Status:
COMPLETED
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
Lead Sponsor:
Joint Stock Company "Farmak"
Conditions:
Covid-19 Disease
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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, ...
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-benzylcarbamidopyri...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2021
Estimated Enrollment :
592 Patients enrolled
Trial Details
Trial ID
NCT04682873
Start Date
May 15 2020
End Date
March 26 2021
Last Update
December 29 2021
Active Locations (13)
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1
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Dept. Pulmonology
Lutsk, Volynsk, Ukraine, 43024
2
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, 58002
3
Municipal Non-Commercial Enterprise 'Regional Clinical Infection Hospital Ivano-Frankivsk Regional Council', Dept. #2, Ivano-Frankivsk National Medical University
Ivano-Frankivsk, Ukraine, 76007
4
Municipal Non-Commercial Enterprise 'Regional Clinical Hospital Ivano-Frankivsk Regional Council', Dept. Allergology
Ivano-Frankivsk, Ukraine, 76008