Assessment of the Clinical Effectiveness of a Herbal Extract (Cretan IAMA) in Patients With Viral Respiratory Infections, Including COVID-19, in Primary Healthcare Settings, and Co-assessment of Its Prophylactic Effect in People Cohabiting With These Patients

Study Overview
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Brief Summary
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This single-arm, open-label small interventional proof-of-concept (POC) study study aims: to assess the clinical outcomes of patients exhibiting viral respiratory infection (VRI) symptoms and seeking primary healthcare (PHC) services at the time of the COVID-19 pandemic, to assess the clinical effectiveness of the Cretan IAMA (CAPeo), a herbal extract combination, for these patients, including in terms of symptom resolution (symptom frequency, duration) and intensity), and to investigate its prophylactic effect in terms of transmission prevention for people cohabiting with the patients exhibiting VRI symptoms.

Detailed Description
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Cretan IAMA (CAPeo) is an essential oil mixture of three native herbs of Crete (Thymbra capitata (L.) Cav., Salvia fruticosa Mill. and Origanum dictamnus L.), which exhibits remarkable in vitro antiviral activity against Influenza A & B and the Human Rhinovirus HRV-14 strains, decreasing the symptoms of upper respiratory tract viral infections. It has also been proven safe in experimental animals and humans. There is currently a strong unmet medical need for safe and effective therapeutic regimens for patients in ambulatory settings. Given its properties, it was, therefore, deemed both appropriate and urgent to explore its potential in the context of COVID-19 for patients in primary care settings. It was also deemed important to investigate the Cretan IAMA (CAPeo) regarding prophylactic treatment for people coming in close contact with these ambulatory patients. Single-arm, open label (proof-of-concept) study to assess the potential of Cretan IAMA (CAPeo) benefit of COVID-19 as a therapeutic and prophylactic agent VRI/COVID-19 patients seeking primary health care services at home SARS-CoV-2 infection testing by real-time RT-PCR, performed in the regional COVID-19 reference centre (Laboratory of Clinical Virology, University of Crete, School of Medicine) Cretan IAMA (CAPeo) to be administered in the form of two 0.5 ml soft capsules, in a concentration of 15 ml/L, daily for two weeks (14 days), per os Data collection on Day 1 (baseline), Day 4, Day 7 and Day 14

Official Title
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Evaluation of the Clinical Outcomes and the Quality of Life of Patients Exhibiting Symptoms Characteristic of Viral Respiratory Infection (VRI), Including Infection by SARS-CoV-2 (COVID-19), and Assessment of the Clinical Effectiveness of a Herbal Extract (Cretan IAMA) in These Patients and the People Cohabiting With Them Via an Open-label, Single-arm Trial

Conditions
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Covid19, Viral Infection, Respiratory Viral Infection

Intervention / Treatment
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* Dietary Supplement: Cretan IAMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the patients: Any woman or man requesting a home visit and having symptoms characteristic of viral infection, with initial manifestation within the previous 48-72 hrs. Such symptoms may include sudden fever onset, accompanied by one or more of the following symptoms: dry cough, sore throat, nasal congestion, headache, musculoskeletal pain, perspiration, fatigue, malaise, blurry vision, loss of the sense of smell. For the people cohabiting with patients: Any woman or man cohabiting with study patients. Exclusion Criteria: Children and adolescents under the age of 18 years; Pregnant women; Persons suffering from a pre-existing condition preventing them from autonomously providing informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cretan IAMA (CAPeo)<br>All patients are to receive Cretan IAMA (CAPeo) from Day 1. | Dietary Supplement: Cretan IAMA<br>* Cretan IAMA (CAPeo) soft gels, 1 ml/day of a 1.5% essential oil combination from three aromatic plants (Thymbra 59 capitata (L.) Cav., Origanum dictamnus L., Salvia fruticosa Mill.) in extra virgin olive oil<br>* Other names: CAPeo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with symptom resolution | Number of patients with symptoms recorded at baseline resolving at 2 weeks (14 days) or sooner | 2 weeks (14 days) | 
| Number of people cohabiting with a patient not developing VRI symptoms | Number of people cohabiting with a patient who did not develop VRI symptoms (per patient) at 2 weeks (14 days) | 2 weeks (14 days) ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to full symptom resolution | Median time to full symptom resolution, including those emerging after Day 1 adjusted for symptoms emerging after Day 1 (Baseline symptoms) | 2 weeks (14 days) | 
| Intensity of symptoms | Intensity of symptoms, incl. of those emerging after Day 1 (Baseline symptoms), and adjusted for symptoms emerging after Day 1 (Baseline symptoms), scoring on the seven-point Likert scale based on a questionnaire adapted from the Wisconsin Upper Respiratory System Survey - A seven-point Likert scale allowed recording 131 of reported symptoms starting from 1 (minor) to 2 (very mild) and 3 (mild), 4 (somewhat moderate) and 132 5 (moderate) and culminating to 6 (severe) and 7 (very severe). | 2 weeks (14 days) | 
| Duration of symptoms | Duration of symptoms, incl. of those emerging after Day 1 (Baseline symptoms) and adjusted for symptoms emerging after Day 1 (Baseline symptoms) | 2 weeks (14 days) | 
| Number of patients whose symptoms never exceeded a score of 3-4 (mild) | Number of patients whose symptoms never exceeded a score of 3-4 (mild) on the seven-point Likert scale based on a questionnaire adapted from the Wisconsin Upper Respiratory System Survey | 2 weeks (14 days) | 
| Quality of life (QoL) of patients | EQ-5D-5L measurement of QoL | 2 weeks (14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infectious disease, Herbal Medicine, Botanical Medicine