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

NCT05060705 | Not Yet Recruiting Phase 2

• 1 other identifier: CTP-FS-1-SE-2-05
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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".

Conditions

Covid19

Keywords

COVID19; viral pneumonia; FS-1; Efesovir

Outcome Measures

Primary Outcomes (1)

• Clinical Response Rate

  Clinical Response Rate is calculated as the number of trial subjects with effective treatment over the total number of subjects multiplied by 100. It is calculated in each study group. Measured in percents. The outcome is estimated among randomized subjects completed clinical study with the protocol requirements (per protocol population (PPP)). Clinical response is evaluated as effective treatment if: all signs and symptoms of COVID19 are resolved or improved with no worsening or appearance of new signs and symptoms; there is no requirement for additional antiviral of antibacterial therapy; chest roentgenograms (CT scans) are improved. The outcome is assessed in day 21 from the start of Study Drug treatment (visits 13).

  21 days

Secondary Outcomes (7)

• Early Clinical Response Rate

  72 hours (3 days) of study drug treatment

• Early Clinical Response Rate in pneumonia

  72 hours (3 days) of study drug treatment

• Percentage of clinically stable patients

  72 hours (3 days) of study drug treatment

• Survival rate

  21 days

• Clinical Status Change

  7 days

Study Arms (2)

Efesovir

EXPERIMENTAL

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.

Drug: Efesovir

Remdesivir

ACTIVE COMPARATOR

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.

Drug: Efesovir

Interventions

Efesovir DRUG

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.

Also known as: FS-1

Efesovir; Remdesivir

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scientific Center for Anti-infectious Drugs, Kazakhstan: lead

Study Sites (1)

Semey Medical University

Semey, East Kazakhstan, 071407, Kazakhstan

Location

Related Links

• Yuldasheva, G., R. Argirova and A. Ilin. "A quantum-chemical model of the inhibition HIV-1 integrase action by iodine complex compounds and lithium halogenides." Journal of AIDS and Clinical Research 6 (2015): 1-6. DOI:10.4172/2155-6113.1000465 Corpus
• Yuldasheva, G. , Zhidomirov, G. and Ilin, A. (2011) A quantum-chemical model of the inhibition mechanism of viral DNA HIV-1 replication by Iodine complexcompounds. Natural Science, 3, 573-579. doi: 10.4236/ns.2011.37080

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral

Interventions

pharmaceutical FS-1

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Marina Lankina, PhD

CONTACT

+77057064410; m-lankina@list.ru

Gulshara Akhmetova, PhD

CONTACT

+77085348842; akhmetovagk@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking, open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to the one of two parallel groups: 1) treated with study drug "Efesovir"; 2) treated with referent drug "Remdesivir".

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 29, 2021
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 2022
• Access Criteria: written request

Locations

KA (1)