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

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.

Conditions

• COVID-19 Respiratory Infection
• FLU
• Cold; Influenza
• Bacterial Pneumonia
• COVID-19 Pneumonia

Interventions

DIETARY_SUPPLEMENT

Kunamin®

Grape juice, seed, stem and rice extracts supplement containing KH good healthy cells (proteins)

DRUG

Favipiravir

Antiviral medication used to treat influenza

DRUG

Enoxaparin

Anticoagulant medication

DRUG

Lansoprazole

Treat stomach ulcers, a damaged esophagus, gastroesophageal reflux disease (GERD), and high levels of stomach acid.

DRUG

Paracetamol

Analgesic to treat minor aches and pains, and fever reducer.

DRUG

Ceftriaxone/ Clarithromycin

Inhibits the production of pneumolysin

DRUG

Methylprednisolone

Treat inflammation, severe allergies, flares of chronic illnesses

Sponsors & Collaborators

• Kayseri City Hospital

  collaborator OTHER_GOV

• RAAS Nutritionals, LLC

  lead INDUSTRY

Principal Investigators

• Kieu Hoang · RAAS Nutritionals, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-29

Primary Completion

2021-12-02

Completion

2021-12-02

Countries

• Turkey (Türkiye)

Study Locations