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Efficacy and Safety Study of Essential Oil-Based Preparation Administered to COVID-19 Patients
Sponsor: Biodex S.A
Summary
The aim of this study was to compare the efficacy and safety of the essential oil-based product in patients with mild to moderate symptomatic COVID-19 Positive infection confirmed by PCR. A computational simulation approach of the molecular interaction (binding) of the main components of essential oils exhibiting antiviral activity with known intracellular protein targets of SARS-CoV-2 (nsp5: Main Protease) was adopted as a rationale for this study. SARS-CoV-2, a single-stranded RNA virus, has four major structural proteins Spike (S), Membrane (M), Envelope glycoprotein (E) and Nucleocapsid (N) protein and non-structural proteins (nsp). These non-structural proteins, of which there are 16 in total in the genome of the virus, play key roles in the mechanisms of the virus life cycle, including replication, transcription, protein synthesis and modification of RNA. Main protease (Main protease, Mpro, 3CLpro), virus Since they are directly involved in the maturation of these nsp proteins, which have an important role in many mechanisms of the life cycle, they have been the target enzyme in the development of new antiviral drugs for the treatment of COVID-19. In this study, our main rationale is to investigate the effect of essential oils on nsp5: Main Protease enzyme activations.
Official title: A Multicentre, Randomised, Prospective Study Investigating the Efficacy and Safety of an Essential Oil-Based Preparation Administered to Mild and Moderately Severe COVID-19 Positive Patients
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2024-09-15
Completion Date
2025-09-15
Last Updated
2024-06-13
Healthy Volunteers
No
Conditions
Interventions
IMMUNO19
280 participants will be divided into 2 groups. There will be 140 participants in the groups. The 1st group will receive IMMUNO19 10 mL one time, The 2nd group will receive Placebo 10 mL for one time.
Locations (10)
Bağcılar Training and Research Hospital
Istanbul, Bagcılar, Turkey (Türkiye)
Gaziosmanpaşa Training and Research Hospital
Istanbul, Gaziosmanpaşa, Turkey (Türkiye)
Kocaeli City Hospital
Kocaeli, İzmit, Turkey (Türkiye)
Göztepe Süleyman Yalçın City Hospital
Istanbul, Kadıköy, Turkey (Türkiye)
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Kartal, Turkey (Türkiye)
Akdeniz University
Antalya, Konyaaltı, Turkey (Türkiye)
Süreyyapaşa Chest Disease and Thoracic Surgery Training and Research Hospital
Istanbul, Maltepe, Turkey (Türkiye)
Umraniye Training and Research Hospital
Istanbul, Umraniye, Turkey (Türkiye)
Antalya Atatürk Public Hospital
Antalya, Turkey (Türkiye)
Cemil Taşcıoğlu City Hospital
Istanbul, Şişli, Turkey (Türkiye)