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

NCT06452069 | Not Yet Recruiting

• 1 other identifier: EC2021-ID19
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

COVID-19 Respiratory Infection; COVID-19

Keywords

Essential Oil, antiviral, Main Protease, COVID 19

Outcome Measures

Primary Outcomes (19)

• Clinical and virological cure rate in patients with PCR-confirmed mild to moderate symptomatic COVID-19 Positive infection treated with an essential oil-based product

  Day 0 Participant symptoms and quantitative PCR of viral load

  0th Day

• Clinical and virological cure rate in patients with PCR-confirmed mild to moderate symptomatic COVID-19 Positive infection treated with an essential oil-based product

  Day 2 Participant symptoms

  2nd Day

• Clinical and virological cure rate in patients with PCR-confirmed mild to moderate symptomatic COVID-19 Positive infection treated with an essential oil-based product

  Day 6 Participant symptoms and quantitative PCR of viral load

  6th Day

• Clinical and virological cure rate in patients with PCR-confirmed mild to moderate symptomatic COVID-19 Positive infection treated with an essential oil-based product

  Day 10 Participant symptoms and quantitative PCR of viral load

  10th Day

• TClinical and virological cure rate in patients with PCR-confirmed mild to moderate symptomatic COVID-19 Positive infection treated with an essential oil-based product.

  Day 20 Participant symptoms and quantitative PCR of viral load

  20th Day

• Clinical recovery defined by the absence of clinical signs of infection

  Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms

  0th Day

• Clinical recovery defined by the absence of clinical signs of infection

  Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms

  2nd Day

• Clinical recovery defined by the absence of clinical signs of infection

  Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms

  6th Day

• Clinical recovery defined by the absence of clinical signs of infection

  Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms

  10th Day

• Clinical recovery defined by the absence of clinical signs of infection

  Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms

  20th Day

• Aggravation of the clinical picture

  Appearance of a new sign that was not present at the beginning (not requiring hospitalization),Indicator of hospitalization during the study period,Hospitalization,Hospitalization with oxygen requirement,Hospitalization in intensive care, Death due to COVID-19

  0th Day

• Aggravation of the clinical picture

  Appearance of a new sign that was not present at the beginning (not requiring hospitalization),Indicator of hospitalization during the study period,Hospitalization,Hospitalization with oxygen requirement,Hospitalization in intensive care, Death due to COVID-19

  2nd Day

• Aggravation of the clinical picture

  Appearance of a new sign that was not present at the beginning (not requiring hospitalization),Indicator of hospitalization during the study period,Hospitalization,Hospitalization with oxygen requirement,Hospitalization in intensive care, Death due to COVID-19

  6th Day

• Aggravation of the clinical picture

  Appearance of a new sign that was not present at the beginning (not requiring hospitalization),Indicator of hospitalization during the study period,Hospitalization,Hospitalization with oxygen requirement,Hospitalization in intensive care, Death due to COVID-19

  10th Day

• Aggravation of the clinical picture

  Appearance of a new sign that was not present at the beginning (not requiring hospitalization),Indicator of hospitalization during the study period,Hospitalization,Hospitalization with oxygen requirement,Hospitalization in intensive care, Death due to COVID-19

  20th Day

• Virological evaluation

  Qualitative PCR Test and Quantitative PCR Test

  0th Day

• Virological evaluation

  Qualitative PCR Test and Quantitative PCR Test

  6th Day

• Virological evaluation

  Qualitative PCR Test and Quantitative PCR Test

  10th Day

• Virological evaluation

  Qualitative PCR Test and Quantitative PCR Test

  20th Day

Secondary Outcomes (9)

• Evaluation of time from inclusion to recovery in days

  0th Day

• Evaluation of time from inclusion to recovery in days

  6th Day

• Evaluation of time from inclusion to recovery in days

  10th Day

• Evaluation of time from inclusion to recovery in days

  20th Day

• Incidence of adverse events and serious advers event

  0th Day

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1: (n=140) Investigational Product 10 ml, drinkable ampoule (1 ampoule) (1 time only)

Other: IMMUNO19

Group 2

PLACEBO COMPARATOR

Group 2: (n=140) Placebo 10 ml (1 ampoule) (1 time only)

Other: IMMUNO19

Interventions

IMMUNO19 OTHER

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.

Also known as: Essential Oils Combination

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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,
• NYHA III-IV, Stage D heart failure patients requiring frequent hospitalization,
• Uncontrolled coagulopathy,
• Patients with advanced liver failure,
• Patients with active infections such as hepatitis B, hepatitis C and HIV, diseases requiring systemic treatment,
• Patients with active malignancy and known history of cancer,
• Those who do not have sufficient psychic state to disrupt working rounds,
• Active drug users,
• Known hypersensitivity and allergic reaction to the components of the preparation,
• Current participation in another interventional treatment study with an investigational agent,
• Recent use of the investigational product within 28 days of the first dose of the investigational product use or presence of a research device during screening,
• Pregnant or breastfeeding women,

Sponsors & Collaborators

• Biodex S.A: lead
• Gama CRO Tıbbi IIac Arastirma Org.Tic.Ltd.Sti: collaborator

Study Sites (10)

Bağcılar Training and Research Hospital

Istanbul, Bagcılar, 34212, Turkey (Türkiye)

Location

Gaziosmanpaşa Training and Research Hospital

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

Location

Kocaeli City Hospital

Kocaeli, İzmit, 41060, Turkey (Türkiye)

Location

Göztepe Süleyman Yalçın City Hospital

Istanbul, Kadıköy, 34722, Turkey (Türkiye)

Location

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

Süreyyapaşa Chest Disease and Thoracic Surgery Training and Research Hospital

Istanbul, Maltepe, 34844, Turkey (Türkiye)

Location

Umraniye Training and Research Hospital

Istanbul, Umraniye, 34764, Turkey (Türkiye)

Location

Antalya Atatürk Public Hospital

Antalya, 07040, Turkey (Türkiye)

Location

Cemil Taşcıoğlu City Hospital

Istanbul, Şişli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

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

• Kanat Tayfun, MD

  Bagcilar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mounir Bezzarga

CONTACT

+216 98 362260; mounir.bezzarga@yahoo.fr

İklim Turkoz

CONTACT

+90 543 259 59 40; iklim.turkoz@gamacro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Prospective Study

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 11, 2024
• Study Start: September 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: September 15, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

TU (10)