NCT04676867已完成2 期
A Double-blind, Placebo-controlled, Phase 2a Proof-of-concept Trial of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
DalCor Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2021年1月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Time to Sustained Clinical Resolution of Symptoms of COVID-19 (Excluding Cough, Sense of Smell and Taste) in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib
研究概览
简要总结
This study is a placebo-controlled, Phase 2a proof-of-concept clinical study which will evaluate efficacy and safety of dalcetrapib in outpatients patients with mild to moderate, symptomatic, confirmed COVID 19.
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
This is a double blind study.
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
- •Patients must satisfy all of the following criteria unless otherwise stated:
- •Willing and able to provide informed consent
- •Male or female patients > 18 years of age on the day of informed consent
- •Have received a confirmed diagnosis of COVID-19 (positive for SARS CoV 2), as assessed by PCR or point-of-care within 72 hours of first dose on Day 1
- •Have mild to moderate signs or symptoms of COVID-19 with onset within 5 days of first dose on Day 1, at least two of the following symptoms:
- •stuffy or runny nose
- •sore throat
- •shortness of breath
- •chills or shivering
- •feeling hot or feverish
- •Outpatient with COVID-19 disease (not requiring oxygen therapy [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 3])
- •Patient is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the informed consent form (ICF).
排除标准
- •Patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated:
- •Females who are pregnant (negative pregnancy test required for all women of child bearing potential at Screening) or breast-feeding
- •Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception
- •Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO])
- •Expected survival less than 72 hours
- •Peripheral capillary oxygen saturation (SpO2) <90% while breathing room air
- •Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently
- •History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the Investigator
- •Use of any other concurrent investigational drugs while participating in the present study
- •Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions)
- •Known renal disease with an estimated glomerular filtration rate (eGFR) <50 mL/min based on local laboratory results
- •Patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis
- •Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local laboratory results
- •Co administration of clinical doses of orlistat with dalcetrapib
- •Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn's disease) or malabsorption at Screening
- •Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study
- •History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.
研究组 & 干预措施
900 mg dose
Active Comparator
Patients will receive Dalcetrapib 900 mg for 10 days
干预措施: Dalcetrapib (Drug)
1800 mg dose
Active Comparator
Patients will receive Dalcetrapib 1800 mg for 10 days
干预措施: Dalcetrapib (Drug)
3600 mg dose
Active Comparator
Patients will receive Dalcetrapib 3600 mg for 10 days
干预措施: Dalcetrapib (Drug)
Placebo tablets
Placebo Comparator
Patients will receive Placebo for 10 days
干预措施: Placebo (Other)
结局指标
主要结局
Time to Sustained Clinical Resolution of Symptoms of COVID-19 (Excluding Cough, Sense of Smell and Taste) in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib
时间窗: 28 days
Sustained clinical resolution is defined as occurring when no key COVID-19 related symptom has a score higher than 1 over a 72-hour period (as documented using an electronic patient-reported outcome \[ePRO\] instrument), except for sense of smell and taste where the score should be 0 over a 72-hour period. The time to resolution was taken as the time from randomization until the first day of the last 72-hour period where the patient met the definition of resolution within 28 days. Patients who did not meet the definition of resolution 28 days after randomization were considered not resolved. The scale is "Assessment of 14 Common COVID-19-Related Symptoms: Items and Response" from the Food and Drug Administration (FDA). The symptoms are scored as on a scale of 0 to 3 for 12 of the symptoms where 0 is none and on a scale of 0 to 2 for the two other symptoms where 0 is "as usual". A higher score is a worse outcome.
次要结局
- Change From Baseline in log10 Viral Load (Saliva)(Screening/Baseline (Day -2 to Day -1), Day 3, Day 5, Day 10, and Day 28/End of Study (EOS))
- Mortality Rate by Day 28(Day 1 to Day 28)
- Time to Complete Clinical Resolution(28 days)
- Change From Baseline in log10 Viral Load (Nasal Swab)(Screening/Baseline (Day -2 to Day -1), Day 3, Day 5, Day 10, and Day 28/End of Study (EOS))
- Time to Sustained Complete Clinical Resolution of Symptoms in Subjects With Confirmed, Mild to Moderate, Symptomatic COVID-19 Treatment With Dalcetrapib(28 days)
- Viral Clearance Using Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR)(Day 1 to Day 28)
- Rate of Hospitalization Through Day 28(Day 1 to Day 28)
- Rate of Progression to Oxygen Therapy Through Day 28(Day 1 to Day 28)
- Duration of Hospitalization(Day 1 through Day 28)
- Time to Complete Clinical Resolution (Excluding Cough, Sense of Smell and Taste) Defined in the Same Way as the Primary Endpoint, But Considering That All Symptoms Must Resolve to a Score of 0 for 72 Hours(28 days)
- Scoring of World Health Organization (WHO) Clinical Outcome Scale (9-point Scale) at Screening, Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28(Screening (Day -2 to Day -1), Days 1, 3, 5, End of Treatment (Day 10), Follow-Up Visit (Day 14), and Day 28)
- Type of Oxygen Therapy Received Through Day 28(Day 1 to Day 28)
- Change From Baseline in Coronavirus Disease of 2019 (COVID-19) Total Symptom Severity Score Collected at All Time Points(Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 14 (follow-up visit 1), and Day 28 (end of study / follow-up visit 2))
研究者
研究点 (1)
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