A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Time to Non-Infectivity by RT-PCR
研究概览
简要总结
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
详细描述
Patients in this trial will undergo treatment for 10 days with either a combination of therapies or placebo. They will then be followed for an additional 20 days.
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
- Double (Participant, Investigator)
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
- •Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
- •Healthy male or female subjects at least 18 years of age
- •Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization will be stratified.
- •Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
- •Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. One of these must be a barrier method. Exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal)
- •Subjects must agree they will attend the treatment facility daily for 10d in the event of failure to attend, the patient will be visited at their home to collect the nasal swab and review data.
排除标准
- •Refusal to sign informed consent form
- •Negative test for COVID-19 by RT-PCR at screening
- •Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 104.0 degrees F, pleuritic pain, or frequent cough.
- •Known drug allergy to any of the investigational medications
- •Currently taking medication with known drug interactions with investigational medications, found in Appendix II
- •Prescription or other antiviral medications
- •Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
- •Inability to attend daily for 10 days
研究组 & 干预措施
Active Arm
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
干预措施: Ivermectin (Drug)
Active Arm
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
干预措施: Doxycycline Hcl (Drug)
Active Arm
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
干预措施: Zinc (Dietary Supplement)
Active Arm
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
干预措施: Vitamin D3 (Dietary Supplement)
Active Arm
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
干预措施: Vitamin C (Dietary Supplement)
Placebo
Placebo and Vitamin D3, Vitamin C, and Zinc
干预措施: Zinc (Dietary Supplement)
Placebo
Placebo and Vitamin D3, Vitamin C, and Zinc
干预措施: Vitamin D3 (Dietary Supplement)
Placebo
Placebo and Vitamin D3, Vitamin C, and Zinc
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
Time to Non-Infectivity by RT-PCR
时间窗: 6 months
Time to negative RT-PRC result indicating that patient is no longer infective
Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)
时间窗: 6 months
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)
时间窗: 6 months
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Efficacy of Treatment as measured by Titer
时间窗: 6 months
Patients will have serum stored for titer testing to compare antibody levels over time
Efficacy of Treatment as measured by RT-PCR
时间窗: 10 days
Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
次要结局
- Safety of Treatment as Measured by Electrolyte Levels(6 Months)
- Safety of Treatment as Measured by D-Dimer(6 Months)
- Safety of Treatment as Measured by Pro-Calcitonin(6 Months)
- Safety of Treatment as Measured by C-Reactive Protein(6 Months)
- Safety of Treatment as Measured by Ferritin(6 Months)
- Safety of Treatment as Measured by Liver Enzymes(6 Months)
- Safety of Treatment as Measured by Complete Blood Count(6 Months)
- Safety of Treatment as Measured by Treatment Related Adverse Events(6 months)