A Phase II, Multi-centre Open Label Study to Assess the Efficacy and Safety of Oral Apabetalone With Background Dapagliflozin in Subjects With Long -COVID-19 (Post-COVID-19 Conditions) and Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- patient acceptable symptom state (PASS)
研究概览
简要总结
This is an open label, multicentre, phase II clinical trial that aims to assess the efficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeks in T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, with symptoms within 3 months from the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis.
详细描述
This is an open label, multicentre, phase II clinical trial that aims to assess the efficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeks in T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, with symptoms within 3 months from the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis. Subjects will be receiving background therapy with dapagliflozin 10 mg daily.
In-person clinic visits will be used to collect data to assess the primary and secondary and exploratory endpoints. There will be 7 in-person visits.
After signing the informed consent form (ICF), and after all screening procedures have been performed, subject data will be reviewed by the Principal Investigator to determine subject eligibility. Eligible subjects will return for Visit 2 (Day 1) and assessments will be performed per the Schedule of Events. Subjects will be enrolled and treatment with Oral Apabetalone 100mg will be initiated. Subjects will be dispensed study drug to be administered at home with meals, twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Able and willing to provide written (signed and dated) informed consent before participation in the study, and to comply with scheduled visits, treatment plan, and other study-related procedures to complete the study.
- •Male or female subjects who are ≥ 18 years of age at Screening.
- •Documented diagnosis of T2DM (one or more of the following criteria must be met):
- •Documented history of T2DM
- •History of taking diabetes medication
- •HbA1c ≥6.5% at Screening
- •Must be taking dapagliflozin as part of their diabetes medication, or, based on the Principal Investigator's judgment and indication, be willing to commence sponsor-provided dapagliflozin 10 mg daily for the duration of the study.
- •History of Long-COVID symptoms within 3 months from the onset of COVID-19 that have lasted for at least 2 months. Symptoms are listed in Long Covid Symptom Tool (LCST).
- •A Long Covid Impact Tool (LCIT) score of ≥ 30 at the Screening Visit and at Visit 2 (Day 1)
- •A negative SARS-CoV-2 test at the Screening Visit and at Visit 2 (Day 1)
- •Female subjects of childbearing potential and nonsterile male subjects with female partners of childbearing potential must agree to either remain abstinent or use highly effective non-hormonal methods of contraception throughout the study and at least 30 days after the last dose of study drug has been taken. Subjects must adhere to contraceptive use consistent with local regulations regarding the methods of contraception for those participating in clinical studies
排除标准
- •Subjects with chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m2
- •New York Heart Association Class IV congestive heart failure
- •Evidence of cirrhosis from liver imaging or biopsy, a history of hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure; chronic liver diseases such as primary biliary cholangitis, untreated hemochromatosis, and primary sclerosing cholangitis
- •Subject meets any of the following laboratory criteria at Screening:
- •Alanine transaminase (ALT) or aspartate transaminase (AST) values > 1.5x the upper limit of normal (ULN)
- •Total bilirubin >1.5 × ULN.
- •Evidence of an active hepatitis B virus or hepatitis C virus infection
- •History of a positive test for human immunodeficiency virus (HIV)
- •Subjects taking concomitant cytochrome P450 3A4 strong inducers and/or strong inhibitors, or corticosteroid use >10 mg daily prednisone or equivalent.
- •Subjects who have received a COVID-19 vaccine or booster in the last 30 days prior to screening (Visit 1).
- •Subject who have participated in a clinical study and received any investigational medication within the last 30 days prior to screening (Visit 1).
- •Female subjects who are pregnant, planning to get pregnant, lactating/breastfeeding, or has a positive urine pregnancy test at the Screening Visit or prior to enrollment at the Day 1 visit.
- •Subjects whose safety may be compromised by study participation or are not, in the opinion of the investigator, able or willing to comply with the protocol.
研究组 & 干预措施
apabetalone
apabetalone selectively binds to the second bromodomain [BD2] of bromodomain extra terminal (BET) proteins, curbing the transcription of multiple disease associated genes that promote vascular inflammation, complement, acute phase response (APR), fibrosis, dyslipidemia, and vascular calcification.
干预措施: Apabetalone (Drug)
结局指标
主要结局
patient acceptable symptom state (PASS)
时间窗: 90 days
The PASS assessment will consist of a single question phrased verbally by the delegated administrator as " Taking into account all your symptoms in daily life and your functional impairment, do you consider that your current state is satisfactory?". The response options are "Yes" or "No".
次要结局
- Long COVID Symptom and Impact tools (LCST/LCIT)(90 days)
- Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a (SF-7a)(90 days)
- Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI)(90 days)
- Post-COVID-19 Functional Status (PCFS) Scale(90 days)
- DePaul Symptom Questionnaire - Post-Exertional Malaise Short Form (DSQ-PEM)(90 days)