An Open-Label Randomized Study of Isoquercetin (IQC-950AN) Plus Standard of Care Versus Standard of Care Only for the Treatment of 2019 Novel Coronavirus Disease (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 150
- 主要终点
- Disease Progression
研究概览
简要总结
This is an open-label, randomized, multi-centre study where hospitalized subjects will be randomized in a 2:1 ratio to receive Isoquercetin (IQC-950AN) in addition to standard of care or standard of care only for 28 days following confirmation of a COVID-19 infection.
详细描述
The primary purpose of this randomized study will be to evaluate the effect of Isoquercetin (IQC-950AN) treatment on disease progression (defined as ≥ 6 on the World Health Organization (WHO) clinical progression scale) when given to subjects with confirmed COVID-19 in addition to standard of care. The secondary purpose of this study is to evaluate the effect of Isoquercetin (IQC-950AN) treatment on the reduction of severe acute respiratory coronavirus 2 (SARS-CoV-2) viral titers in these subjects and their recovery. In addition, certain parameters which may help elucidate the mechanism of action (sLDLR, PCSK9, sACE2, D-dimers and CRP) will be followed. The safety of Isoquercetin (IQC-950AN) will be evaluated at each visit. Subjects will be randomized to receive treatment for 28 days and then will return 30 days following the discontinuation of treatment for a final safety visit.
The results of this study will be used to design an adequately powered randomized controlled pivotal study to evaluate the efficacy and safety of Isoquercetin (IQC-950AN) in all or a subset of subjects with 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
- Single (Outcomes Assessor)
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 exhibit symptoms of COVID-19 disease at screening;
- •Patients must be 18 years of age or older, of either gender;
- •Patients must have a documented SARS-CoV-2 RNA-positive test virus within 3 days prior to randomization;
- •Patients must be admitted (or under observation to be admitted) to a controlled facility or hospital to receive standard-of-care for COVID-19 disease;
- •Patient's health status must be 3 (if hospitalized for comorbidities), 4, or 5 on the WHO clinical progression scale defined as hospitalized moderate disease (no oxygen therapy or oxygen by mask or nasal prongs);
- •If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control during the study and through 30 days after the last dose of the study medication.
- •Patients must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements;
- •Patients deemed capable of adequate compliance including attending scheduled visits for the duration of the study;
- •Patients must be able to swallow the study drug capsules
排除标准
- •Patients with a history of allergy or anaphylaxis to ingredients in Isoquercetin (IQC-950AN) including known intolerance of niacin or ascorbic acid or known glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- •Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis;
- •Patients receiving an intensified dose regimen of low molecular weight heparin (LMWH) or unfractionated heparin (defined as doses of LMWH or unfractionated heparin greater than those approved for thromboprophylaxis) or dual antiplatelet therapy;
- •Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure;
- •Patients with moderate or severe thrombocytopenia (platelet count <100 × 10⁹/L);
- •Patients who are breast-feeding an infant or child;
- •Patients who are pregnant or unwilling to use an appropriate form of contraception, except for heterosexual celibacy
- •Any other condition that, in the opinion of the investigator, may adversely affect the patient's ability to complete this study or its measures, or pose a significant risk to the patient;
- •Any reason the investigator suspects that data collected from this patient would be incomplete or of poor quality
研究组 & 干预措施
Isoquercetin (IQC-950AN)
1000 mg Isoquercetin b.i.d. on day 1, then 500 mg Isoquercetin b.i.d. for 27 more days, plus standard of care (as defined below)
干预措施: Isoquercetin (IQC-950AN) (Drug)
结局指标
主要结局
Disease Progression
时间窗: 28 days
Disease progression is defined as WHO Clinical Progression Scale ≥6, at any time between Day 1 and Day 28
次要结局
- Change in WHO Clinical Progression Scale score(28 days)
- Changes in LDL-cholesterol(29 days)
- Changes in viral load from baseline to end of treatment - Mean viral load(28 days)
- Changes in viral load from baseline to end of treatment - Area under the viral load vs. time profiles(28 days)
- Changes in viral load from baseline to end of treatment - Time profile of viral load(28 days)
- Changes in viral load from baseline to end of treatment - Percentage of patients that are viral negative(28 days)
- Progression to supplementary oxygen requirement(14 days)
- Disease Recovery(28 days)
- Incidence of all-cause mortality(30 days)
- Changes in D-dimer levels(29 days)
- Changes in liver enzymes(29 days)
- Incidence of mechanical ventilation(14 days)
- Incidence of ICU admission(14 days)
- Time to hospital discharge(29 days)
- Changes in serum C reactive protein levels (CRP)(29 days)
- Changes in soluble low-density lipoprotein receptor (sLDLR) expression and proprotein convertase subtilisin/kexin type 9 (PCSK9) and soluble angiotensin converting enzyme 2 (sACE2) levels(29 days)
- Changes in creatinine(29 days)