Randomized, Placebo-Controlled, Phase 2 Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Veru Inc.
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- Number of Subjects That Are Alive Without Respiratory Failure at Day 29.
研究概览
简要总结
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).
详细描述
This study is a multicenter, randomized, placebo-control, efficacy and safety study of VERU-111 for the treatment of COVID-19. Subjects will receive either 18 mg of VERU-111 or matching placebo orally or through nasogastric tube daily for to 21 days or until the subject is discharged from the hospital, whichever comes first.
The primary efficacy endpoint of the study will be the proportion of subjects that are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).
The total study duration for a subject from screening to follow up visit is planned to be 62 days.
An evaluation of the effect of VERU-111 on SARS-CoV-2 (COVID-19) compared to the placebo control will be evaluated after the last subject has completed Day 22. This will allow for the decision to move to Phase 3 more quickly if the Phase 2 portion of the study shows a clinically relevant difference in the proportion of subjects that are alive without respiratory failure at Day 22 in the VERU-111 treated groups compared to the Placebo treatment group and VERU-111 is well tolerated in the study.
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
Double Blind Randomized 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
- •Provide informed consent
- •Be able to communicate effectively with the study personnel
- •Aged ≥18 years
- •Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test
- •Patients at high risk for ARDS, with known comorbidities for being at high risk, such as, Asthma (moderate to severe), Chronic Lung Disease, Diabetes, Chronic Kidney Disease being treated with dialysis, Severe Obesity (BMI ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised
- •Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening
- •Subjects must agree to use acceptable methods of contraception
- •If subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
- •If female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
- •If female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
- •Subject is willing to comply with the requirements of the protocol through the end of the study
排除标准
- •Known hypersensitivity or allergy to colchicine
- •Participation in any other clinical trial of an experimental treatment for COVID-19
- •Concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against COVID-19 is prohibited < 24 hours prior to study drug dosing (except standard of care) Remdesivir and convalescent plasma is allowed as standard of care.
- •Requiring mechanical ventilation at screening
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >2 X upper limit of normal (ULN)
- •Total bilirubin > ULN
- •Creatinine clearance < 60 mL/min
- •Documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices
- •Moderate to severe renal impairment
- •Hepatic impairment
- •Positive for HbsAg, or HCV antibodies at screening
- •Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- •Participants must agree to refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU-111.
研究组 & 干预措施
Veru-111 18 mg
Veru-111 18mg capsules
干预措施: Veru-111 (Drug)
Placebo
Placebo capsules
干预措施: Veru-111 (Drug)
结局指标
主要结局
Number of Subjects That Are Alive Without Respiratory Failure at Day 29.
时间窗: Day 29
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 29. Respiratory failure is defined as endotracheal intubation and mechanical ventilation, extracorporeal membrane oxygenation, high-flow nasal cannula oxygen delivery, noninvasive positive pressure ventilation, clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation
次要结局
- Proportion of Subjects Alive and Discharged From Hospital by Visit(Day 15, Day 22 and Day 29)
- World Health Organization Ordinal Scale Clinical Improvement(Day 29)
- Patients Alive and Free of Respiratory Failure(Day 15 and Day 22)
- Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit(Day 15, Day 22 and Day 29)