A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Number of Subjects With COVID-19 Symptoms at Day 3.
研究概览
简要总结
The main aim of this study is to determine the effects of short-term treatment with hesperidin on COVID-19 symptoms in comparison with a placebo. Treatment effects will be observed through a symptoms diary that will be completed by participants throughout the study and by taking the oral temperature daily.
详细描述
This will be a randomized, double-blind, placebo-controlled study. The study will include subjects from Quebec diagnosed with COVID-19 infections. Following informed consent, 216 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either hesperidin 1000 mg once daily (q.d.)) or placebo (1:1 allocation ratio) for 14 days. Investigational drug will be delivered to the patients' homes with an electronic oral thermometer and a symptoms diary. Follow-up phone assessments will occur after 3, 7, 10, and 14 days following randomization for evaluation of COVID-19 symptoms. Electronic Case Report Form (eCRF) will be completed by the research personnel over the phone with the patients. The symptoms diary will be mailed back to the coordinating center at the end of the study in a pre-addressed envelope.
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)
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
- •Covid-19 positive by polymerase chain reaction (PCR) testing;
- •Participant must be able to evaluate their symptoms and report them in the symptoms diary;
- •Patients must be able to take their oral temperature daily with an electronic thermometer provided to them with study materials;
- •Males and females, at least 18 years of age, capable and willing to provide informed consent;
- •Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study;
- •Patient must have received a diagnosis of COVID-19 infection within the last 48 hours and have one or more symptoms;
- •Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);
- •Patient must be able and willing to comply with the requirements of this study protocol.
排除标准
- •Patient currently hospitalized or under immediate consideration for hospitalization;
- •Patient currently in shock or with hemodynamic instability;
- •Patient undergoing chemotherapy for cancer;
- •Patient is unable to take oral temperature using an electronic thermometer;
- •Patient who received at least one dose of the COVID-19 vaccine;
- •Female patient who is pregnant or breast-feeding or is considering becoming pregnant during the study;
- •People taking anticoagulant/antiplatelet medications, those with bleeding disorders, and people two weeks before or after surgery;
- •Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study;
- •Regular consumption of natural products containing more than 150 mg of hesperidin or regular consumption of more than 1 glass of orange juice per day;
- •Known allergy to any of the medicinal and non-medicinal ingredient: hesperidin, microcrystalline cellulose, magnesium stearate.
研究组 & 干预措施
Hesperidin 1000mg
Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
干预措施: Hesperidin (Drug)
Placebo 1000mg
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With COVID-19 Symptoms at Day 3.
时间窗: Day 3
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 3.
Number of Subjects With COVID-19 Symptoms at Day 7.
时间窗: Day 7
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 7.
Number of Subjects With COVID-19 Symptoms at Day 10.
时间窗: Day 10
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 10.
Number of Subjects With COVID-19 Symptoms at Day 14.
时间窗: Day 14
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 14.
次要结局
- Number of Subjects With the Cough Symptom.(Day 14)
- Number of Subjects With the Presence of Fever.(Day 14)
- Number of Subjects With the Presence of Feverish or Chills.(Day 14)
- Number of Subjects With the Presence of Runny Nose.(Day 14)
- Mean Number of COVID-19 Symptoms at Day 14.(Day 14)
- Number of Subjects With Complete Disappearance of Any Symptom.(From randomization to occurence of first event, assessed up to 14 days)
- Mean Number of COVID-19 Symptoms at Day 3.(Day 3)
- Number of Subjects With the Presence of Anosmia.(Day 14)
- Number of Subjects With the Presence of Sore Throat.(Day 14)
- Number of Subjects With the Presence of General Weakness.(Day 14)
- Number of Subjects With the Presence of Irritability/Confusion.(Day 14)
- Number of Subjects With the Presence of Shortness of Breath.(Day 14)
- Number of Subjects With the Presence of Pain.(Day 14)
- Number of Subjects With the Presence of Diarrhea.(Day 14)
- Mean Number of COVID-19 Symptoms at Day 10.(Day 10)
- Mean Number of COVID-19 Symptoms at Day 7.(Day 7)
- Number of Subjects With the Presence of Nausea/Vomiting.(Day 14)
- Number of Subjects With the Presence of Headache.(Day 14)