Study of the efficacy and safety of the new drug "Efesovir" in comparison with the drug"Remdesivir" in the treatment of patients hospitalized with COVID-19.The hypothesis of clinical study is the clinical efficacy of new drug "Efesovir" is 10%to 30% higher than of "Remdesivir".
Not Provided
Drug: Efesovir
Antiviral therapy of COVID19 with Efesovir oral solution in dose 0.125 ml / kg two times
per day. Duration of treatment is 5 - 10 days, depending on the severity of the disease.
Other Name: FS-1
Inclusion Criteria:
- polymerase chain reaction (PCR) confirmed coronavirus infection (COVID-19) in
hospitalized patients with severe risk factors in age from 18 years to 59 years, of
both sexes, irrespective of national or ethnic origin
- the duration of the COVID-19 disease is no more than 10 days
- informed concent to participate in clinical trials
- informed concent to to use reliable contraceptive methods while participating in a
clinical trial
Exclusion Criteria:
- age less than 18 years old and over 59 years old
- pregnancy or breastfeeding
- hypersensitivity, allergy, intolerance to iodine, iodine-containing medicines
- hypersensitivity to Remdesivir or its components
- impaired consciousness, causing the impossibility of oral administration
- conditions or circumstances that, in the opinion of the investigator, may affect the
patient's safety or the quality of the results obtained
- participation in another clinical trial, including in the period up to 2 months
before this study
- signs of multiple organ failure
- alanine aminotransferase (ALT), aspartate aminotransferase (AST) is 5 or more times
higher than normal
- thrombocytopenia below 100 * 10^9/ l
- decrease in glomerular filtration rate (GFR) less than 30 ml / min by 1.73 m2
- chronic heart failure with reduced ejection fraction
- liver failure
- coagulopathy
- mechanical ventilation for 48 hours or more
- extracorporeal membrane oxygenation (ECMO)
- disseminated intravascular coagulation
Semey Medical University
Semey, East-Kazakhstan Region, Kazakhstan
Investigator: Asel Zh Baibusinova, PhD
Contact: +7 (702)725-07-96
assel.baibussinova@nao-mus.kz
Marina Lankina, PhD
+77057064410
m-lankina@list.ru
Gulshara Akhmetova, PhD
+77085348842
akhmetovagk@yandex.ru
Not Provided