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

Launched by BIODEX S.A · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of an essential oil-based product on patients with mild to moderate COVID-19 symptoms. Researchers want to see if this product can safely help in treating the virus by targeting specific proteins that the virus needs to grow and spread. The trial is not yet recruiting participants, but when it begins, it will focus on adults aged 18 to 65 who have tested positive for COVID-19 and are experiencing mild to moderate symptoms. Participants will need to agree not to receive any COVID-19 vaccines during the trial.

To be eligible for the trial, participants must be in good enough health to take part and not have severe COVID-19 symptoms or other serious health issues that could complicate their participation. Those who join the trial will be asked to provide informed consent, meaning they will agree to participate after being fully informed about the study. If you or someone you know fits the eligibility criteria and is interested, it’s important to understand that this trial seeks to explore a new way to potentially improve the treatment of COVID-19 symptoms using essential oils.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.