Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients
COVID-19 Respiratory Infection, FLU, Cold; Influenza
About this trial
This is an interventional treatment trial for COVID-19 Respiratory Infection
Eligibility 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
Sites / Locations
- Kayseri City Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Research Arm
Control 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.
According to MOH of Turkey, which required a standard treatment including the following drugs as placebo: Favipiravir Enoxaparin Enoxaparin Lansoprazole Paracetamol Ceftriaxone/ Clarithromycin Methylprednisolone