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 (COVID-19-IAMA)

January 11, 2021 updated by: Christor Lionis, University of Crete

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Crete
      • Heraklion, Crete, Greece
        • Cretan Medicare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cretan IAMA (CAPeo)
All patients are to receive Cretan IAMA (CAPeo) from Day 1.
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
Other Names:
  • CAPeo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with symptom resolution
Time Frame: 2 weeks (14 days)
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
Time Frame: 2 weeks (14 days) )
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
Time Frame: 2 weeks (14 days)
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
Time Frame: 2 weeks (14 days)
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
Time Frame: 2 weeks (14 days)
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)
Time Frame: 2 weeks (14 days)
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
Time Frame: 2 weeks (14 days)
EQ-5D-5L measurement of QoL
2 weeks (14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Crete

Collaborators

Galenica SA
Olvos Science SA

Investigators

  • Principal Investigator: Christos Lionis, University of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78/26.03.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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