A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) in Subjects With COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 248
- 试验地点
- 17
- 主要终点
- Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19
研究概览
简要总结
An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of Tempol in subjects with COVID-19 infection.
详细描述
Phase 2/3 Adaptive, Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection with a primary endpoint of limiting hospitalization.
As part of the initial phase 2 portion of the study, 50 COVID positive subjects with comorbidities will be enrolled. Eligible subjects positively diagnosed COVID-19 infection will be randomized 1:1 to receive either Tempol or placebo.
An interim analysis by a DSMB will examine safety and markers of systemic inflammation during a Stage 1 interim analysis. Based on the DSMB adjudication, the Phase 3 portion of the trial will begin with a second interim analysis after enrollment of 124 subjects
This protocol will seek to enroll approximately 248 subjects > 18 years of age diagnosed with COVID-19 infection. All subjects will receive standard of care. As standard of care can vary between institution over time for the treatment of COVID-19; Off label medication use, therapies, devices, and interventions used in standard of care practice for COVID-19 is allowed.
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)
盲法说明
Randomized, Double-blind, Placebo-Controlled
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 18 years of age and above with at least one risk factor for disease progression (i.e., age≥ 65, hypertension, diabetes, obesity (BMI ≥30 as defined by CDC), cancer, immunodeficiency and in the opinion of the investigator the risk factor is not acutely life-threatening).
- •Laboratory confirmed infection of SARS-CoV-2 within 5 days of Baseline/day
- •Subjects must meet the severity score of Moderate or greater for two of the first ten symptoms listed in the Patient Reported Outcomes (PRO) at screening.
- •Ability to travel to clinic.
- •Ability to understand and sign an informed consent form.
- •Female subjects of child-bearing potential who are capable of conception must be: post- menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ≥18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period.
- •Ability to swallow a capsule.
- •Ability to complete an electronic diary via smartphone or web.
排除标准
- •Need for hospitalization based on severe or critical symptoms based on CDC guidance.
- •Subject in long-term care facility.
- •Known hypersensitivity or contra-indication to Tempol.
- •Subjects taking STRONG CYP inhibitors (e.g. fluoxetine, itraconazole, quinidine, clarithromycin).
- •In the opinion of the investigator, any reason that would make the follow up of the subject impossible during the study treatment and follow up period. Any reason the subject cannot comply with study and study procedures.
- •Subjects receiving any other investigational agent within 4 weeks of Baseline/Day
- •Use of non-FDA approved (EUA or full approval)/off label treatments for COVID-
- •Lactating females.
- •History of any known chronic liver or kidney disease.
- •Subjects taking drugs with a Narrow Therapeutic Index such as Cyclosporine Digoxin Flecainide Lithium Phenytoin Sirolimus Theophylline, and Warfarin.
研究组 & 干预措施
Active Treatment
Tempol (MMB-02) 800 mg per Day (n=124)
干预措施: Tempol (Drug)
Placebo
Placebo (n=124)
干预措施: Placebo (Other)
结局指标
主要结局
Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19
时间窗: 14 Days from the date Randomization/First Dosing.
To evaluate the difference in the rate of sustained clinical resolution1 of symptoms of COVID-19 at Day 14 by evaluating the odds ratio of the rate of sustained clinical resolution1 of symptoms of COVID-19 between Tempol + SOC vs placebo + SOC at Day 14.
次要结局
- Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality(60 Days from Randomization/First Dosing.)
- Efficacy of Tempol on preventing hospitalization: Odds ratio of the rate of hospitalization(14 Days from the date Randomization/First Dosing.)
- Changes in functional status: Post COVID Functional Scale (PCFS)(7,14 and 21 Days from the date Randomization/First Dosing.)