NCT04527471已完成2 期
A Single-center, Pilot, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ensifentrine in the Recovery of Hospitalized Patients With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Recovery
研究概览
简要总结
This pilot study is being performed to assess the efficacy and safety of inhaled ensifentrine delivered via pMDI compared with a matching placebo in conjunction with standard of care treatments on recovery in patients hospitalized due to COVID-19 infection.
详细描述
Expploratory endpoint, pilot study, not statistically powered
go to protocol
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form and in this protocol.
- •Patient must be at least 18 years of age and less than or equal to 80 years of age at the time of informed consent.
- •Males are eligible to participate or females of non-childbearing potential or WOCBP who have a negative pregnancy test at screening are eligible to participate. WOCBP and female partners of male participants agree to either abstinence or use at least one primary form of highly effective contraception not including hormonal contraception from the time of screening through Day 60 following the first dose of study medication.
- •Clinical status consistent with 3, 4 or 5 on the Ordinal scale: Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring any supplemental oxygen; Hospitalized, requiring non-invasive ventilation or use of high flow oxygen devices.
- •Admission to hospital AND have a confirmed diagnosis of severe acute respiratory syndrome coronavirus (SARS-COV-2) infection confirmed by polymerase chain reaction (PCR) test AND displays at least one of the following: Respiratory rate > 24 breaths per minute; new cough; new atypical chest pain; new dyspnea; oxygen saturation < 97% at rest; chest x-ray with new changes consistent with COVID-related airspace disease.
- •Capable of complying with all study restrictions and procedures including ability to use the pMDI correctly.
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-19, unless related to an expanded access program as part of Standard of Care at screening or during study.
- •Evidence of multiorgan failure.
- •Requiring mechanical ventilation at screening.
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) at screening.
- •Creatinine clearance < 30 mL/min at screening.
- •Pregnancy or lactation at screening.
- •Allergy or other contraindication or one of ensifentrine.
- •In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •Use of prohibited medications (theophylline, PDE4 inhibitors [e.g. roflumilast, apremilast, crisaborole] within 48 hours of screening or during study)
- •Any other reason that the Investigator considers makes the patient unsuitable to participate.
研究组 & 干预措施
Ensifentrine + Standard of Care
Active Comparator
30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection
干预措施: Ensifentrine Dose 1 (Drug)
Placebo + Standard of Care
Placebo Comparator
15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection
干预措施: Placebo pMDI (Drug)
结局指标
主要结局
Proportion of Patients With Recovery
时间窗: Day 29
Recovery = first day on which subject satisfies one of the following categories: not hospitalized, no limitations of activities; or not hospitalized, limitation of activities, home oxygen requirement, or both.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
A Study to Investigate the Safety and Efficacy of a Novel Furosemide RegimenAcute Decompensated Heart FailureNCT02721511Todd M Koelling, MD
终止
2 期
Phase IIa Clinical Study of N-Rephasin® SAL200Staphylococcus Aureus BacteremiaAnti-Bacterial AgentsNCT03089697Intron Biotechnology, Inc.25
已完成
不适用
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn PatientsBurnsNCT03240718Centre hospitalier de l'Université de Montréal (CHUM)12
已完成
不适用
A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young AdultsHyperhidrosisNCT02633371University of Colorado, Denver10
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of DW340 in Patients With Acute Low Back PainAcute Low Back PainNCT03424707Daewon Pharmaceutical Co., Ltd.45