Covid-19 DiseasePhase 3NCT04682873
A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19, Caused by the SARS-CoV-2 Virus
A Phase 3 study testing Enisamium Iodide in people with Covid-19 Disease, run by Joint Stock Company "Farmak" at 13 sites in Ukraine.
Trial summary
Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this prospective, multi-center, double-blind, randomised, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid-19 Disease
- What is being tested?
- Enisamium Iodide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 592 participants
- Where
- 13 sitesUkraine
- Study dates
- 15 May 2020to 26 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject must meet all of the following inclusion criteria to be randomized to treatment:
- Willing and able to provide written informed consent
- Aged ≥ 18 years
- SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
- Currently hospitalized due to SARS-CoV-2 infection with fever, defined as body temperature ≥ 37.8 °C
- Modified World Health Organization (WHO) Ordinal Scale for Clinical Status Patient state in Covid-19: score 4 i.e. hospitalized, virus-positive, oxygen by mask or nasal prongs
Who cannot join
- The subject is excluded from the trial if any of the following criteria apply:
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to start of IMP treatment
- Requiring mechanical ventilation at screening or it is expected within 24 h after inclusion
- Expected survival time < 72 hours for any reason
- Positive pregnancy test
- Breastfeeding woman
Show all 10Show fewer
- Presence of renal dysfunction defined as estimated glomerular filtration rate (eGFR) <60 mL/min, total bilirubin ≥ 2.0 mg/dL, Thyroid stimulating hormone (TSH) outside normal range and / or Aspartate aminotransferase (ASAT)/ Alanine aminotransferase (ALAT) above threefold upper limit of normal range (known from patients medical history)
- Known hypersensitivity to the trial drug, the metabolites, or formulation excipient
- History or presence of drug or alcohol abuse
- History or presence of diseases of thyroid gland
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Ukraine13 sites
Municipal Non-Commercial Enterprise 'City Clinical Hospital #3' Chernivtsi City Council, Dept. Therapeutics #1, Dept. Therapeutics #2, Higher State Educational Institution of Ukraine 'Bukovinian State University'
Chernivtsi, 58002
Municipal Non-Commercial Enterprise 'Regional Clinical Infection Hospital Ivano-Frankivsk Regional Council', Dept. #2, Ivano-Frankivsk National Medical University
Ivano-Frankivsk, 76007
Municipal Non-Commercial Enterprise 'Regional Clinical Hospital Ivano-Frankivsk Regional Council', Dept. Allergology
Ivano-Frankivsk, 76008
Municipal Non-Commercial Enterprise 'City Clinical Hospital #1 Ivano-Frankivsk City Council', Dept. Therapeutics
Ivano-Frankivsk, 76018
Municipal Non-Commercial Enterprise Kharkiv Regional Council 'Regional Clinical Infection Hospital', 1st Department, Kharkiv National Medical University, Chair of Infectious Diseases
Kharkiv, 61096
Municipal Non-Commercial Enterprise 'Olexandrivska Clinical Hospital of Kyiv' Executive Authority of Kyiv City Council, Dept. Infections
Kyiv, 01601
Municipal Non-Commercial Enterprise "Kyiv City Clinical Hospital #9" Executive Authority of Kyiv City Council, Dept. Infections
Kyiv, 04112,
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Dept. Pulmonology
Lutsk, Volynsk, 43024
Municipal Non-Commercial Enterprise Lviv Regional Council 'Lviv Regional Infection Hospital', Fourth Diagnostic Department
Lviv, 79010
Ukraine Medical Stomatological Academy, Chair of Infectious Diseases with Epidemiology, Municipal Non-Commercial Enterprise 'Poltava Regional Infection Hospital Poltava Regional Council', Dept. Respiratory Infections
Poltava, 36011
Municipal Non-Commercial Enterprise 'Central Clinical Hospital' of Rivne City Council, Hepatic Centre - Infections
Rivne, 33018
Municipal Non-Commercial Enterprise 'Regional Clinical Infectional Hospital' Transcarpathian Regional Council, Dept. Infections (Adult)
Uzhhorod, 88017
Municipal Non-Сommercial Enterprise 'Vinnytsya City Clinical Hospital #1', Infectious Department, National Pirogov Memorial Medical University, Dept. Infections
Vinnytsia, 21021
About this study
Official title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Trial to Assess the Efficacy and Safety of Amizon® Max, Manufactured by Farmak JSC, in Combination With Basic Treatment, in Subjects With Moderate Covid-19, Which is Caused by the SARS-CoV-2 Virus
Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this prospective, multi-center, double-blind, randomised, placebo-controlled trial.
Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days; patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6 hours for 7 days. Patient observation and follow-up are planned for 29 days, unless discharged before Day 29.
Read more
The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an increase of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the study drug will be evaluated based on the intensity and course of adverse events (Es).
Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral RNA polymerase.
Read the detailed description
This randomized, prospective, multi-center, double-blind, placebo-controlled trial, is conducted to investigate the clinical efficacy and safety of the drug Amizon® Max (N-methyl-4-benzylcarbamidopyridinium iodide, international nonproprietary name enisamium iodide, lab code FAV00A) in comparison with placebo, for the treatment of hospitalized patients with RT-PCR confirmed Covid-19 infection.
Enisamium iodide is an antiviral small molecule. Enisamium can directly inhibit influenza viral RNA replication and has antiviral effect against viruses, including coronaviruses (human coronavirus NL63, SARS-CoV-2).Based on the promising in-vitro anti-SARS-CoV-2 activity, it could be assumed that patients suffering from Covid-19 would benefit from a reduced virus load and this could lead to a reduction of Covid-19 typical symptoms that might prevent further complications associated with severe Covid-19 (e.g. active mechanical ventilation).
Adult female and male patients, with Covid-19 infection, will be screened (Day 1) to participate in this trial. If all inclusion/exclusion criteria are fulfilled, randomization to treatment and a start of treatment will occur on Day 1.
Patients will be randomized into 2 treatment groups (1:1) as follows: patients in treatment Group 1 will receive the active treatment with Amizon® Max capsule; patients in treatment Group 2 will receive a placebo capsule. The active treatment and placebo capsules are identical in appearance and size.
Patients will take Amizon® Max capsules 500 mg (active ingredient enisamium iodide) 4 times a day every 6 hours (total daily dose 2,000 mg) for full 7 days. In the control group, patients will take placebo tablets 4 times a day for full 7 days. Patient observation interval is for as long as a subject is hospitalized Day 1 to Day 29. A follow-up visit will be performed on Day 29 (by phone as applicable for all subjects discharged from the hospital before Day 29).
The effect of treatment on Covid-19 will be evaluated by the time from the day of randomization (Day 0) to an improvement of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15).
Additional outcome measures of efficacy include the 'Days Alive' and 'Out of Hospital' from Day 1 until Day 15 (DAOH-14), the proportion of subjects discharged by Day 8, 15, 22, and 29, the incidence of complications (i.e. pneumonia, need for transfer to intensive care unit [ICU]), the incidence and days until occurrence of pneumonia, incidence and days until supplemental oxygen / high flow oxygen, incidence and days until (non-invasive / invasive mechanical ventilation), incidence and days until transfer to ICU, incidence and time to death, time to virus free, measurement of vital signs (i.e. fever (body temperature), respiratory rate, peripheral capillary oxygen saturation [SpO2]) and the course of symptoms of Covid-19.
Symptom severity for headache, sore throat, cough, shortness of breath, rhinorrhoea, fatigue, myalgia, diarrhoea will be monitored. Safety and tolerability of the study drug will be evaluated based on the intensity and course of adverse events (AEs), safety laboratory tests, as well as the investigator's and subject's overall assessment of tolerability of the treatment.
- Conditions
- Covid-19 Disease
- Being tested
- Enisamium Iodide, Placebo
- Keywords
- Amizon, Antiviral, Covid-19, Enisamium iodide, Ukraine, FAV00A
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enisamium IodideDrug
Also called Amizon, Amizon® Max
Capsule formulations of the active product (enisamium iodide 500 mg; Investigational medicinal product 1 [IMP-1]).
1 capsule Amizon® Max contains: enisamium iodide 500 mg.
Amizon® Max (active ingredient: enisamium iodide; IMP-1 will be administered as 1 capsule 4 times a day, every 6 hours (total dose 2,000 mg per day). Capsule will be taken orally (swallowed whole), together with a sufficient amount of liquid (preferably water).
Treatment will start on Day 1 (randomization) and for up to 168 hours after the first dose administration i.e. Day 7 or Day 8. The site staff will ensure that the IMP (1 capsule) is taken every 6 hours by the study subjects.
For documentation purposes, the IMP-1 packs (empty blister / blister with unused capsules) will be kept at the site and drug accountability forms are completed.
PlaceboDrug
Capsule formulations of the reference product placebo Amizon® Max (IMP-2), will be identical in appearance (size, shape, and color), taste, and smell as the active formulation capsule.
1 capsule placebo Amizon® Max contains: placebo (no active substance).
Amizon® Max placebo (IMP-2), will be administered as 1 capsule 4 times a day every 6 hours. Capsule will be taken orally (swallowed whole), together with a sufficient amount of liquid (preferably water).
Treatment will start on Day 1 (randomization) and for up to 168 hours after the first dose administration i.e. Day 7 or Day 8. The site staff will ensure that the IMP (1 capsule) is taken every 6 hours by the study subjects.
For documentation purposes, the IMP-2 packs (empty blister / blister with unused capsules) will be kept at the site and drug accountability forms are completed.
| Study group | Role | What they receive |
|---|---|---|
| Enisamium iodide | Experimental | Hospitalized patients who were randomized in to this treatment group will receive enisamium iodide containing capsules (Amizon® Max). Receives: Drug: Enisamium Iodide |
| Placebo | Placebo comparator | Hospitalized patients who were randomized in to this treatment group will receive placebo containing capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Time from day of randomization to an improvement of at least two points (from the status at randomization) on severity rating (SR) scale in days
Time from day of randomization to an increase of at least two points (from the status at randomization) on the following severity rating (SR) scale in days:
- - Death
- - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- - Hospitalized, on non-invasive ventilation or high flow oxygen devices
- - Hospitalized, requiring supplemental oxygen
- - Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise)
- - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- - Not hospitalized, limitation on activities and/or requiring home oxygen
- - Not hospitalized, no limitations on activities
Measured: Day 0 to Day 29
Secondary outcomes (16)
Efficacy - Time to recovery (TTR) from Day 1 (randomization and start of IMP treatment)
Time to recovery (TTR) from day of randomisation: Day of recovery is defined as the first day on which the subject satisfies one of the following 3 categories from the ordinal scale (same scale being used as for the primary endpoint):
6 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7 - Not hospitalized, limitation on activities and/or requiring home oxygen 8 - Not hospitalized, no limitations on activities
Measured: Day 0 to Day 29
Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge
Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge, whichever comes first: TTCR is defined as the time (Days) from randomisation (active or placebo) until normalization of fever, respiratory rate, oxygen saturation, and cough, sustained for at least 48 hours. Normalization and alleviation criteria:
- Fever ≤37.2°C
- Respiratory rate - ≤24/minute on room air
- Oxygen saturation - >94% on room air
- Cough: absent
Measured: Day 0 to Day 29
Sum of Severity Rating from Day 2 to Day 15 (SSR-15)
Sum of Severity Rating from Day 2 to Day 15 (SSR-15): Daily reporting of severity rating on an 8-point ordinal scale. The ordinal scale is an assessment of the clinical status starting from initiation of study treatment (active or placebo) from Day 2 to Day 15. The scale from 1 to 8 as defined for the primary endpoint.
Measured: Day 2 to Day 15
Severity Rating on Day 15 (SR-15):
Severity Rating on Day 15 (SR-15): Reporting of severity rating on Day 15 or Day of discharge whichever occurs first on an 8-point ordinal scale. The ordinal scale is an assessment of the clinical status. The scale is defined from 1 (Death) to 8 (Not hospitalized, no limitations on activities) as defined for the primary endpoint.
Measured: Day 15 or Day of discharge (whichever occurs first)
Days Alive and Out of Hospital until Day 15 (DAOH-14)
The number of days alive and discharged from hospital until day 15 will be calculated for each group and the treatment differences displayed.
Measured: Day 2 to Day 15
Proportion of Subjects Discharged by Day 8, 15, 22, 29
The proportion of subjects discharged by Day 8, 15, 22 and 29 will be displayed for the two treatment groups.
Measured: Day 0 to Day 29
Incidence of non-invasive ventilation
The analysis of the incidences of non-invasive ventilation will be performed by logistic regression model with the binary outcome as dependent variable, age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors.
Measured: Day 0 to Day 29
Days until non-invasive ventilation
The days until non-invasive ventilation will be calculated and the treatment differences displayed using the stratified log-rank test.
Measured: Day 0 to Day 29
Total days of non-invasive ventilation
The total days of non-invasive ventilation will be evaluated by the generalized linear model based on the Poisson distribution and including age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors into the model.
Measured: Day 0 to Day 29
Incidence of invasive mechanical ventilation or ECMO
The analysis of the incidence rate of invasive mechanical ventilation will be performed by logistic regression model with the binary outcome as dependent variable, age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors.
Measured: Day 0 to Day 29
Days until invasive mechanical ventilation or ECMO
The days until invasive mechanical ventilation or ECMO will be calculated and the treatment differences displayed using the stratified log-rank test.
Measured: Day 0 to Day 29
Course of qualitative RT-PCR viral test results
The course of qualitative RT-PCR virus test results will be evaluated by logistic regression with virus test as dependent variable, age as covariate, baseline severity rating, day, centre, treatment as fixed factors. In addition the interaction terms treatment x day and treatment x centre will be included as interaction term as fixed effect into the model. The treatment x day interaction term should detect any differences between treatments in the time until virus deletion.
Measured: Day 0 to Day 29
Viral test evaluation - Proportion of subjects free of SARS-CoV-2
Proportion of subjects SARS-CoV-2 free pharyngeal swabs / sputum samples (virus-free) on Days 8, 15, 22, 29
Measured: Days 0, 8, 15, 22, 29
Overall assessment of efficacy (patient and investigator)
The investigator and the subject (each separately) will assess the overall (global) efficacy of the IMP, based on the change in symptoms using a Four-point verbal rating scale (VRS-4) (0=no symptoms / cured, 1=symptoms improved compared to Visit 1, 2=symptoms unchanged compared to Visit 1, 3=symptoms deteriorated compared to Visit 1).
Measured: Day 29 or Day of discharge (whichever occurs first)
Adverse events (AEs)
Evaluate AEs by time of onset, actions taken, pattern of occurrence, and outcome
Measured: Day 0 to Day 29
Overall assessment of tolerability of treatment (patient and investigator)
Difference in the global tolerability judgement scores on Day of Discharge from hospital (or Day 29, end of trial, if not discharged earlier).
The investigator and the subject (each separately) will assess the overall (global) tolerability of the IMP using a five-point rating scale (0=very good, 1=good, 2=moderate, 3=poor, 4=very poor).
Measured: Day 29 or Day of discharge (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start15 May 2020
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Stock Company "Farmak"
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olha Holubovska, MD, DSc, Principal investigator, Head of Department of Infectious Diseases; O.O. Bogomolets National Medical University; Kyiv Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682873
- Sponsor's protocol ID
- FK/FAV00А-CoV/2020
- Status last verified
- Nov 2021
- First submitted
- 22 Dec 2020
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Double-blind, Randomised, Placebo-controlled, Trial to Assess the Efficacy and Safety of Amizon® Max, Manufactured by Farmak JSC, in Combination With Basic Treatment, in Subjects With Moderate Covid-19, Which is Caused by the SARS-CoV-2 Virus
- ClinicalTrials.gov ID
- NCT04682873
- Acronym / sponsor ID
- FK/FAV00А-CoV/2020
- Conditions
- Covid-19 Disease
- Keywords
- Amizon, Antiviral, Covid-19, Enisamium iodide, Ukraine, FAV00A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Joint Stock Company "Farmak"Industry (pharma, biotech, devices)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 24 Dec 2020 (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.
Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this prospective, multi-center, double-blind, randomised, placebo-controlled trial.
Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days; patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6 hours for 7 days. Patient observation and follow-up are planned for 29 days, unless discharged before Day 29.
The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an increase of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the study drug will be evaluated based on the intensity and course of adverse events (Es).
Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral RNA polymerase.
Detailed description
This randomized, prospective, multi-center, double-blind, placebo-controlled trial, is conducted to investigate the clinical efficacy and safety of the drug Amizon® Max (N-methyl-4-benzylcarbamidopyridinium iodide, international nonproprietary name enisamium iodide, lab code FAV00A) in comparison with placebo, for the treatment of hospitalized patients with RT-PCR confirmed Covid-19 infection.
Enisamium iodide is an antiviral small molecule. Enisamium can directly inhibit influenza viral RNA replication and has antiviral effect against viruses, including coronaviruses (human coronavirus NL63, SARS-CoV-2).Based on the promising in-vitro anti-SARS-CoV-2 activity, it could be assumed that patients suffering from Covid-19 would benefit from a reduced virus load and this could lead to a reduction of Covid-19 typical symptoms that might prevent further complications associated with severe Covid-19 (e.g. active mechanical ventilation).
Adult female and male patients, with Covid-19 infection, will be screened (Day 1) to participate in this trial. If all inclusion/exclusion criteria are fulfilled, randomization to treatment and a start of treatment will occur on Day 1.
Patients will be randomized into 2 treatment groups (1:1) as follows: patients in treatment Group 1 will receive the active treatment with Amizon® Max capsule; patients in treatment Group 2 will receive a placebo capsule. The active treatment and placebo capsules are identical in appearance and size.
Patients will take Amizon® Max capsules 500 mg (active ingredient enisamium iodide) 4 times a day every 6 hours (total daily dose 2,000 mg) for full 7 days. In the control group, patients will take placebo tablets 4 times a day for full 7 days. Patient observation interval is for as long as a subject is hospitalized Day 1 to Day 29. A follow-up visit will be performed on Day 29 (by phone as applicable for all subjects discharged from the hospital before Day 29).
The effect of treatment on Covid-19 will be evaluated by the time from the day of randomization (Day 0) to an improvement of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15).
Additional outcome measures of efficacy include the 'Days Alive' and 'Out of Hospital' from Day 1 until Day 15 (DAOH-14), the proportion of subjects discharged by Day 8, 15, 22, and 29, the incidence of complications (i.e. pneumonia, need for transfer to intensive care unit [ICU]), the incidence and days until occurrence of pneumonia, incidence and days until supplemental oxygen / high flow oxygen, incidence and days until (non-invasive / invasive mechanical ventilation), incidence and days until transfer to ICU, incidence and time to death, time to virus free, measurement of vital signs (i.e. fever (body temperature), respiratory rate, peripheral capillary oxygen saturation [SpO2]) and the course of symptoms of Covid-19.
Symptom severity for headache, sore throat, cough, shortness of breath, rhinorrhoea, fatigue, myalgia, diarrhoea will be monitored. Safety and tolerability of the study drug will be evaluated based on the intensity and course of adverse events (AEs), safety laboratory tests, as well as the investigator's and subject's overall assessment of tolerability of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enisamium iodide | Experimental | Drug: Enisamium IodideHospitalized patients who were randomized in to this treatment group will receive enisamium iodide containing capsules (Amizon® Max). |
| Placebo | Placebo comparator | Drug: PlaceboHospitalized patients who were randomized in to this treatment group will receive placebo containing capsules. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Each subject must meet all of the following inclusion criteria to be randomized to treatment:
- Willing and able to provide written informed consent
- Aged ≥ 18 years
- SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
- Currently hospitalized due to SARS-CoV-2 infection with fever, defined as body temperature ≥ 37.8 °C
Key exclusion criteria (10 listed)
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to start of IMP treatment
- Requiring mechanical ventilation at screening or it is expected within 24 h after inclusion
- Expected survival time < 72 hours for any reason
- Positive pregnancy test
- Breastfeeding woman
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 |
|---|---|---|
| Enisamium IodideAlso: Amizon, Amizon® MaxCapsule formulations of the active product (enisamium iodide 500 mg; Investigational medicinal product 1 [IMP-1]). 1 capsule Amizon® Max contains: enisamium iodide 500 mg. Amizon® Max (active ingredient: enisamium iodide; IMP-1 will be administered as 1 capsule 4 times a day, every 6 hours (total dose 2,000 mg per day). Capsule will be taken orally (swallowed whole), together with a sufficient amount of liquid (preferably water). Treatment will start on Day 1 (randomization) and for up to 168 hours after the first dose administration i.e. Day 7 or Day 8. The site staff will ensure that the IMP (1 capsule) is taken every 6 hours by the study subjects. For documentation purposes, the IMP-1 packs (empty blister / blister with unused capsules) will be kept at the site and drug accountability forms are completed. | Drug | Enisamium iodide |
| PlaceboCapsule formulations of the reference product placebo Amizon® Max (IMP-2), will be identical in appearance (size, shape, and color), taste, and smell as the active formulation capsule. 1 capsule placebo Amizon® Max contains: placebo (no active substance). Amizon® Max placebo (IMP-2), will be administered as 1 capsule 4 times a day every 6 hours. Capsule will be taken orally (swallowed whole), together with a sufficient amount of liquid (preferably water). Treatment will start on Day 1 (randomization) and for up to 168 hours after the first dose administration i.e. Day 7 or Day 8. The site staff will ensure that the IMP (1 capsule) is taken every 6 hours by the study subjects. For documentation purposes, the IMP-2 packs (empty blister / blister with unused capsules) will be kept at the site and drug accountability forms are completed. | Drug | Placebo |
Primary outcome
Efficacy - Time from day of randomization to an improvement of at least two points (from the status at randomization) on severity rating (SR) scale in days
Time frame: Day 0 to Day 29
Time from day of randomization to an increase of at least two points (from the status at randomization) on the following severity rating (SR) scale in days: 1. - Death 2. - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. - Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. - Hospitalized, requiring supplemental oxygen 5. - Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise) 6. - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. - Not hospitalized, limitation on activities and/or requiring home oxygen 8. - Not hospitalized, no limitations on activities
16 secondary outcomes
Efficacy - Time to recovery (TTR) from Day 1 (randomization and start of IMP treatment)
Time frame: Day 0 to Day 29
Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge
Time frame: Day 0 to Day 29
Sum of Severity Rating from Day 2 to Day 15 (SSR-15)
Time frame: Day 2 to Day 15
Severity Rating on Day 15 (SR-15):
Time frame: Day 15 or Day of discharge (whichever occurs first)
Days Alive and Out of Hospital until Day 15 (DAOH-14)
Time frame: Day 2 to Day 15
Proportion of Subjects Discharged by Day 8, 15, 22, 29
Time frame: Day 0 to Day 29
Incidence of non-invasive ventilation
Time frame: Day 0 to Day 29
Days until non-invasive ventilation
Time frame: Day 0 to Day 29
Total days of non-invasive ventilation
Time frame: Day 0 to Day 29
Incidence of invasive mechanical ventilation or ECMO
Time frame: Day 0 to Day 29
Days until invasive mechanical ventilation or ECMO
Time frame: Day 0 to Day 29
Course of qualitative RT-PCR viral test results
Time frame: Day 0 to Day 29
Viral test evaluation - Proportion of subjects free of SARS-CoV-2
Time frame: Days 0, 8, 15, 22, 29
Overall assessment of efficacy (patient and investigator)
Time frame: Day 29 or Day of discharge (whichever occurs first)
Adverse events (AEs)
Time frame: Day 0 to Day 29
Overall assessment of tolerability of treatment (patient and investigator)
Time frame: Day 29 or Day of discharge (whichever occurs first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Olha Holubovska, MD, DSc principal investigator
Head of Department of Infectious Diseases; O.O. Bogomolets National Medical University; Kyiv Ukraine
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enisamium Iodide in people with Covid-19 Disease, run by Joint Stock Company "Farmak" at 13 sites in Ukraine.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Ukraine. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Time from day of randomization to an improvement of at least two points (from the status at randomization) on severity rating (SR) scale in days (time frame: Day 0 to Day 29). 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 29 Dec 2021.