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Clinical Trial NCT06452069 for COVID-19 Respiratory Infection, COVID-19 is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Efficacy and Safety Study of Essential Oil-Based Preparation Administered to COVID-19 Patients 280
Clinical Trial NCT06452069 is an interventional study for COVID-19 Respiratory Infection, COVID-19 and is currently not yet recruiting. Enrollment is planned to begin on 15 September 2024 and continue until the study accrues 280 participants. Led by Biodex S.A, this study is expected to complete by 15 September 2025. The latest data from ClinicalTrials.gov was last updated on 13 June 2024.
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 adopt...Show More
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. Therefo...
Show MoreOfficial 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
Conditions
COVID-19 Respiratory InfectionCOVID-19Other Study IDs
- EC2021-ID19
NCT ID Number
Start Date (Actual)
2024-09-15
Last Update Posted
2024-06-13
Completion Date (Estimated)
2025-09-15
Enrollment (Estimated)
280
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Essential Oil, antiviral, Main Protease, COVID 19
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGroup 1 Group 1: (n=140) Investigational Product 10 ml, drinkable ampoule (1 ampoule) (1 time only) | 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. |
Placebo ComparatorGroup 2 Group 2: (n=140) Placebo 10 ml (1 ampoule) (1 time only) | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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 | 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 |
| Outcome Measure | 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 | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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,
- Patients who did not give written informed consent.
Biodex S.AGama CRO Tıbbi IIac Arastirma Org.Tic.Ltd.StiStudy Central Contact
Contact: Mounir Bezzarga, +216 98 362260, [email protected]
Contact: İklim Turkoz, +90 543 259 59 40, [email protected]
10 Study Locations in 1 Countries
Bagcılar
Bağcılar Training and Research Hospital, Istanbul, Bagcılar, 34212, Turkey (Türkiye)
Gaziosmanpaşa
Gaziosmanpaşa Training and Research Hospital, Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)
İzmit
Kocaeli City Hospital, Kocaeli, İzmit, 41060, Turkey (Türkiye)
Kadıköy
Göztepe Süleyman Yalçın City Hospital, Istanbul, Kadıköy, 34722, Turkey (Türkiye)
Kartal
Kartal Dr. Lütfi Kırdar City Hospital, Istanbul, Kartal, 34865, Turkey (Türkiye)
Konyaaltı
Akdeniz University, Antalya, Konyaaltı, 07070, Turkey (Türkiye)
Maltepe
Süreyyapaşa Chest Disease and Thoracic Surgery Training and Research Hospital, Istanbul, Maltepe, 34844, Turkey (Türkiye)
Umraniye
Umraniye Training and Research Hospital, Istanbul, Umraniye, 34764, Turkey (Türkiye)
Antalya Atatürk Public Hospital, Antalya, 07040, Turkey (Türkiye)
Şişli
Cemil Taşcıoğlu City Hospital, Istanbul, Şişli, 34384, Turkey (Türkiye)