ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to improvement on a 7-point ordinal scale as compared to baseline
研究概览
简要总结
This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection.
On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-90
- •Confirmed laboratory COVID-19 infection by RT-PCR
- •Meeting severe or critical criteria of COVID-19 infection as defined at treating hospital
- •Confirmed pneumonia by chest radiograph or computed tomography
- •Fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
- •Oxygen saturation less than 92%
排除标准
- •Recent use of illicit drugs or alcohol abuse
- •Known allergy to tradipitant or other neurokinin-1 antagonists
- •Pregnancy
- •Known HIV, HBV, or HCV infection
- •Malignant tumor, other serious systemic diseases
- •Inability to provide informed consent or to have an authorized relative or designated person provide informed consent, or to comply with the protocol requirements
研究组 & 干预措施
Tradipitant
Tradipitant 85 mg PO BID
干预措施: Tradipitant (Drug)
Placebo
2 capsules of matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to improvement on a 7-point ordinal scale as compared to baseline
时间窗: 14 days or discharge
次要结局
- Reduction from baseline of NRS for cough(14 days or discharge)
- Time to normalization of fever for at least 48 hours(14 days or discharge)
- Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus(14 days or discharge)
- Reduction from baseline of NRS for nausea(14 days or discharge)
- Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)(14 days or discharge)
- Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples(14 days or discharge)
- In-hospital mortality(14 days or discharge)
- Mean change in NEWS2 score from baseline(14 days or discharge)
- Time to improvement in oxygenation for at least 48 hours(14 days or discharge)