Time to clinical improvement
时间窗: From enrollment up to Day 28
Time to patient clinical improvement by 2 points on a 7-point ordinal scale
次要结局
- Rate of clinical deterioration(Day 1 to Day 10, 14 and 28)
- Mortality rate(At Day 28)
- Duration of hospital stay(From enrollment up to Day 28)
- Adverse events(From enrollment up to Day 28)
- Time to viral clearance(From enrollment up to Day 28)
- Rate of alive patients(At Day 28)
- Rate of clinical improvement(Day 1 to Day 10, 14 and 28)
- Rate of viral clearance(Each Day from Day 1 up to Day 28)
- Change in viral load(Each Day from Day 1 up to Day 28)
- Time to resolution of symptoms(From enrollment up to Day 28)
- Requirement of supplemental oxygen(From enrollment up to Day 28)
- Requirement of mechanical ventilation(From enrollment up to Day 28)
研究者
研究点 (22)
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