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

Phase 2

Completed

• Conditions: Viral Infection; Covid19; Respiratory Viral Infection
• Interventions: Dietary Supplement: Cretan IAMA

• Registration Number: NCT04705753
• Lead Sponsor: University of Crete

Brief 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.

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 Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-01
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cretan IAMA (CAPeo)	Cretan IAMA	All patients are to receive Cretan IAMA (CAPeo) from Day 1.

Primary Outcome Measures

Name	Time	Method
Number of patients with symptom resolution	2 weeks (14 days)	Number of patients with symptoms recorded at baseline resolving at 2 weeks (14 days) or sooner
Number of people cohabiting with a patient not developing VRI symptoms	2 weeks (14 days) )	Number of people cohabiting with a patient who did not develop VRI symptoms (per patient) at 2 weeks (14 days)

Secondary Outcome Measures

Name	Time	Method
Intensity of symptoms	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).
Median time to full symptom resolution	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)
Duration of symptoms	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)
Number of patients whose symptoms never exceeded a score of 3-4 (mild)	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
Quality of life (QoL) of patients	2 weeks (14 days)	EQ-5D-5L measurement of QoL

Trial Locations

Locations (1)

Cretan Medicare; 🇬🇷 Heraklion, Crete, Greece