clinical trial to evaluate the tolerability, efficacy and safety of Aesculus Hippocastanum L seed extract in COVID-19 patients with mild pneumonia

INTERVENTION: Trade Name: Veinofytol Pharmaceutical Form: Tablet CONDITION: COVID‐19 patients with mild pneumonia Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: The primary objective of this clinical trial is to determine the therapeutic efficacy of; Aesculus Hippocastanum L. seed extract for the COVID‐19 disease treatment Primary end point(s): The study is aimed to determine whether the efficacy of Aesculus Hippocastanum L. seed; extract exceeds the efficacy of maintenance treatment in the control group of SARS‐CoV‐2; infected patients (Covid‐19 disease) with mild pneumonia.; The primary endpoint is determination of the period during which the Covid‐19 disease; clinical symptoms are reduced, and the patient's condition improves Secondary Objective: The study is aimed to determine whether the efficacy of Aesculus Hippocastanum L. seed; extract exceeds the efficacy of maintenance treatment in the control group of SARS‐CoV‐2; infected patients (Covid‐19 disease) with mild pneumonia.; The primary endpoint is determination of the period during which the Covid‐19 disease; clinical symptoms are reduced, and the patient's condition improves. Timepoint(s) of evaluation of this end point: Until the end of the clinical trial day 28. SECONDARY OUTCOME: Secondary end point(s): The clinical endpoints of the study, which require regular evaluation in relation to the; primary clinic of COVID‐19 disease in the assessment of general respiratory symptoms,; were selected as secondary endpoints based on their established relevance in clinical; practice. They are the following:; 1. Changes of patient condition (according to a 5‐point scale); 2. Time to the negative SARS‐CoV‐2 test (RT‐PCR); 3. Duration of pyrexia, normalization of body temperature, SpO2 records, and chest; radiographic imaging data; 4. Changes in expression of clinical symptoms and vital signs; 5. Chest imaging picture data on Days 0, 14 (evaluated data of changes); 6. The number (percentage) of patients requiring adjuvant O2 therapy; Duration of; oxygenotherapy (average); 7. Patients requiring treatment at intensive care department (percentage), requiring; mechanical ventilation therapy (percentage); 8. Clinical laboratory evaluation: white blood cell count, hemoglobin level, platelet count,; blood glucose concentration, serum total bilirubin, creatinine, ALT, AST, electrolytes; (Na+, K+), C‐reactive albumin, IL‐6, TNF‐alfa, ferritin over the study time. Timepoint(s) of evaluation of this end point: Until the end of the clinical trial day 28. INCLUSION CRITERIA: 1. Patient age: 18 to 75 years 2. The patient gave informed consent; patients who understand the essence of the study and can independently give the informed consent 3. A positive SARS‐CoV‐2 sample (nasopharyngeal swab) was determined by RT‐PCR 4. Patients diagnosed with new pneumonia lesions were identified by chest X‐ray 5. Patients who have a fever 6. Premenopausal women who had a negative pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5