Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients
Status:
Completed
Trial end date:
2021-12-02
Target enrollment:
Participant gender:
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.