Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gama CRO Tıbbi IIac Arastirma Org.Tic.Ltd.Sti | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
The indiscriminate use of antimicrobial agents has led to the emergence of a number of drug-resistant bacteria, fungi and viruses. To overcome the increasing resistance of pathogenic microbes, more effective antimicrobial agents with new modes of action must be developed.
Medicinal plants used in traditional medicines to treat infectious diseases are an abundant source of new bioactive secondary metabolites. Therefore, in the last few years, various medicinal plants and plant extracts have been screened for their antimicrobial activities . Essential oils obtained from aromatic medicinal plants (e.g. fennel (Foeniculum vulgare), mint (Mentha piperita), thyme (Thymus vulgaris)) have been shown to have antimicrobial activity against gram-positive and gram-negative bacteria as well as yeasts, It has been reported to be active against fungi and viruses. They are mixtures of different lipophilic and volatile substances such as monoterpenes, sesquiterpenes and/or phenylpropanoids and have a pleasant odour. They are also part of the pre-formed defence system of higher plants are thought to be . Monoterpenes have been widely studied, especially for their antiviral properties.
Nowadays, the use of essential oils is becoming increasingly widespread both in pharmacies and in various stores. The use of essential oils for therapeutic purposes is expanding. The molecules that make up certain essential oils have shown various antiviral properties:
Herbal products are an important source of herbal remedies and other medicines. Essential oils have shown various pharmacological activities, such as antiviral activity, and have therefore been implicated in SARS-CoV- It has been suggested to have potential activity against 2. Essential oils can easily penetrate the viral membrane due to their lipophilicity and can cause rupture of the viral membrane.
In addition, crude essential oils often have many active components that can act on different parts of the virus, including cell entry, translation, transcription and assembly. Anti-inflammatory, immune regulation on the respiratory system of the host, have other beneficial pharmacological effects, including bronchiectasis and mucolytics.
Essential oils have many advantages because they promise volatile antiviral molecules, making them useful either alone or in combination with other chemotherapeutic drugs, making them potential drug targets for the prevention and treatment of COVID-19.
In this study, 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: Master Protease) was adopted as a rationale. A single-chain.
The RNA virus SARS-CoV-2 has four main structural proteins Spike (S), Membrane (M), Envelope glycoprotein (E) and Nucleoapsid (N) proteins and non-structural proteins (nsp) .
These non-structural proteins, of which there are 16 in total in the genome of the virus, play a key role in the mechanisms of the virus life cycle, including replication, transcription, protein synthesis and modification of RNA. Main protease (Mpro, 3CLpro) has been the target enzyme for the development of new antiviral drugs for the treatment of COVID-19 , as they are directly involved in the maturation of these nsp proteins, which have an important role in many mechanisms of the virus life cycle. Our main rationale in this study is to investigate the effect of essential oils on nsp5: Main Protease enzyme activations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1: (n=140) Investigational Product 10 ml, drinkable ampoule (1 ampoule) (1 time only) |
|
| Group 2 | Placebo Comparator | Group 2: (n=140) Placebo 10 ml (1 ampoule) (1 time only) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of time from inclusion to recovery in days | Negative PCR and viral load | 0th Day |
| Evaluation of time from inclusion to recovery in days | Negative PCR and viral load |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mounir Bezzarga | Contact | +216 98 362260 | mounir.bezzarga@yahoo.fr | |
| İklim Turkoz | Contact | +90 543 259 59 40 | iklim.turkoz@gamacro.com |
| Name | Affiliation | Role |
|---|---|---|
| Kanat Tayfun, MD | Bagcilar Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bağcılar Training and Research Hospital | Istanbul | Bagcılar | 34212 | Turkey (Türkiye) | ||
| Gaziosmanpaşa Training and Research Hospital |
Not provided
Multicenter, Randomized, Prospective Study
Not provided
Not provided
Double Blind
|
| 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 |
| 6th Day |
| Evaluation of time from inclusion to recovery in days | Negative PCR and viral load | 10th Day |
| Evaluation of time from inclusion to recovery in days | Negative PCR and viral load | 20th Day |
| Incidence of adverse events and serious advers event | Collection of adverse events and serious adverse events | 0th Day |
| Incidence of adverse events and serious advers event | Collection of adverse events and serious adverse events | 2nd Day |
| Incidence of adverse events and serious advers event | Collection of adverse events and serious adverse events | 6th Day |
| Incidence of adverse events and serious advers event | Collection of adverse events and serious adverse events | 10th Day |
| Incidence of adverse events and serious advers event | Collection of adverse events and serious adverse events | 20th Day |
| Istanbul |
| Gaziosmanpaşa |
| 34255 |
| Turkey (Türkiye) |
| Kocaeli City Hospital | Kocaeli | İzmit | 41060 | Turkey (Türkiye) |
| Göztepe Süleyman Yalçın City Hospital | Istanbul | Kadıköy | 34722 | Turkey (Türkiye) |
| Kartal Dr. Lütfi Kırdar City Hospital | Istanbul | Kartal | 34865 | Turkey (Türkiye) |
| Akdeniz University | Antalya | Konyaaltı | 07070 | Turkey (Türkiye) |
| Süreyyapaşa Chest Disease and Thoracic Surgery Training and Research Hospital | Istanbul | Maltepe | 34844 | Turkey (Türkiye) |
| Umraniye Training and Research Hospital | Istanbul | Umraniye | 34764 | Turkey (Türkiye) |
| Antalya Atatürk Public Hospital | Antalya | 07040 | Turkey (Türkiye) |
| Cemil Taşcıoğlu City Hospital | Istanbul | Şişli | 34384 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided