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

Covid19 Clinical Trial

— COVID-19-IAMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04705753
• Other study ID #: 78/26.03.2020
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 1, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2021
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single-arm, open-label small interventional proof-of-concept (POC) study study aims:

1. 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,

2. 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

3. to investigate its prophylactic effect in terms of transmission prevention for people cohabiting with the patients exhibiting VRI symptoms.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Covid19
• Infection
• Respiratory Tract Infections
• Respiratory Viral Infection
• Viral Infection
• Virus Diseases

Intervention

Dietary Supplement:
• Cretan IAMA
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

Locations

Country	Name	City	State
Greece	Cretan Medicare	Heraklion	Crete

Sponsors (3)

Lead Sponsor	Collaborator
University of Crete	Galenica SA, Olvos Science SA

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Anastasaki M, Bertsias A, Pirintsos SA, Castanas E, Lionis C. Post-market outcome of an extract of traditional Cretan herbs on upper respiratory tract infections: a pragmatic, prospective observational study. BMC Complement Altern Med. 2017 Sep 21;17(1):4 — View Citation

Duijker G, Bertsias A, Symvoulakis EK, Moschandreas J, Malliaraki N, Derdas SP, Tsikalas GK, Katerinopoulos HE, Pirintsos SA, Sourvinos G, Castanas E, Lionis C. Reporting effectiveness of an extract of three traditional Cretan herbs on upper respiratory t — View Citation

Lionis C, Faresjö A, Skoula M, Kapsokefalou M, Faresjö T. Antioxidant effects of herbs in Crete. Lancet. 1998 Dec 19-26;352(9145):1987-8. — View Citation

Pirintsos SA, Bariotakis M, Kampa M, Sourvinos G, Lionis C, Castanas E. The Therapeutic Potential of the Essential Oil of Thymbra capitata (L.) Cav., Origanum dictamnus L. and Salvia fruticosa Mill. And a Case of Plant-Based Pharmaceutical Development. Fr — View Citation

Tseliou, M., Pirintsos, S. A., Lionis, C., Castanas, E., and Sourvinos, G. (2019). Antiviral effect of an essential oil combination derived from three aromatic plants (Coridothymus capitatus (L.) Rchb. f., Origanum dictamnus L. and Salvia fruticosa Mill.)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Quality of life (QoL) of patients	EQ-5D-5L measurement of QoL	2 weeks (14 days)