Method for treating RNA viral infections, including COVID-19 (SARS-CoV-2)

Abstract

This invention relates to a novel method for treating RNA viral infections including COVID-19 (SARS-CoV-2).

A method for treating RNA viral infections, including COVID-19 (SARS-CoV-2), which consists in administering to the patient a pharmaceutical composition in the form of a tablet, capsule, pill, or powder containing Favipiravir as the active ingredient at a dose of ≥40 mg/kg/day on day 1 and at a dose of ≥16 mg/kg/day on subsequent days until the virus leaves the body, optionally in combination with concomitant medications.

Claims

1. A method for treating RNA viral infections, including COVID-19 (SARS-CoV-2), which consists in administering to the patient a pharmaceutical composition in the form of a tablet, capsule, pill, or powder containing Favipiravir as the active ingredient at a dose of ≥40 mg/kg/day on day 1 and at a dose of ≥16 mg/kg/day on subsequent days until the virus leaves the body, optionally in combination with concomitant medications.

2. The method according to claim 1, wherein the dose of Favipiravir administered to a patient with a body weight less than 75 kg is 1600 mg 2 times a day on day 1 and 600 mg 2 times a day on subsequent days.

3. The method according to claim 1, wherein the dose of Favipiravir administered to a patient with a body weight from 75 kg to 90 kg is 2000 mg 2 times a day on day 1 and 800 mg 2 times a day on subsequent days.

4. The method according to claim 1, wherein the dose of Favipiravir administered to a patient with a body weight over 90 kg is 2400 mg 2 times a day on day 1 and 1000 mg 2 times a day on subsequent days.

5. The method according to any of claims 1-4, wherein a concomitant medication is administered, which is selected from the series of analgesics, anticoagulants, antibacterial drugs for systemic use, plasma-substituting and perfusion solutions, antitussive drugs and anti-cold agents, beta-blockers, vitamins, diuretics, drugs for diseases associated with impaired acidity, drugs that affect the renin-angiotensin system, drugs for diabetes, calcium channel blockers, corticosteroids for systemic use, drugs for heart diseases, antidiarrhoeal drugs, antiprotozoal drugs, immunosuppressants, drugs for thyroid diseases, drugs for obstructive respiratory diseases, antitumor hormonal drugs, hypolipidemic drugs, other drugs for gastrointestinal diseases and metabolic disorders.

6. The method according to claim 5, wherein the concomitant medication is selected from the series of analgesics, anticoagulants, antibacterial drugs for systemic use, plasma-substituting and perfusion solutions, antitussive drugs, anti-cold agents, and vitamins.

Description

[0022] This invention is illustrated by, but not limited to, the following example.

[0023] Example. “Adaptive, multicenter, randomized, open-label, comparative clinical study of the efficacy and safety of Avifavir in moderate-severity patients hospitalized with COVID-19.”

[0024] Study objective: Evaluation of the antiviral effect of Avifavir (tablets containing 200 mg of FVP as the active ingredient [Patent application RU 2020116521 of 07.05.20]) based on the rapidity of SARS-CoV-2 elimination.

[0025] The study involved 60 patients with a confirmed new coronavirus infection (COVID-19) of moderate severity who were admitted to infectious departments of clinical centers.

[0026] Patients were randomized into 3 study therapy groups. Group 1 (20 patients): the FVP dose was 1600 mg 2 times on day 1, then 600 mg 2 times a day for 13 days. Group 2 (20 patients): the FVP dose was1800 mg 2 times on day 1, then 800 mg 2 times a day for 13 days.

[0027] Depending on the condition, the patients of both groups took, along with FVP, concomitant medications, including: analgesics, anticoagulants, antibacterial drugs for systemic use, plasma-substituting and perfusion solutions, antitussive drugs and anti-cold agents, beta-blockers, vitamins, diuretics, drugs for diseases associated with impaired acidity, drugs that affect the renin-angiotensin system, drugs for diabetes, calcium channel blockers, corticosteroids for systemic use, drugs for heart diseases, Antidiarrhoeal drugs, Antiprotozoal drugs, immunosuppressants, drugs for thyroid diseases, drugs for obstructive respiratory diseases, antitumor hormonal drugs, hypolipidemic drugs, other drugs for gastrointestinal diseases and metabolic disorders.

[0028] Most often, the patients took, along with FVP, concomitant medications selected from the series of analgesics, anticoagulants, antibacterial drugs for systemic use, plasma-substituting and perfusion solutions, antitussive drugs, anti-cold agents, and vitamins.

[0029] The patients of the standard therapy group (20 people) took, depending on a particular patient's condition, Chloroquine, Azithromycin, Amoxiclav, Azithromycin+Hydroxychloroquine, Azithromycin+Ceftriaxone or Azithromycin+Lopinavir+Ritonavir.

[0030] At the time of inclusion in the study, 27% of patients required oxygen support and 37% were at risk for severe disease (age over 60 and/or presence of chronic comorbidities). The average duration of the disease from the onset of the first symptoms to the beginning of the study therapy was 7 days. Among the most common symptoms of the disease were fever above 37.5° (95%), cough (83%), weakness (70%), anosmia (35%), chest congestion (30%), and shortness of breath (28%). Initial parameters indicate a slightly lighter course of the disease in the standard therapy group (saturation within the normal range in 95% of patients, 45% of young patients).

[0031] Clinical studies of the drug Avifavir, which includes FVP as the active ingredient, showed that the median daily FVP dose on day 1 per 1 kg of body weight in patients with a negative PCR test result for SARS-CoV-2 4 days after the start of treatment was 44 mg/kg, and in patients with a positive test result, 39 mg/kg. For an FVP dose of ≥43 mg/kg on day 1, the viral elimination rate was 79%, and in patients who took <43 mg/kg, 44%. The median viral elimination in patients took 4 days against 9 in the case of standard therapy. In 68% of patients who took Avifavir, the body temperature normalized on day 3, while in the control group, on day 6. The average viral clearance in Avifavir-treated patients took 4 days, while in the standard therapy group, 9 days. After the first 4 days of treatment, 65% out of 40 patients treated with Avifavir had a negative test result for coronavirus, which is 2 times higher than in the standard therapy group (30%). By day 10, the number of patients with a negative test result reached 35 out of 40.