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  

Covid19 Clinical Trial

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

Status Completed

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT04705753
• Study type: Interventional
• Source: University of Crete
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 1, 2020
• Completion date: October 15, 2020