FLAVOVIR® (CAPSULES): EFFECTIVENESS IN COVID-19

The materials of the clinical trial "Multicenter, randomized, double-blind study of the efficacy and tolerability of FLAVOVIR® (capsules) in patients with moderate COVID-19 receiving basic therapy are presented". The investigational drug FLAVOVIR® (capsules) is a development of LLC "SPC "Ecopharm", presented for clinical study, in order to prove antiviral activity against SARS-CoV-2 viruses and to resolve the issue of the possibility of registering the drug in Ukraine as a direct-acting antiviral agent. FLAVOVIR® (capsules) is a new dosage form of the drug PROTEFLAZID® (drops), registered in Ukraine in 2001 and widely used. A clinical trial was conducted to confirm the predominant efficacy of FLAVOVIR® (capsules) in course doses against the background of standard baseline therapy in patients with COVID-19, moderate severity compared to placebo against the background of standard baseline therapy in patients with moderate COVID-19. Materials and methods. The study subjects were 162 patients with COVID-19 of moderate severity. Patients based on the method of block randomization in a ratio of 1:1:1 were divided into 3 groups of 54 patients. Patients of group I were prescribed the investigational drug FLAVOVIR® (capsules), orally 1 capsule 2 times a day for 14 days and, at the same time, placebo 1 capsule 2 times a day for 14 days (to ensure "double masking") against the background of standard basic therapy. Group II patients were prescribed the drug FLAVOVIR® (capsules), orally 2 capsules 2 times a day for 14 days against the background of standard basic therapy. Patients of group III were prescribed a placebo, capsules, orally 2 capsules 2 times a day for 14 days against the background of standard basic therapy. The effectiveness of treatment was evaluated taking into account the following primary efficacy variables: - time (in days) before the onset of an event characterized by the absence of hyperthermia (<37.0 °C) for at least 3 days in the absence or minimal severity of ARVI symptoms (≤1 point on a verbal analog scale: 0–3 points) within a 14-day period of taking the drug; - the time (in days) until the elimination of SARS-CoV-2 viruses from the nasopharyngeal smear within the 14-day period of taking the drug. The tolerance of the studied drugs was assessed on the basis of the patient's subjective complaints, the presence and severity of adverse reactions/side effects, the data of an objective examination of the patient and laboratory examination. Conclusions. Treatment with FLAVOVIR® (capsules) was found to be effective in 94.4% of group I patients, in 94.4% of group II patients and in 70.4% of group III patients. No statistically significant difference in the efficacy of treatment by primary variable between groups I and II was found. A statistically significant difference was found between groups I and III and groups II and III. The hypothesis of the prevailing efficacy of FLAVOVIR® (capsules) in two dosages compared to placebo against the background of standard baseline therapy in patients with moderate COVID-19. The study showed that the drug FLAVOVIR® (capsules) is effective in the treatment of patients with COVID-19, with a high percentage of positive results in groups I and II. Statistically significant differences between groups I and III and groups II and III have been demonstrated. The results of the study confirm the hypothesis about the effectiveness of FLAVOVIR® (capsules) in the treatment of COVID-19, which is an important contribution to clinical practice and scientific research. The drug FLAVOVIR® (capsules), which has a high potential as an antiviral agent in the treatment of moderate COVID-19, requires further research and registration in Ukraine.