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

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 2

Locations

Kazakhstan

Study Type

Interventional

Intervention

Efesovir

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, viral pneumonia, FS-1, Efesovir

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Semey Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Efesovir

Remdesivir

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Early Clinical Response Rate

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.

Early Clinical Response Rate in pneumonia

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.

Percentage of clinically stable patients

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.

Survival rate

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)).

Clinical Status Change

The clinical status is determined by the ordinal scale: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities and/or requiring home oxygen Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care Hospitalized, requiring supplemental oxygen Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation 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.

Adverse Events (AE)

The safety of Study Drug (Referent Drug) will be assessed by adverse event and serious adverse event monitoring.

Thyroid gland function

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)).

Full Information

NCT ID

NCT05060705

First Posted

September 24, 2021

Last Updated

April 25, 2023

Sponsor

Scientific Center for Anti-infectious Drugs, Kazakhstan

1. Study Identification

Unique Protocol Identification Number

NCT05060705

Brief Title

"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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Scientific Center for Anti-infectious Drugs, Kazakhstan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

COVID19, viral pneumonia, FS-1, Efesovir

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Efesovir

Arm Type

Experimental

Arm 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.

Arm Title

Remdesivir

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Efesovir

Other Intervention Name(s)

FS-1

Intervention Description

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 Measure Information:

Title

Clinical Response Rate

Description

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).

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Early Clinical Response Rate

Description

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.

Time Frame

72 hours (3 days) of study drug treatment

Title

Early Clinical Response Rate in pneumonia

Description

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.

Time Frame

72 hours (3 days) of study drug treatment

Title

Percentage of clinically stable patients

Description

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.

Time Frame

72 hours (3 days) of study drug treatment

Title

Survival rate

Description

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)).

Time Frame

21 days

Title

Clinical Status Change

Description

The clinical status is determined by the ordinal scale: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities and/or requiring home oxygen Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care Hospitalized, requiring supplemental oxygen Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation 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.

Time Frame

7 days

Title

Adverse Events (AE)

Description

The safety of Study Drug (Referent Drug) will be assessed by adverse event and serious adverse event monitoring.

Time Frame

up to 21 days

Title

Thyroid gland function

Description

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)).

Time Frame

Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marina Lankina, PhD

Phone

+77057064410

Email

m-lankina@list.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Gulshara Akhmetova, PhD

Phone

+77085348842

Email

akhmetovagk@yandex.ru

Facility Information:

Facility Name

Semey Medical University

City

Semey

State/Province

East-Kazakhstan Region

ZIP/Postal Code

071407

Country

Kazakhstan

Facility Contact: