Evaluation of Effects, Safety, Viral Load and Antibody Level of Functional Food Dietary Supplement Containing Grape Products in Controlled, Randomized Study Using SARSCoV-2 RT-PCR Positive Covid-19 Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Decrease in COVID-19, cold and flu viral load to become non detected or negative by Polymerase Chain Reaction.
研究概览
简要总结
The primary objective of this study is to determine the safety and efficacy profile of the food supplement (KUNAMIN®) containing grape juice, seed, stem, and bark given to patients treated with the established treatment regimen against novel coronavirus infectious disease (COVID-19) via comparing Kunamin® group versus control group in a clinical trial.
In this study, both the therapeutic effect and the safety of the Kunamin® product has been evaluated. The study has been conducted on COVID-19 infected patients. Within the scope of the study, Covid-19 patients consisting of male and female patients are examined to evaluate the therapeutic effect.
COVID-19 infected patients are divided into 2 groups and the treatment group received grape food supplements for 15 days in addition to their standard treatment. The other group received only standard therapy. The effects of supplements containing grape products on the COVID-19 infection process of patients are investigated, as indicated in the primary, secondary, and tertiary endpoints. For this purpose, both the observation of routine examination findings and the effectiveness of food supplements on viral load and antibody levels are investigated. In the follow-up that continues for 30 days, COVID-19 Rapid Antigen test made in USA approved by FDA is used to monitor the efficacy of Kunamin® as patient treated by Kunamin® viral load is diminished either after 5 days, 10 days or 15 days, COVID-19 Rapid Antibody test made in USA approved by FDA has been used to monitor the development of IgM and IgG antibodies on day 0, day 5th, day 10th, day 15th and day 30th in addition to PCR test of Perkinelmer by Kayseri hospital. In conjunction, the sponsor used AIT Laboratories A HealthTrackRx Company PCR test CLIA and FDA approved for not only COVID-19 but also 27 kinds of cold and flu viruses and 90 different kinds of bacteria.
The number of patients planned for randomization was 240, however due to dropouts the hospital was able to screen 132 patients. Out of 132 patients we were able to enroll randomized total of 71 patients, 47 patients in the research arm and 24 in the control arm.
详细描述
We conducted a medical observation from December 2019 when there were no cases and no deaths in America, and just the revelation of this new disease in China. There is still no cure for COVID-19, a very contagious disease that has a tendency to destroy the immune system and has caused many mysterious complications while vaccination is a long-term strategy.
The complete study involved 100 outpatients from January 2020 to February 2021 who attended our clinic with flu, cold and respiratory symptoms, studied with a panel of 27 viruses and 90 bacteria which has been considered as phase 1 and phase 2 clinical trial for Kunamin® in the United States of America.
The sponsor also contracted with CRO APRON in Turkey to conduct the third phase clinical trial for Kunamin® for COVID-19 inpatients in Kayseri City Hospital. The number of patients planned for randomization was 240, however due to dropouts, we were able to screen 132 patients. Out of these 132 patients, we enrolled a total of 71 patients and randomized 47 patients in the research arm and 24 in the control arm.
The median age for COVID-19 positive patients is 39.6 years old (range of 18-64 years). Forty (56%) are female and 31 (44%) are male. The demographics include all Caucasians.
3 (4%) out of 71 patients after 40 capsules of Kunamin® were admitted into ICU and intubated, 100% survived.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Uncomplicated, mild or moderate pneumonia according to the T.R. Ministry of Health COVID-19 guidelines,
- •Adult patients diagnosed with COVID-19
- •Being between the age of 18 and 65
- •Adult patients diagnosed with COVID-19 by PCR and who have COVID-19 symptoms in CT scan
- •Patients who are positive for 2019-nCOVRNA in the test performed on samples taken from the nasopharyngeal area
- •Respiratory rate less than 30 / minute
- •SpO2 level above 90% in room air
- •Finding signs of pneumonia on chest x-ray or tomography
- •Having symptoms of COVID19
- •Having the skills to understand and approve the informed consent form
- •Patients with mild to moderate pneumonia findings according to the above criteria and decided to be treated only in hospital,
排除标准
- •Those who are allergic to grape juice and seed extract and / or other drugs and / or excipients of the products included in the standard treatment regimen,
- •Pregnant or breastfeeding women
- •Those who are not suitable for oral medication
- •Patients who have comorbidity and using medication because of their chronic illness
- •SpO2 level below 90% in room air
- •Those who have diffuse pneumonia findings in chest tomography and radiography
- •Patients who are being isolated and treated at home
研究组 & 干预措施
Research Arm
Kunamin® 20 capsules 500mg daily plus; Standard therapy interventions determined and prescribed by investigators including:
- Favipiravir: 1,600 mg (8 tablets) by mouth twice daily for 5 days.
- Enoxaparin: 40 mg SQ daily if D-dimer < 3000 ng/mL *or* plt < 100,000
- Enoxaparin: 0.5 mg/kg SQ twice daily if D-dimer >3000 ng/mL *and* plt < 100,000
- Lansoprazole: 30 mg (one tablet) by mouth, once a day for 7 days.
- Paracetamol: 500 mg (one tablet) by mouth, up to one tablet every 4 to 6 hours in case of fever (100.4°F/38°C or higher).
- Ceftriaxone: 500 mg IV once a day for 5-7 days.
- Clarithromycin: 250 mg (one tablet) twice a day for 5-7 days.
- Methylprednisolone: 80 mg/kg IV bolus, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h.
干预措施: Kunamin® (Dietary Supplement)
Research Arm
Kunamin® 20 capsules 500mg daily plus; Standard therapy interventions determined and prescribed by investigators including:
- Favipiravir: 1,600 mg (8 tablets) by mouth twice daily for 5 days.
- Enoxaparin: 40 mg SQ daily if D-dimer < 3000 ng/mL *or* plt < 100,000
- Enoxaparin: 0.5 mg/kg SQ twice daily if D-dimer >3000 ng/mL *and* plt < 100,000
- Lansoprazole: 30 mg (one tablet) by mouth, once a day for 7 days.
- Paracetamol: 500 mg (one tablet) by mouth, up to one tablet every 4 to 6 hours in case of fever (100.4°F/38°C or higher).
- Ceftriaxone: 500 mg IV once a day for 5-7 days.
- Clarithromycin: 250 mg (one tablet) twice a day for 5-7 days.
- Methylprednisolone: 80 mg/kg IV bolus, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h.
干预措施: Favipiravir (Drug)
Research Arm
Kunamin® 20 capsules 500mg daily plus; Standard therapy interventions determined and prescribed by investigators including:
- Favipiravir: 1,600 mg (8 tablets) by mouth twice daily for 5 days.
- Enoxaparin: 40 mg SQ daily if D-dimer < 3000 ng/mL *or* plt < 100,000
- Enoxaparin: 0.5 mg/kg SQ twice daily if D-dimer >3000 ng/mL *and* plt < 100,000
- Lansoprazole: 30 mg (one tablet) by mouth, once a day for 7 days.
- Paracetamol: 500 mg (one tablet) by mouth, up to one tablet every 4 to 6 hours in case of fever (100.4°F/38°C or higher).
- Ceftriaxone: 500 mg IV once a day for 5-7 days.
- Clarithromycin: 250 mg (one tablet) twice a day for 5-7 days.
- Methylprednisolone: 80 mg/kg IV bolus, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h.
干预措施: Enoxaparin (Drug)
Research Arm
Kunamin® 20 capsules 500mg daily plus; Standard therapy interventions determined and prescribed by investigators including:
- Favipiravir: 1,600 mg (8 tablets) by mouth twice daily for 5 days.
- Enoxaparin: 40 mg SQ daily if D-dimer < 3000 ng/mL *or* plt < 100,000
- Enoxaparin: 0.5 mg/kg SQ twice daily if D-dimer >3000 ng/mL *and* plt < 100,000
- Lansoprazole: 30 mg (one tablet) by mouth, once a day for 7 days.
- Paracetamol: 500 mg (one tablet) by mouth, up to one tablet every 4 to 6 hours in case of fever (100.4°F/38°C or higher).
- Ceftriaxone: 500 mg IV once a day for 5-7 days.
- Clarithromycin: 250 mg (one tablet) twice a day for 5-7 days.
- Methylprednisolone: 80 mg/kg IV bolus, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h.
干预措施: Lansoprazole (Drug)
Research Arm
Kunamin® 20 capsules 500mg daily plus; Standard therapy interventions determined and prescribed by investigators including:
- Favipiravir: 1,600 mg (8 tablets) by mouth twice daily for 5 days.
- Enoxaparin: 40 mg SQ daily if D-dimer < 3000 ng/mL *or* plt < 100,000
- Enoxaparin: 0.5 mg/kg SQ twice daily if D-dimer >3000 ng/mL *and* plt < 100,000
- Lansoprazole: 30 mg (one tablet) by mouth, once a day for 7 days.
- Paracetamol: 500 mg (one tablet) by mouth, up to one tablet every 4 to 6 hours in case of fever (100.4°F/38°C or higher).
- Ceftriaxone: 500 mg IV once a day for 5-7 days.
- Clarithromycin: 250 mg (one tablet) twice a day for 5-7 days.
- Methylprednisolone: 80 mg/kg IV bolus, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h.
干预措施: Paracetamol (Drug)
Research Arm
Kunamin® 20 capsules 500mg daily plus; Standard therapy interventions determined and prescribed by investigators including:
- Favipiravir: 1,600 mg (8 tablets) by mouth twice daily for 5 days.
- Enoxaparin: 40 mg SQ daily if D-dimer < 3000 ng/mL *or* plt < 100,000
- Enoxaparin: 0.5 mg/kg SQ twice daily if D-dimer >3000 ng/mL *and* plt < 100,000
- Lansoprazole: 30 mg (one tablet) by mouth, once a day for 7 days.
- Paracetamol: 500 mg (one tablet) by mouth, up to one tablet every 4 to 6 hours in case of fever (100.4°F/38°C or higher).
- Ceftriaxone: 500 mg IV once a day for 5-7 days.
- Clarithromycin: 250 mg (one tablet) twice a day for 5-7 days.
- Methylprednisolone: 80 mg/kg IV bolus, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h.
干预措施: Ceftriaxone/ Clarithromycin (Drug)
Research Arm
Kunamin® 20 capsules 500mg daily plus; Standard therapy interventions determined and prescribed by investigators including:
- Favipiravir: 1,600 mg (8 tablets) by mouth twice daily for 5 days.
- Enoxaparin: 40 mg SQ daily if D-dimer < 3000 ng/mL *or* plt < 100,000
- Enoxaparin: 0.5 mg/kg SQ twice daily if D-dimer >3000 ng/mL *and* plt < 100,000
- Lansoprazole: 30 mg (one tablet) by mouth, once a day for 7 days.
- Paracetamol: 500 mg (one tablet) by mouth, up to one tablet every 4 to 6 hours in case of fever (100.4°F/38°C or higher).
- Ceftriaxone: 500 mg IV once a day for 5-7 days.
- Clarithromycin: 250 mg (one tablet) twice a day for 5-7 days.
- Methylprednisolone: 80 mg/kg IV bolus, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h.
干预措施: Methylprednisolone (Drug)
Control arm
According to MOH of Turkey, which required a standard treatment including the following drugs as placebo:
- Favipiravir
- Enoxaparin
- Enoxaparin
- Lansoprazole
- Paracetamol
- Ceftriaxone/ Clarithromycin
- Methylprednisolone
干预措施: Favipiravir (Drug)
Control arm
According to MOH of Turkey, which required a standard treatment including the following drugs as placebo:
- Favipiravir
- Enoxaparin
- Enoxaparin
- Lansoprazole
- Paracetamol
- Ceftriaxone/ Clarithromycin
- Methylprednisolone
干预措施: Enoxaparin (Drug)
Control arm
According to MOH of Turkey, which required a standard treatment including the following drugs as placebo:
- Favipiravir
- Enoxaparin
- Enoxaparin
- Lansoprazole
- Paracetamol
- Ceftriaxone/ Clarithromycin
- Methylprednisolone
干预措施: Lansoprazole (Drug)
Control arm
According to MOH of Turkey, which required a standard treatment including the following drugs as placebo:
- Favipiravir
- Enoxaparin
- Enoxaparin
- Lansoprazole
- Paracetamol
- Ceftriaxone/ Clarithromycin
- Methylprednisolone
干预措施: Paracetamol (Drug)
Control arm
According to MOH of Turkey, which required a standard treatment including the following drugs as placebo:
- Favipiravir
- Enoxaparin
- Enoxaparin
- Lansoprazole
- Paracetamol
- Ceftriaxone/ Clarithromycin
- Methylprednisolone
干预措施: Ceftriaxone/ Clarithromycin (Drug)
Control arm
According to MOH of Turkey, which required a standard treatment including the following drugs as placebo:
- Favipiravir
- Enoxaparin
- Enoxaparin
- Lansoprazole
- Paracetamol
- Ceftriaxone/ Clarithromycin
- Methylprednisolone
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Decrease in COVID-19, cold and flu viral load to become non detected or negative by Polymerase Chain Reaction.
时间窗: 15 days
By PCR method.
Decrease in bacteria microbe load to become non detected or reduced.
时间窗: 30 days
Reverse transcriptase polymerase chain reaction (TaqManqPCR)
Normalization of fever, respiratory rate, oxygen saturation and alleviation of cough.
时间窗: 15 days
Clinical recovery time (normalization of fever, respiratory rate and oxygen saturation and alleviation of cough). NEWS2 Scoring system
Produce COVID-19 antibodies
时间窗: 30 days
Produce COVID-19 antibodies from 0 au/mL up to \>10.0 aU/mL. Chemiluminescent microparticle immunoassay (CMIA)
Changes in hospitalization / recovery time, discharge from hospital
时间窗: 30 days
Hospital records
Improvement in coronavirus symptoms including ferritin, d-dimer, CRP, lymphocyte count.
时间窗: 30 days
Comprehensive metabolic panel (CMP)
次要结局
- Reduction of diabetes blood sugar level(30 days)
- Increase HDL decrease LDL and triglycerides(30 days)