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

NCT05417997 | Completed Phase 3 DMC

• 1 other identifier: APRON 2020-OK-01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Decrease in COVID-19, cold and flu viral load to become non detected or negative by Polymerase Chain Reaction.

  By PCR method.

  15 days

• Produce COVID-19 antibodies

  Produce COVID-19 antibodies from 0 au/mL up to \>10.0 aU/mL. Chemiluminescent microparticle immunoassay (CMIA)

  30 days

• Decrease in bacteria microbe load to become non detected or reduced.

  Reverse transcriptase polymerase chain reaction (TaqManqPCR)

  30 days

• Normalization of fever, respiratory rate, oxygen saturation and alleviation of cough.

  Clinical recovery time (normalization of fever, respiratory rate and oxygen saturation and alleviation of cough). NEWS2 Scoring system

  15 days

• Changes in hospitalization / recovery time, discharge from hospital

  Hospital records

  30 days

• Improvement in coronavirus symptoms including ferritin, d-dimer, CRP, lymphocyte count.

  Comprehensive metabolic panel (CMP)

  30 days

Secondary Outcomes (2)

• Reduction of diabetes blood sugar level

  30 days

• Increase HDL decrease LDL and triglycerides

  30 days

Study Arms (2)

Research Arm

EXPERIMENTAL

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.

Dietary Supplement: Kunamin®; Drug: Favipiravir; Drug: Enoxaparin; Drug: Lansoprazole; Drug: Paracetamol; Drug: Ceftriaxone/ Clarithromycin; Drug: Methylprednisolone

Control arm

PLACEBO COMPARATOR

According to MOH of Turkey, which required a standard treatment including the following drugs as placebo: * Favipiravir * Enoxaparin * Enoxaparin * Lansoprazole * Paracetamol * Ceftriaxone/ Clarithromycin * Methylprednisolone

Drug: Favipiravir; Drug: Enoxaparin; Drug: Lansoprazole; Drug: Paracetamol; Drug: Ceftriaxone/ Clarithromycin; Drug: Methylprednisolone

Interventions

Kunamin® DIETARY_SUPPLEMENT

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

Research Arm

Favipiravir DRUG

Antiviral medication used to treat influenza

Control arm; Research Arm

Enoxaparin DRUG

Anticoagulant medication

Control arm; Research Arm

Lansoprazole DRUG

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

Control arm; Research Arm

Paracetamol DRUG

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

Control arm; Research Arm

Ceftriaxone/ Clarithromycin DRUG

Inhibits the production of pneumolysin

Control arm; Research Arm

Methylprednisolone DRUG

Treat inflammation, severe allergies, flares of chronic illnesses

Control arm; Research Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• RAAS Nutritionals, LLC: lead
• Kayseri City Hospital: collaborator

Study Sites (1)

Kayseri City Hospital

Kayseri, Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Common Cold; Influenza, Human; Pneumonia, Bacterial

Interventions

favipiravir; Enoxaparin; Lansoprazole; Acetaminophen; Ceftriaxone; Clarithromycin; Methylprednisolone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Thiazines; Erythromycin; Macrolides; Polyketides; Lactones; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kieu Hoang

  RAAS Nutritionals, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The interventions were assigned to participants based on results of in vitro and in vivo studies on H1N1 virus and efficacy for interventions that were used in the study. Kunamin is a botanical drug containing no toxicity. The intervention contain KH good healthy cells (proteins). The intervention not only treat and cure but also can prevent COVID-19 for those who are infected with COVID-19 only by producing antibodies against COVID-19. Therefore, it can be used as a combined drug and oral vaccine to treat, cure and prevent COVID-19. Just like COVID-19 vaccine, the more interventions patients take, the longer period of protection. The strategy is determined by the principal investigator depending on the severity of the illness. The interventions can help prevent COVID-19.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 14, 2022
• Study Start: May 29, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: June 14, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)