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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05060705
Recruitment Status : Not yet recruiting
First Posted : September 29, 2021
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
Scientific Center for Anti-infectious Drugs, Kazakhstan

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".


Condition or disease Intervention/treatment Phase
Covid19 Drug: Efesovir Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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".
Masking: None (Open Label)
Masking Description: no masking, open label
Primary Purpose: Treatment
Official Title: Randomized Controlled Open Study of Safety and Preliminary Efficiency of the Drug "Efesovir" (Oral Solution) for Coronavirus Infection (COVID-19)
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Efesovir
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
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

Active Comparator: Remdesivir
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
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




Primary Outcome Measures :
  1. Clinical Response Rate [ Time Frame: 21 days ]

    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).



Secondary Outcome Measures :
  1. Early Clinical Response Rate [ Time Frame: 72 hours (3 days) of study drug treatment ]
    Early clinical response rate defined as complete resolution or significant improvement of at least 2 of 4 leading baseline signs and symptoms within 72 hours after the start of Study (Referent) Drug treatment. It is estimated in the Intent to Treat (ITT) population. The outcome is measured in percents.

  2. Early Clinical Response Rate in pneumonia [ Time Frame: 72 hours (3 days) of study drug treatment ]
    The outcome is estimated in patients with pneumonia due to coronavirus infection (modified ITT population). It is defined as complete resolution or significant improvement of at least 2 of 4 main clinical symptoms of pneumonia (cough, shortness of breath, chest pain, sputum) within 72 hours after the start of Study (or Referent) Drug treatment. The outcome is measured in percents. The percentage of subjects with an early clinical response to pneumonia in the compared groups is statistically estimated.

  3. Percentage of clinically stable patients [ Time Frame: 72 hours (3 days) of study drug treatment ]

    Percentage of patients at Day 3 who are clinically stable.

    Clinical stability defined as:

    • Blood oxygen saturation >= 93%
    • Temperature <=38.0°C
    • Heart rate <=100 beats per minute
    • Respiratory rate <=25 per minute
    • Systolic blood pressure ≥90 mm Hg
    • Ability to maintain oral intake
    • Normal mental status (oriented to person, place or time) A patient is considered to be clinically stable if all stability criteria are met. The outcome is assessed in ITT population. The difference between groups in the percentage of clinically stable patients from the total number of study subjects in the group is statistically evaluated.

  4. Survival rate [ Time Frame: 21 days ]

    Percentage of participants surviving at day 21. The indicator is calculated as the number of live subjects at the last visit (day 21) divided by the total number of study subjects in the group multiplied by 100.

    The outcome is estimated among subjects who completed the study in compliance with the protocol (per protocol population (PPP)).


  5. Clinical Status Change [ Time Frame: 7 days ]

    The clinical status is determined by the ordinal scale:

    1. Not hospitalized, no limitations on activities
    2. Not hospitalized, limitation on activities and/or requiring home oxygen
    3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
    4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
    5. Hospitalized, requiring supplemental oxygen
    6. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    7. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation
    8. Death

    Clinical status is assessed in ITT population. The outcome is recorded at all visits, starting from the day of randomization. A decrease in points indicates the effectiveness of treatment. When the indicator changes during the day, the worst score of the day is recorded. Statistical analysis is performed on the Day 7 from the start Study Drug treatment, comparing with the score at randomization.


  6. Adverse Events (AE) [ Time Frame: up to 21 days ]
    The safety of Study Drug (Referent Drug) will be assessed by adverse event and serious adverse event monitoring.

  7. Thyroid gland function [ Time Frame: Day 21 ]
    Changes in laboratory parameters of thyroid gland function (hormones) at the last visit in comparison with the baseline data (thyroid stimulating hormone (TSH), free triiodothyronine (FT3)).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05060705


Contacts
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Contact: Marina Lankina, PhD +77057064410 m-lankina@list.ru
Contact: Gulshara Akhmetova, PhD +77085348842 akhmetovagk@yandex.ru

Locations
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Kazakhstan
Semey Medical University
Semey, East-Kazakhstan Region, Kazakhstan, 071407
Contact: Asel Zh Baibusinova, PhD    +7 (702)725-07-96    assel.baibussinova@nao-mus.kz   
Contact: Maukaeva B Saule, PhD    +7(7052)-529-66-75    saule.maukayeva@nao-mus.kz   
Principal Investigator: Raikhan E Tuleutaeva, kandidate of medical science         
Sub-Investigator: Asel Zh Baibusinova, PhD         
Sub-Investigator: Saule B Maukaeva, PhD         
Sponsors and Collaborators
Scientific Center for Anti-infectious Drugs, Kazakhstan
Additional Information:
Study Data/Documents: thesis of online seminar  This link exits the ClinicalTrials.gov site
Gulnara A Yuldasheva and A I Ilin Inhibition of the catalytic fragment of the ExoN domain of the exoribonuclease of SARS-CoV-2-betacoronavirus B virus by FS-1 drug containing molecular iodine and lithium and magnesium halides International conference on infectious diseases, Infectious Diseases Prevention, Control and Cure, August 27 - 28, 2020 online seminar

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Responsible Party: Scientific Center for Anti-infectious Drugs, Kazakhstan
ClinicalTrials.gov Identifier: NCT05060705    
Other Study ID Numbers: CTP-FS-1-SE-2-05
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all individual participant Data (IPD )that underlie results in a publication
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 2022
Access Criteria: written request
URL: http://scaid.kz/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scientific Center for Anti-infectious Drugs, Kazakhstan:
COVID19
viral pneumonia
FS-1
Efesovir
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases