"Efesovir" (FS-1) for COVID-19, Phase 2

Scientific Center for Anti-infectious Drugs (SCAID)

Status and phase: Not yet enrolling; Phase 2

Conditions: Covid19

Treatments: Drug: Efesovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05060705

CTP-FS-1-SE-2-05

Details and patient eligibility

About

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".

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

Efesovir

Experimental group

Description:

The patients of experimental arm take study drug Efesovir twice a day as an antiviral therapy in dose 0.125 ml / kg. Daily dose of Efesovir: 0.250 ml / kg. Duration of treatment is 5 - 10 days, depending on the severity of the disease.

Treatment:

Drug: Efesovir

Remdesivir

Active Comparator group

Description:

The patients are treated with the antiviral drug "Remdesivir" in dose 200 mg intravenously on the 1st day, then by 100 mg intravenously daily for 5 - 10 days, depending on the severity of the disease.

Treatment:

Drug: Efesovir