"Efesovir" (FS-1) for COVID-19, Phase 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Efesovir.
- Who it may be relevant to
- Registry conditions: Covid19. Basic parameters: 18 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kazakhstan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Open Study of Safety and Preliminary Efficiency of the Drug "Efesovir" (Oral Solution) for Coronavirus Infection (COVID-19)
Overview
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".
Interventions
- 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.
Primary outcome measures
- Clinical Response Rate [Time frame: 21 days]
Secondary outcome measures (7)
- Early Clinical Response Rate [Time frame: 72 hours (3 days) of study drug treatment]
- Early Clinical Response Rate in pneumonia [Time frame: 72 hours (3 days) of study drug treatment]
- Percentage of clinically stable patients [Time frame: 72 hours (3 days) of study drug treatment]
- Survival rate [Time frame: 21 days]
- Clinical Status Change [Time frame: 7 days]
- Adverse Events (AE) [Time frame: up to 21 days]
- Thyroid gland function [Time frame: Day 21]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Kazakhstan · 1 center
- Semey Medical University — Semey
Identifiers
NCT: NCT05060705 · CTP-FS-1-SE-2-05