Official Title
Randomized Controlled Open Study of Safety and Preliminary Efficiency of the Drug "Efesovir" (Oral Solution) for Coronavirus Infection (COVID-19)
Brief Summary

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".

Detailed Description

Not Provided

Not yet recruiting
COVID19

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 59 Years
Countries
Kazakhstan
Locations

Semey Medical University
Semey, East-Kazakhstan Region, Kazakhstan

Investigator: Asel Zh Baibusinova, PhD
Contact: +7 (702)725-07-96
assel.baibussinova@nao-mus.kz

Contacts

Marina Lankina, PhD
+77057064410
m-lankina@list.ru

Gulshara Akhmetova, PhD
+77085348842
akhmetovagk@yandex.ru

Not Provided

Scientific Center for Anti-infectious Drugs, Kazakhstan
NCT Number
Keywords
COVID19
viral pneumonia
FS-1
Efesovir
MeSH Terms
COVID-19