- Alternative id - FK/FAV00А-CoV/2020
- Interventions - Drug: Enisamium Iodide|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Dept. Pulmonology, Lutsk, Volynsk, Ukraine|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, Ukraine|Municipal Non-Commercial Enterprise 'Regional Clinical Infection Hospital Ivano-Frankivsk Regional Council', Dept. #2, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine|Municipal Non-Commercial Enterprise 'Regional Clinical Hospital Ivano-Frankivsk Regional Council', Dept. Allergology, Ivano-Frankivsk, Ukraine|Municipal Non-Commercial Enterprise 'City Clinical Hospital #1 Ivano-Frankivsk City Council', Dept. Therapeutics, Ivano-Frankivsk, Ukraine|Municipal Non-Commercial Enterprise Kharkiv Regional Council 'Regional Clinical Infection Hospital', 1st Department, Kharkiv National Medical University, Chair of Infectious Diseases, Kharkiv, Ukraine|Municipal Non-Commercial Enterprise 'Olexandrivska Clinical Hospital of Kyiv' Executive Authority of Kyiv City Council, Dept. Infections, Kyiv, Ukraine|Municipal Non-Commercial Enterprise "Kyiv City Clinical Hospital #9" Executive Authority of Kyiv City Council, Dept. Infections, Kyiv, Ukraine|Municipal Non-Commercial Enterprise Lviv Regional Council 'Lviv Regional Infection Hospital', Fourth Diagnostic Department, Lviv, Ukraine|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, Ukraine|Municipal Non-Commercial Enterprise 'Central Clinical Hospital' of Rivne City Council, Hepatic Centre - Infections, Rivne, Ukraine|Municipal Non-Commercial Enterprise 'Regional Clinical Infectional Hospital' Transcarpathian Regional Council, Dept. Infections (Adult), Uzhhorod, Ukraine|Municipal Non-Сommercial Enterprise 'Vinnytsya City Clinical Hospital #1', Infectious Department, National Pirogov Memorial Medical University, Dept. Infections, Vinnytsya, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 592
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - 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|Efficacy - Time to recovery (TTR) from Day 1 (randomization and start of IMP treatment)|Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge|Sum of Severity Rating from Day 2 to Day 15 (SSR-15)|Severity Rating on Day 15 (SR-15):|Days Alive and Out of Hospital until Day 15 (DAOH-14)|Proportion of Subjects Discharged by Day 8, 15, 22, 29|Incidence of non-invasive ventilation|Days until non-invasive ventilation|Total days of non-invasive ventilation|Incidence of invasive mechanical ventilation or ECMO|Days until invasive mechanical ventilation or ECMO|Course of qualitative RT-PCR viral test results|Viral test evaluation - Proportion of subjects free of SARS-CoV-2|Overall assessment of efficacy (patient and investigator)|Adverse events (AEs)|Overall assessment of tolerability of treatment (patient and investigator)
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