Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients

• Status: Completed
• Trial end date: 2021-12-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RAAS Nutritionals, LLC
• Collaborator: Kayseri City Hospital
• Treatments: Ceftriaxone; Clarithromycin; Enoxaparin; Favipiravir; Lansoprazole; Methylprednisolone

Criteria

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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