COVID-19 Respiratory InfectionNCT06452069
Efficacy and Safety Study of Essential Oil-Based Preparation Administered to COVID-19 Patients
A study testing IMMUNO19 in people with COVID-19 Respiratory Infection and COVID-19, run by Biodex S.A at 10 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Respiratory Infection, COVID-19
- What is being tested?
- IMMUNO19
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 10 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 16Show fewer
- 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,
- Patients who did not give written informed consent.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Turkey (Türkiye)10 sites
Akdeniz University
Antalya, Konyaaltı, 07070
Antalya Atatürk Public Hospital
Antalya, 07040
Bağcılar Training and Research Hospital
Istanbul, Bagcılar, 34212
Gaziosmanpaşa Training and Research Hospital
Istanbul, Gaziosmanpaşa, 34255
Göztepe Süleyman Yalçın City Hospital
Istanbul, Kadıköy, 34722
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Kartal, 34865
Süreyyapaşa Chest Disease and Thoracic Surgery Training and Research Hospital
Istanbul, Maltepe, 34844
Umraniye Training and Research Hospital
Istanbul, Umraniye, 34764
Cemil Taşcıoğlu City Hospital
Istanbul, Şişli, 34384
Kocaeli City Hospital
Kocaeli, İzmit, 41060
About this study
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
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.
Read the detailed description
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:
- Either by neutralising the virus before it enters the cell,
- By changing the capsid or envelope of the virus,
- Either by binding to receptors used by viruses and preventing their access to cells.
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.
- Conditions
- COVID-19 Respiratory Infection, COVID-19
- Being tested
- IMMUNO19
- Keywords
- Essential Oil, antiviral, Main Protease, COVID 19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMMUNO19Other
Also called Essential Oils Combination
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1: (n=140) Investigational Product 10 ml, drinkable ampoule (1 ampoule) (1 time only) Receives: Other: IMMUNO19 |
| Group 2 | Placebo comparator | Group 2: (n=140) Placebo 10 ml (1 ampoule) (1 time only) Receives: Other: IMMUNO19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 20th Day
Virological evaluation
Qualitative PCR Test and Quantitative PCR Test
Measured: 0th Day
Virological evaluation
Qualitative PCR Test and Quantitative PCR Test
Measured: 6th Day
Virological evaluation
Qualitative PCR Test and Quantitative PCR Test
Measured: 10th Day
Virological evaluation
Qualitative PCR Test and Quantitative PCR Test
Measured: 20th Day
Secondary outcomes (9)
Evaluation of time from inclusion to recovery in days
Negative PCR and viral load
Measured: 0th Day
Evaluation of time from inclusion to recovery in days
Negative PCR and viral load
Measured: 6th Day
Evaluation of time from inclusion to recovery in days
Negative PCR and viral load
Measured: 10th Day
Evaluation of time from inclusion to recovery in days
Negative PCR and viral load
Measured: 20th Day
Incidence of adverse events and serious advers event
Collection of adverse events and serious adverse events
Measured: 0th Day
Incidence of adverse events and serious advers event
Collection of adverse events and serious adverse events
Measured: 2nd Day
Incidence of adverse events and serious advers event
Collection of adverse events and serious adverse events
Measured: 6th Day
Incidence of adverse events and serious advers event
Collection of adverse events and serious adverse events
Measured: 10th Day
Incidence of adverse events and serious advers event
Collection of adverse events and serious adverse events
Measured: 20th Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Prospective Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biodex S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gama CRO Tıbbi IIac Arastirma Org.Tic.Ltd.Sti
- Responsible party
- Sponsor
- Investigators
- Kanat Tayfun, MD, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452069
- Sponsor's protocol ID
- EC2021-ID19
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06452069
- Acronym / sponsor ID
- EC2021-ID19
- Conditions
- COVID-19 Respiratory Infection, COVID-19
- Keywords
- Essential Oil, antiviral, Main Protease, COVID 19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Biodex S.AIndustry (pharma, biotech, devices)
- Collaborators
- Gama CRO Tıbbi IIac Arastirma Org.Tic.Ltd.Sti
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Either by neutralising the virus before it enters the cell,
- By changing the capsid or envelope of the virus,
- Either by binding to receptors used by viruses and preventing their access to cells.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, Randomized, Prospective Study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: IMMUNO19Group 1: (n=140) Investigational Product 10 ml, drinkable ampoule (1 ampoule) (1 time only) |
| Group 2 | Placebo comparator | Other: IMMUNO19Group 2: (n=140) Placebo 10 ml (1 ampoule) (1 time only) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMMUNO19Also: Essential Oils Combination280 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. | Other | Group 1, Group 2 |
Primary outcome
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
Time frame: 0th Day
Day 0 Participant symptoms and quantitative PCR of viral load
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
Time frame: 2nd Day
Day 2 Participant symptoms
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
Time frame: 6th Day
Day 6 Participant symptoms and quantitative PCR of viral load
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
Time frame: 10th Day
Day 10 Participant symptoms and quantitative PCR of viral load
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.
Time frame: 20th Day
Day 20 Participant symptoms and quantitative PCR of viral load
Clinical recovery defined by the absence of clinical signs of infection
Time frame: 0th Day
Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms
Clinical recovery defined by the absence of clinical signs of infection
Time frame: 2nd Day
Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms
Clinical recovery defined by the absence of clinical signs of infection
Time frame: 6th Day
Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms
Clinical recovery defined by the absence of clinical signs of infection
Time frame: 10th Day
Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms
Clinical recovery defined by the absence of clinical signs of infection
Time frame: 20th Day
Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms
Aggravation of the clinical picture
Time frame: 0th Day
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
Aggravation of the clinical picture
Time frame: 2nd Day
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
Aggravation of the clinical picture
Time frame: 6th Day
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
Aggravation of the clinical picture
Time frame: 10th Day
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
Aggravation of the clinical picture
Time frame: 20th Day
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
Virological evaluation
Time frame: 0th Day
Qualitative PCR Test and Quantitative PCR Test
Virological evaluation
Time frame: 6th Day
Qualitative PCR Test and Quantitative PCR Test
Virological evaluation
Time frame: 10th Day
Qualitative PCR Test and Quantitative PCR Test
Virological evaluation
Time frame: 20th Day
Qualitative PCR Test and Quantitative PCR Test
9 secondary outcomes
Evaluation of time from inclusion to recovery in days
Time frame: 0th Day
Evaluation of time from inclusion to recovery in days
Time frame: 6th Day
Evaluation of time from inclusion to recovery in days
Time frame: 10th Day
Evaluation of time from inclusion to recovery in days
Time frame: 20th Day
Incidence of adverse events and serious advers event
Time frame: 0th Day
Incidence of adverse events and serious advers event
Time frame: 2nd Day
Incidence of adverse events and serious advers event
Time frame: 6th Day
Incidence of adverse events and serious advers event
Time frame: 10th Day
Incidence of adverse events and serious advers event
Time frame: 20th Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanat Tayfun, MD principal investigator
Bagcilar Training and Research Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMMUNO19 in people with COVID-19 Respiratory Infection and COVID-19, run by Biodex S.A at 10 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mounir Bezzarga (+216 98 362260, mounir.bezzarga@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 0th Day). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.