DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percent of subjects return to room air (RTRA)
研究概览
简要总结
It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract COVID-19 who require supplemental oxygen ≥2 LPM at the time of randomization.
详细描述
The first stage is randomized, double-blind study to confirm the optimal dose of the study. Twenty-two (n=22) subjects with COVID-19 and clinically significant impairment of respiratory function will be enrolled to evaluate the two dosing regimens (4.5mg-q.d or 4.5mg-b.i.d) of DAS181. At the end of Stage 1, the Sponsor will evaluate the dose regimen based on the safety and efficacy assessments of the data. An optimal dose will be selected to proceed to Stage 2.
The second stage is a randomized, placebo-controlled and double-blind study to expand enrollment with an additional eighty-two (n=82) subjects to provide adequate power to potentially demonstrate statistically significant therapeutic efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Be ≥18 years of age
- •Provide adequate medical history to permit accurate stratification by health status
- •Prior to SARS CoV 2 infection, has no chronic or recurring requirement for supplemental oxygen
- •Have lower respiratory tract infection (LRTI) confirmed by imaging
- •Has laboratory-confirmation of the presence of SARS-CoV-2 in the respiratory tract
- •At the time of randomization, requires supplemental oxygen ≥2 LPM for treatment of hypoxia or pulmonary stress as evidenced by at least one of the following:
- •Respiratory rate ≥ 30 breaths/min
- •SpO2 ≤93% at rest
- •PaO2/FiO2≤300 mmHg
- •Showing the progression of lung lesions within 24 to 48h by >50%
- •If female, subject must meet one of the following conditions:
- •Not be of childbearing potential or
- •Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
- •Non-vasectomized males are required to practice effective birth control methods
- •Capable of understanding and complying with procedures as outlined in the protocol
- •Provides signed informed consent prior to the initiation of any screening or study-specific procedures
排除标准
- •At the time of randomization, classified as critical (life-threatening) disease
- •Subjects currently receiving any other investigational drug, as part of a clinical trial or under emergency approval for SARS-CoV-2
- •Subjects who are known asthmatic patients or HIV-positive
- •Subjects who are currently receiving inhaled biologics or anti-viral agents
- •Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection with vital organ failure or required vasopressors to maintain blood pressure
- •Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2xULN
- •Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug.
- •Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
- •Subjects with known hypersensitivity to DAS181 and/or any of its components.
研究组 & 干预措施
DAS181 b.i.d.+ standard local care for COVID-19
4.5 mg DAS181 b.i.d nebulized inhalation for 10 consecutive days + standard local care for COVID-19
干预措施: DAS181 (Drug)
Placebo+ standard local care for COVID-19
nebulized inhalation for 10 consecutive days + standard local care for COVID-19
干预措施: Placebo (Drug)
DAS181 q.d.+ standard local care for COVID-19
4.5 mg placebo q.d. nebulized inhalation for 10 consecutive days + standard local care for COVID-19
干预措施: DAS181 (Drug)
结局指标
主要结局
Percent of subjects return to room air (RTRA)
时间窗: Day 14
次要结局
- Return To Room Air (RTRA)(Day 10, 21, 28)
- Percent of subjects who have recovered(Day 5, 10, 14, 21, 28)
- Percent of subjects discharged(Day 14, 21, 28)
- Clinical Deterioration(Day 28)
- Death (all cause)(Day 28)
- Improved COVID-19 Clinical Classification(Day 28)
- Percent of subjects who achieve clinical stability(Day 28)
- SARS-CoV-2 RNA undetectable(Day 28)