Clinical trial NCT05060705: "Efesovir" (FS-1) for COVID-19, Phase 2
Official title: Randomized Controlled Open Study of Safety and Preliminary Efficiency of the Drug "Efesovir" (Oral Solution) for Coronavirus Infection (COVID-19)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Covid19
Keywords: COVID19
viral pneumonia
FS-1
Efesovir
Lead sponsor: Scientific Center for Anti-infectious Drugs, Kazakhstan
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to the one of two parallel groups: 1) treated with study drug "Efesovir"; 2) treated with referent drug "Remdesivir".
Primary purpose: TREATMENT

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".


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

Primary outcomes:
measure: Clinical Response Rate
timeFrame: 21 days
Secondary outcomes:
measure: Early Clinical Response Rate
timeFrame: 72 hours (3 days) of study drug treatment
measure: Early Clinical Response Rate in pneumonia
timeFrame: 72 hours (3 days) of study drug treatment
measure: Percentage of clinically stable patients
timeFrame: 72 hours (3 days) of study drug treatment
measure: Survival rate
timeFrame: 21 days
measure: Clinical Status Change
timeFrame: 7 days
measure: Adverse Events (AE)
timeFrame: up to 21 days
measure: Thyroid gland function
timeFrame: Day 21
Other outcomes:
Locations:
city: Semey
country: Kazakhstan
facility: Semey Medical University
state: East-Kazakhstan Region
Study officials:
References: