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

NCT04682873 | Completed Phase 3

• 1 other identifier: FK/FAV00А-CoV/2020
• Study Type: interventional
• Target: 592
• Locations: 1 country
• Sites: 13

Brief 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. 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.

Conditions

Covid-19 Disease

Keywords

Amizon; Antiviral; Covid-19; Enisamium iodide; Ukraine; FAV00A

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Day 0 to Day 29

Secondary Outcomes (16)

• Efficacy - Time to recovery (TTR) from Day 1 (randomization and start of IMP treatment)

  Day 0 to Day 29

• Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge

  Day 0 to Day 29

• Sum of Severity Rating from Day 2 to Day 15 (SSR-15)

  Day 2 to Day 15

• Severity Rating on Day 15 (SR-15):

  Day 15 or Day of discharge (whichever occurs first)

• Days Alive and Out of Hospital until Day 15 (DAOH-14)

  Day 2 to Day 15

Study Arms (2)

Enisamium iodide

EXPERIMENTAL

Hospitalized patients who were randomized in to this treatment group will receive enisamium iodide containing capsules (Amizon® Max).

Drug: Enisamium Iodide

Placebo

PLACEBO COMPARATOR

Hospitalized patients who were randomized in to this treatment group will receive placebo containing capsules.

Drug: Placebo

Interventions

Enisamium Iodide DRUG

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.

Also known as: Amizon, Amizon® Max

Enisamium iodide

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Expected survival time \< 72 hours for any reason
• Positive pregnancy test
• Breastfeeding woman
• 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

Sponsors & Collaborators

• Joint Stock Company "Farmak": lead

Study Sites (13)

Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Dept. Pulmonology

Lutsk, Volynsk, 43024, Ukraine

Location

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, Ukraine

Location

Municipal Non-Commercial Enterprise 'Regional Clinical Infection Hospital Ivano-Frankivsk Regional Council', Dept. #2, Ivano-Frankivsk National Medical University

Ivano-Frankivsk, 76007, Ukraine

Location

Municipal Non-Commercial Enterprise 'Regional Clinical Hospital Ivano-Frankivsk Regional Council', Dept. Allergology

Ivano-Frankivsk, 76008, Ukraine

Location

Municipal Non-Commercial Enterprise 'City Clinical Hospital #1 Ivano-Frankivsk City Council', Dept. Therapeutics

Ivano-Frankivsk, 76018, Ukraine

Location

Municipal Non-Commercial Enterprise Kharkiv Regional Council 'Regional Clinical Infection Hospital', 1st Department, Kharkiv National Medical University, Chair of Infectious Diseases

Kharkiv, 61096, Ukraine

Location

Municipal Non-Commercial Enterprise 'Olexandrivska Clinical Hospital of Kyiv' Executive Authority of Kyiv City Council, Dept. Infections

Kyiv, 01601, Ukraine

Location

Municipal Non-Commercial Enterprise "Kyiv City Clinical Hospital #9" Executive Authority of Kyiv City Council, Dept. Infections

Kyiv, 04112,, Ukraine

Location

Municipal Non-Commercial Enterprise Lviv Regional Council 'Lviv Regional Infection Hospital', Fourth Diagnostic Department

Lviv, 79010, Ukraine

Location

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, Ukraine

Location

Municipal Non-Commercial Enterprise 'Central Clinical Hospital' of Rivne City Council, Hepatic Centre - Infections

Rivne, 33018, Ukraine

Location

Municipal Non-Commercial Enterprise 'Regional Clinical Infectional Hospital' Transcarpathian Regional Council, Dept. Infections (Adult)

Uzhhorod, 88017, Ukraine

Location

Municipal Non-Сommercial Enterprise 'Vinnytsya City Clinical Hospital #1', Infectious Department, National Pirogov Memorial Medical University, Dept. Infections

Vinnytsia, 21021, Ukraine

Location

MeSH Terms

Conditions

COVID-19

Interventions

enisamium iodide

Condition Hierarchy (Ancestors)

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

Study Officials

• Olha Holubovska, MD, DSc

  Head of Department of Infectious Diseases; O.O. Bogomolets National Medical University; Kyiv Ukraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Capsule formulations of the placebo Amizon® Max (IMP-2) is identical in appearance (size, shape, and color), taste, and smell as the active drug capsule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 24, 2020
• Study Start: May 15, 2020
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

UA (13)