NCT03808922招募中3 期
A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 274
- 试验地点
- 89
- 主要终点
- Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
研究概览
简要总结
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection.
It also contains a sub-study to enroll patients with severe COVID-19.
详细描述
Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled in one of four cohorts based on the following criteria:
Cohort 1:
All eligible subjects in the PoI who are ≥18 year old subjects with a PIV infection and meet all of the following criteria:
1.1 Meet criteria for being severely immunocompromised 1.2 Prior to the onset of PIV infection, had no ongoing need for oxygen therapy due to a chronic respiratory condition (e.g., COPD, sleep apnea) and are assessed as acutely hypoxemic due to their PIV infection 1.3 At the time of randomization are not on mechanical, bi-level or continuous positive airway pressure (Bi-PAP or CPAP) ventilation 1.4 Have no known concurrent respiratory viral coinfection(s)
Cohort 2:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
- •Immunocompromised, as defined by one or more of the following:
- •Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past
- •Received a solid organ transplant at any time in the past
- •Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past
- •Has an immunodeficiency due to congenital abnormality (only applicable to subjects age < 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)
- •Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
- •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
- •For COVID-19 sub study:
- •Be ≥18 years of age
- •Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
- •Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
- •Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
- •Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
- •Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
排除标准
- •Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
- •Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for >1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded
- •Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
- •Subjects taking any other investigational drug used to treat pulmonary infection.
- •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
- •Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria:
- •Has evidence of vital organ failure outside of the lung (e.g., liver, kidney)
- •Requires vasopressors to maintain blood pressure
- •For COVID-19 sub study:
- •Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
- •Subjects receiving any other investigational or empiric treatment for SARS-2-CoV (either as part of a clinical trial or under emergency approval (approved agents for the management of symptoms, e.g., fever, are permitted).
- •Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
- •Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
- •Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria:
- •Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)
- •Require vasopressors to maintain blood pressure
- •Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study
研究组 & 干预措施
Cohort 1 and Cohort 2 Placebo
Placebo Comparator
Placebo qd x 7 OR 10 days
干预措施: Placebo (Drug)
Cohort 3
Experimental
DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)
干预措施: DAS181 OL (Drug)
Cohort 4
Experimental
DAS181 4.5mg qd x 7 OR 10 days
干预措施: DAS181 OL (Drug)
DAS181 COVID-19 Treatment
Experimental
DAS181 4.5mg q12h x 7 OR 10 days
干预措施: DAS181 COVID-19 (Drug)
DAS181 COVID-19 Placebo
Placebo Comparator
Placebo q12h x 7 OR 10 days
干预措施: Placebo (Drug)
Cohort 1 and Cohort 2 Treatment
Experimental
DAS181 4.5mg qd x 7 OR 10 days
干预措施: DAS181 (Drug)
结局指标
主要结局
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
时间窗: Day 14
Percent of subjects who Return to Room Air (RTRA) (main study)
时间窗: by Day 28
Removal of all oxygen support (with stable SpO2)
次要结局
- Baseline SAD-RV infection-related mortality rate (main study)(at Day 35)
- Percent of subjects who Return to Room Air (RTRA) (main study)(by Day 21)
- Percent of subjects who achieve clinical stability (main study)(by Day 28)
- Percent of subjects discharged (without mortality and hospice) (main study)(by Days 14, 21, 28 and 35)
- Time (in days) to first hospital discharge (without hospice) (main study)(through Day 35)
- All-cause mortality rate (main study)(at Day 35)
- Time to Clinical stability(Day 14, Day 21, Day 28)
- Time (in days) to RTRA (main study)(Days 10, 14, 21, 28)
- Total number of inpatient days (main study)(up to Day 35)
- Time to RTRA(Day 10, Day 14, Day 21, Day 28)
- Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable(Day 5, Day 10, Day 14, Day 21, Day 28)
- Time to Discharge from hospital (without readmission before Day 28).(Day 14, Day 21, Day 28)
- Time to Death (all causes)(Day 14, Day 21, Day 28)
- Change in pulmonary function (FEV1% predicted) (main study)(Day 1, Day 7, Day 14, Day 28)
- Time to improved COVID19 clinical status (Sub-study)(Day 5, Day 10, Day 21, Day 28)
- Time to Clinical deterioration(Day 5, Day 10, Day 14, Day 21, Day 28)
研究者
研究点 (89)
Loading locations...
相似试验
已完成
2 期
Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed InfluenzaInfluenzaNCT01037205Ansun Biopharma, Inc.264
已完成
3 期
LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based ChemotherapyHead and Neck NeoplasmsNCT01856478Boehringer Ingelheim340
招募中
3 期
A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy PeoplePneumococcal DiseaseNCT06044077Aimei Vacin BioPharm (Zhejiang) Co., Ltd.1,920
已完成
2 期
Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired InfluenzaInfluenzaNCT01740063Ansun Biopharma, Inc.423
已完成
3 期
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus VaccineHealthy VolunteersNCT03525119Takeda900