Efficacy and Safety Study of Essential Oil-Based Preparation Administered to COVID-19 Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiodex S.A

About this trial

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.

Eligibility criteria

Qualifiers

Patients must be between 18<X< 65 years of age.

The participant must be willing and able to give written informed consent. The volunteer must provide his/her consent on his or her behalf, a legally acceptable representative (i.e., an International Harmonization Council [ICH] and adopted by local law as appropriate can be used) must give informed consent on his/her behalf.

PCR test COVID-19 positive diagnosis and mild to moderate disease stage is required.

The participant must agree not to receive vaccines administered for COVID-19 during the study.

Disqualifiers

Patients < 18 years of age,

Positive diagnosis of severe COVID-19 with symptoms of basic severity: patients with respiratory distress, signs of mental confusion and impaired consciousness that develop depending on the severity of the stage of the disease,

Patients on active antiviral therapy,

Patients with creatine clearance < 30 ml/min and renal impairment,

Trial design

Treatments tested in this trial

  • IMMUNO19

Treatment groups

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Biodex S.A

Lead sponsor

Gama CRO Tıbbi IIac Arastirma Org.Tic.Ltd.Sti

Collaborator