NCT04346615终止2 期
BHV3500-203: Phase 2/3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of Zavegepant (BHV-3500) Intranasal (IN) for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 47
- 试验地点
- 6
- 主要终点
- Mean 6 Point Ordinal Severity Rating Scale (6POSRS) Score at Day 15
研究概览
简要总结
The purpose of this study is to determine if a CGRP receptor antagonist may potentially blunt the severe inflammatory response at the alveolar level, delaying or reversing the path towards oxygen desaturation, Acute respiratory distress syndrome (ARDS), requirement for supplemental oxygenation, artificial ventilation or death in patients with COVID-19 on supplemental oxygen.
* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.
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
- 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
- •Subjects must provide informed consent in accordance with requirements of the study center's institutional review board (IRB) or eithics committee prior to the initiation of any protocol-required procedures
- •Subjects must agree to provide all requested demographic information (i.e. gender, race)
- •Subjects must be able to read and understand English or Spanish
- •Subjects must be over the age of 18 years
- •Subjects must have laboratory-confirmed SARS-CoV-2 infection as determined by PCR-based commercial or public health assay
- •Subjects must have symptoms that require hospitalization with supplemental oxygen and / or non-invasive ventilation as determined by the admitting physician. The maximum nasal cannula O2 concentration should be determined by the treating clinician and the limitations of the specific equipment
- •Subjects must be willing and able to comply with study-related procedures/assessments
排除标准
- •Subjects in immediate need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- •Subjects with an eGFR < 30 mL/min, at the Screening Visit
- •Prisoners or subjects who are involuntarily incarcerated
- •Subjects who are participating in any other investigational clinical trial while participating in this clinical trial
- •Subjects who are under the age of 18 years
- •Subjects who are pregnant (all potential female enrollees need to have a negative pregnancy test prior to IP administration)
- •Subjects with multi-organ failure
- •Subjects who have received more than 48 hours of supplemental oxygen prior to randomization
- •Subjects with prior significant pulmonary disease (e.g., severe COPD/ILD/CHF/IPF) are excluded
- •Subjects receiving investigational therapies as part of a formal clinical trial for the treatment of COVID-
- •During the course of this study, investigational therapies that may become "standard of care" to treat COVID-19, but are not part of a clinical trial, are allowed
- •Subjects who are on long-acting CGRP monoclonal antibodies will be excluded including Aimovig (erenumab), Emgality (galcanezumab), Ajovy (fremanezumab), and Vyepti (eptinezumab). Additionally, the investigational oral CGRP receptor antagonist, atogepant, that is taken daily will also be excluded. Oral CGRP receptor antagonists, Nurtec ODT (rimegepant) and Ubelvy (ubrogepant) that are typically used PRN infrequently will not be excluded as long the subject was not taking them on a daily basis and does not take them during the current study
- •Subjects who are unlikely to survive for more than 48 hours from the Screening Visit
- •Subjects with any of the following abnormal laboratory values at screening: aspartate AST or ALT greater than 5x ULN or bilirubin greater than 2x ULN
- •Subjects with known active TB, history of incompletely treated TB, suspected or known extrapulmonary TB
- •Subjects with suspected or known systemic bacterial or fungal infections. However, empiric antibiotics are permitted.
- •Subjects who have participated in any clinical research study evaluating an IP or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit
- •Subjects with any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study
研究组 & 干预措施
Zavegepant
Experimental
Zavegepant (BHV-3500) 10 mg intranasal (IN) dosed every 8 hours (3 times/day) (Q8h) for 14 days
干预措施: Zavegepant (BHV-3500) (Drug)
Placebo
Placebo Comparator
Placebo Q8h for 14 days
Subjects dosed every 8 hours; 3 times/day (Q8h)
干预措施: Placebo (Drug)
结局指标
主要结局
Mean 6 Point Ordinal Severity Rating Scale (6POSRS) Score at Day 15
时间窗: Day 15
The 6POSRS score was used to assess severity and ranged from 1 to 6 where: 1= Death; 2= Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 3= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, not requiring supplemental oxygen and 6= not hospitalized. A higher score indicated a better outcome.
次要结局
- Percentage of Participants Admitted Into an Intensive Care Unit (ICU) Through Day 29(Up to Day 29)
- Percentage of Participants With a 6-Point Severity Rating of 5 or 6, Who Were Alive and Off Supplemental Oxygen at Day 29(Day 29)
- Percentage of Participants With a 6-Point Severity Rating of 2 or 3 or Required Initiation of Invasive Mechanical Ventilation, Non-Invasive Ventilation, or a High-Flow Nasal Cannula Through Day 29(Up to Day 29)
- Number of Participants With Severe or Life-Threatening Bacterial, Invasive Fungal, or Opportunistic Infections Through Day 29(Up to Day 29)
- Number of Participants With Intranasal Administration Reactions Through Day 29(Up to Day 29)
- Percentage of Participants With >= 50% Reduction in Estimated Glomerular Filtration Rate (eGFR) From Baseline(From Baseline (Day 1) up to Day 15)
- Number of Participants With On-Treatment Deaths, Serious Adverse Events (SAEs) and Severe Adverse Events (AEs)(From first dose of study treatment on Day 1 until Day 15)
- Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities(From first dose of study treatment on Day 1 until Day 15)
研究者
研究点 (6)
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