Covid19Phase 2NCT05060705
"Efesovir" (FS-1) for COVID-19, Phase 2
A Phase 2 study testing Efesovir in people with Covid19, run by Scientific Center for Anti-infectious Drugs, Kazakhstan at 1 site in Kazakhstan.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Covid19
- What is being tested?
- Efesovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteKazakhstan
- Study dates
- Dec 2025to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site
Semey Medical University
Semey, East Kazakhstan, 071407
Asel Zh Baibusinova, PhD, +7 (702)725-07-96, assel.baibussinova@nao-mus.kz
Maukaeva B Saule, PhD, +7(7052)-529-66-75, saule.maukayeva@nao-mus.kz
About this study
Official title: Randomized Controlled Open Study of Safety and Preliminary Efficiency of the Drug "Efesovir" (Oral Solution) for Coronavirus Infection (COVID-19)
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
- Being tested
- Efesovir
- Keywords
- COVID19, viral pneumonia, FS-1, Efesovir
- Medical subject headings
- COVID-19, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfesovirDrug
Also called FS-1
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Efesovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 21 days
Secondary outcomes (7)
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.
Measured: 72 hours (3 days) of study drug treatment
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.
Measured: 72 hours (3 days) of study drug treatment
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.
Measured: 72 hours (3 days) of study drug treatment
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)).
Measured: 21 days
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.
Measured: 7 days
Adverse Events (AE)
The safety of Study Drug (Referent Drug) will be assessed by adverse event and serious adverse event monitoring.
Measured: up to 21 days
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)).
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study startDec 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060705
- Sponsor's protocol ID
- CTP-FS-1-SE-2-05
- Status last verified
- Apr 2024
- First submitted
- 24 Sep 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant Data (IPD )that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Open Study of Safety and Preliminary Efficiency of the Drug "Efesovir" (Oral Solution) for Coronavirus Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT05060705
- Acronym / sponsor ID
- CTP-FS-1-SE-2-05
- Conditions
- Covid19
- Keywords
- COVID19, viral pneumonia, FS-1, Efesovir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Scientific Center for Anti-infectious Drugs, KazakhstanIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to the one of two parallel groups: 1) treated with study drug "Efesovir"; 2) treated with referent drug "Remdesivir".
| Arm | Type | Receives |
|---|---|---|
| Efesovir | Experimental | Drug: EfesovirThe 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. |
| Remdesivir | Active comparator | Drug: EfesovirThe 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EfesovirAlso: FS-1Antiviral 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. | Drug | Efesovir, Remdesivir |
Primary outcome
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).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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 CorpusLink provided by the sponsor.
- 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.2011.37080Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. all individual participant Data (IPD )that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efesovir in people with Covid19, run by Scientific Center for Anti-infectious Drugs, Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Lankina, PhD (+77057064410, m-lankina@list.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response Rate (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.