A Randomized Double-blinded Placebo-controlled Outpatient Clinical Trial in High Risk Population Confirmed COVID-19 Patients Using Ivermectin and Doxycycline to Prevent COVID-19 Illness-related Hospitalization (COVIVER-OUT PLUS)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Decreased admission rate to the hospital secondary to respiratory illness related to COVID-19
研究概览
简要总结
The purpose of this Clinical trial is to explore the therapeutic benefits of Ivermectin and Doxycycline in different combinations in high risk patients diagnosed with COVID-19.
详细描述
Purpose of the study:
The purpose of this Clinical trial is to explore the therapeutic benefits of Ivermectin and Doxycycline in different combinations. The investigators are studying known medications at already FDA approved dosages for therapeutic benefit. The investigators are not seeking new indications for these medications.
Null Hypothesis:
The investigators hypothesize that treating high-risk populations positive for COVID-19 illness with Ivermectin, Doxycycline, or Ivermectin only in the outpatient setting will decrease hospitalizations related to COVID-19 illness in comparison with Placebo.
Sample Size: Minimum of 50 high risk COVID 19 positive patients who volunteer and provide consent to participate in this study to be placed in three different groups (A,B,C). Subjects are to be randomized 1:1:1 and enrolled in sequential order to Group A, then B, then C as they enroll. This distribution pattern will be followed for the entirety of the study.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Data analysis will be carried out using statistical package for the social sciences software (SPSS). Interim data analysis will be performed at three different levels of the number of participants starting at sample size 20, 30 and 50. If no significant findings are obtained from the data at N=50, then it will add more participants to the study to achieve statistical significance. Sponsor and Principal Investigator will defer data analysis to a statistician. A Data Monitoring Committee (DMC) is going to be established in order to review accumulating trial data by treatment group in order to monitor patient safety and efficacy, ensure validity and integrity of the trial and make benefit-risk assessment. This is going to be conducted by a third party external DMC.
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
- •Age greater than or equal to 18
- •Willing and able to provide verbal /telephonic/Personal or computer based Informed Consent
- •Experiencing symptoms of COVID-19 illness and tested positive for SARS CoV-2 with either PCR, NAAT or antigen testing
- •Residents in a Nursing Home or long-term care facility
- •Immunocompromised state, including solid organ transplant, HIV infection, other immune deficiency, immunosuppressant medication including systemic corticosteroids
- •Chronic lung disease, including Chronic Obstructive Pulmonary Disease (COPD), moderate to severe asthma, cystic fibrosis, pulmonary fibrosis
- •Cardiovascular Disease
- •Hypertension
- •Obesity (body mass index [BMI greater then or equal to 30 kg/m^2]
- •Diabetes Mellitus
- •Chronic Kidney Disease
- •Chronic Liver Disease
- •Cerebrovascular Disease
- •Neurological Disorders including dementia
- •Tobacco use disorders
- •Hematologic disorders, including sickle cell disease and thalassemia
- •We are also interested in including a vital population to protect, considered essential workers who may not fit into the above inclusion criteria:
- •Health care professionals and firefighters.
- •Government officials or employees.
- •Students and teachers.
- •Law enforcement agents and personnel.
- •Individuals who live with, and cannot isolate, from any of the above groups.
排除标准
- •Participants under the age of 18
- •Received any COVID vaccine within the last 30 days
- •Contraindications to Ivermectin or Doxycycline
- •History of Seizure Disorder or Epilepsy
- •History of Myocardial Infarction or Heart Attack within the last one month
- •Already receiving Ivermectin or Doxycycline for treatment of any other disease or disorder
- •Allergies to Ivermectin or Doxycycline including angioedema, severe asthma, exfoliative dermatitis, Steven Jonson syndrome or psoriasis
- •History of angioedema, exfoliative dermatitis, Steven Johnson syndrome, psoriasis
- •Currently Pregnant or planning to conceive soon
- •Breastfeeding
- •History of prior Clostridium Difficile infection
研究组 & 干预措施
Ivermectin plus Doxycycline
Ivermectin 200 mcg/kg on day 1 and day 2-plus doxycycline 100 mg tablets twice a day for seven days
Body Weight (kg) Single oral Dose number of 3 mg tablets of Ivermectin
15-24 kg 1 tablet
25-35 kg 2 tablets
36-50 kg 3 tablets
51-65 kg 4 tablets
66-79 kg 5 tablets
80-109 kg 6 tablets
>110 kg 7 tablets
干预措施: Ivermectin Tablets (Drug)
Ivermectin plus Doxycycline
Ivermectin 200 mcg/kg on day 1 and day 2-plus doxycycline 100 mg tablets twice a day for seven days
Body Weight (kg) Single oral Dose number of 3 mg tablets of Ivermectin
15-24 kg 1 tablet
25-35 kg 2 tablets
36-50 kg 3 tablets
51-65 kg 4 tablets
66-79 kg 5 tablets
80-109 kg 6 tablets
>110 kg 7 tablets
干预措施: Doxycycline Tablets (Drug)
Ivermectin plus Placebo
Ivermectin 200 mcg/kg on day 1 and day 2-plus placebo tablet twice a day for seven days
Body Weight (kg) Single oral Dose number of 3 mg tablets of Ivermectin and Placebo
15-24 kg 1 tablet
25-35 kg 2 tablets
36-50 kg 3 tablets
51-65 kg 4 tablets
66-79 kg 5 tablets
80-109 kg 6 tablets
>110 kg 7 tablets
干预措施: Ivermectin Tablets (Drug)
Ivermectin plus Placebo
Ivermectin 200 mcg/kg on day 1 and day 2-plus placebo tablet twice a day for seven days
Body Weight (kg) Single oral Dose number of 3 mg tablets of Ivermectin and Placebo
15-24 kg 1 tablet
25-35 kg 2 tablets
36-50 kg 3 tablets
51-65 kg 4 tablets
66-79 kg 5 tablets
80-109 kg 6 tablets
>110 kg 7 tablets
干预措施: Placebo (Drug)
Placebo plus Placebo
Placebo (number of tablets according to weight) plus placebo twice a day for seven days
Body Weight (kg) Single oral Dose number of 3 mg tablets of Placebo
15-24 kg 1 tablet
25-35 kg 2 tablets
36-50 kg 3 tablets
51-65 kg 4 tablets
66-79 kg 5 tablets
80-109 kg 6 tablets
>110 kg 7 tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Decreased admission rate to the hospital secondary to respiratory illness related to COVID-19
时间窗: 5 weeks
The investigators will be assessing for decreased admission rate to the hospital secondary to respiratory illness related to COVID-19. This will be assessed over the duration of 5 weeks.
次要结局
- Decrease in total duration of symptoms secondary to respiratory illness related to COVID-19(5 weeks)
- Assessment of Platelet Count(2 weeks)
- Assessment of Sodium level(2 weeks)
- Assessment of Potassium level(2 weeks)
- Assessment of Total Bilirubin level(2 weeks)
- Assessment of White Blood Cell Count(2 weeks)
- Assessment of Hematocrit level(2 weeks)
- Assessment of Creatinine level(2 weeks)
- Assessment of Albumin level(2 weeks)
- Assessment of Aspartate Aminotransferase level(2 weeks)
- Assessment of Alanine Aminotransferase level(2 weeks)
- Assessment of Hemoglobin level(2 weeks)
- Assessment of Glucose level(2 weeks)
- Assessment of Chloride level(2 weeks)
- Assessment of Carbon Dioxide level(2 weeks)
- Assessment of Blood Urea Nitrogen level(2 weeks)
- Assessment of Calcium level(2 weeks)
- Assessment of Total Protein level(2 weeks)
- Assessment of Alkaline Phosphatase level(2 weeks)
- Assessment of Ferritin(2 weeks)
- Assessment of D-dimer(2 weeks)
- Assessment of Creatine Phosphokinase(2 weeks)
- Assessment of C-Reactive Protein(2 weeks)
- Assessment of Prothrombin Time and International Normalized Ratio(2 weeks)
- Assessment of activated Partial Thromboplastin Time(2 weeks)
- Assessment of Fibrinogen Activity(2 weeks)
- Assessment of Interleukin 6 level(2 weeks)
- Assessment of Interleukin 6 receptor level(2 weeks)
- Assessment of Tumor Necrosis Factor Alpha level(2 weeks)
- Assessment of Tumor Necrosis Factor Alpha Receptor level(2 weeks)
- Mortality(5 weeks)
- Measurement of Participants with Medication Side Effects(5 weeks)
- Measurement of Participants with new onset Shortness of Breath or Changes in Shortness of Breath Severity(5 weeks)
- Measurement of Participants Pulse Oximetry readings on room air(5 weeks)
- Measurement of Participants with new onset Red Eyes or Changes in Red Eyes Severity(5 weeks)
- Measurement of Participants with new onset Chills or Changes in Chills Severity(5 weeks)
- Measurement of Participants with new onset Runny Nose or Changes in Runny Nose Severity(5 weeks)
- Measurement of Participants with new onset Sore Throat or Changes in Sore Throat Severity(5 weeks)
- Measurement of Participants with new onset Loss of Smell or Changes in Severity of in Loss of Smell(5 weeks)
- Measurement of Participants with new onset Loss of Taste or Changes in Severity of Loss of Taste(5 weeks)
- Measurement of Participants with new onset Body Aches or Body Pains or Changes in Body Aches or Body Pains Severity(5 weeks)
- Measurement of Participants with new onset Diarrhea or Changes in Diarrhea Severity(5 weeks)
- Measurement of Participants with new onset Headaches or Changes in Headaches Severity(5 weeks)
- Measurement of Participants with new onset Anxiety or Changes in Anxiety Severity(5 weeks)
- Measurement of Participants with new onset Fatigue or Changes in Fatigue Severity(5 weeks)
- Measurement of Participants with new onset Trouble Concentrating or Changes in Trouble Concentrating Severity(5 weeks)
- Measurement of Participants with new onset Cough or Changes in Cough Severity(5 weeks)
- Measurement of Participants with new onset Vomiting or Changes in Vomiting Severity(5 weeks)
- Measurement of Participants with new onset Nausea or Changes in Nausea Severity(5 weeks)
- Measurement of Participants with new onset Feelings of Hopelessness or Changes in Feelings of Hopelessness severity(5 weeks)
- Measurement of Participants with new onset feelings of Depression or Changes in feelings of Depression severity(5 weeks)
- Measurement of Participants with new onset Fever or Changes in Fever Severity(5 weeks)
- Measurement of Participants with new onset Moving Slowly or Changes in the Severity of Moving Slowly(5 weeks)
- Measurement of Participants with new onset Speaking Slowly or Changes in the Severity of Speaking Slowly(5 weeks)
- Measurement of Participants with new onset Feelings of Restlessness or Changes in the Severity of Feelings of Restlessness(5 weeks)
- Measurement of Participants with new onset Thoughts of Better Off Being Dead or Changes in the Severity of Thoughts of Better Off Being Dead(5 weeks)
- Measurement of Participants with new onset Thoughts of Hurting Yourself or Changes in the Severity of Thoughts of Hurting Yourself(5 weeks)
- Measurement of Participants with new onset Loss of Interest in Doing Things or Changes in the Severity of Loss of Interest in Doing Things(5 weeks)
- Measurement of Participants with new onset Loss of Pleasure in Doing Things or Changes in the Severity of Loss of Pleasure in Doing Things(5 weeks)
- Measurement of Participants with new onset Trouble Falling Asleep or Changes in the Severity of Trouble Falling Asleep(5 weeks)
- Measurement of Participants with new onset Trouble Staying Asleep or Changes in the Severity of Trouble Staying Asleep(5 weeks)
- Measurement of Participants with new onset Unmentioned Negative Impacts of COVID 19 infection or Changes in the Severity of these Negative Impacts of COVID 19 infection(5 weeks)