Clinical trial NCT04705753: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Covid19
Viral Infection
Respiratory Viral Infection
Keywords: Infectious disease
Herbal Medicine
Botanical Medicine
Lead sponsor: University of Crete
Sponsor class: OTHER
Collaborators: name: Galenica SA
name: Olvos Science SA
First posted: 2021-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with symptom resolution
timeFrame: 2 weeks (14 days)
measure: Number of people cohabiting with a patient not developing VRI symptoms
timeFrame: 2 weeks (14 days) )
Secondary outcomes:
measure: Median time to full symptom resolution
timeFrame: 2 weeks (14 days)
measure: Intensity of symptoms
timeFrame: 2 weeks (14 days)
measure: Duration of symptoms
timeFrame: 2 weeks (14 days)
measure: Number of patients whose symptoms never exceeded a score of 3-4 (mild)
timeFrame: 2 weeks (14 days)
measure: Quality of life (QoL) of patients
timeFrame: 2 weeks (14 days)
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Cretan Medicare
state: Crete
Study officials:
affiliation: University of Crete
name: Christos Lionis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lionis C, Faresjo A, Skoula M, Kapsokefalou M, Faresjo T. Antioxidant effects of herbs in Crete. Lancet. 1998 Dec 19-26;352(9145):1987-8. doi: 10.1016/S0140-6736(05)61333-5. No abstract available.
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 tract infection: results from a double-blind randomized controlled trial. J Ethnopharmacol. 2015 Apr 2;163:157-66. doi: 10.1016/j.jep.2015.01.030. Epub 2015 Jan 30.
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.) against viruses causing infections of the upper respiratory tract. J. Herb. Med. 17-18, 100288. doi:10.1016/j.hermed.2019.100288.
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. Front Pharmacol. 2020 Nov 24;11:522213. doi: 10.3389/fphar.2020.522213. eCollection 2020.
citation: 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):466. doi: 10.1186/s12906-017-1978-7.