Oropharyngeal Immunoprophylaxis With High Polyphenolic Olive Oil as Clinical Spectrum Mitigating Factor in COVID-19.

COVID-19 Clinical Trial

— COVID-19  

Official title:

Ensayo clínico Aleatorizado y Controlado Para la evaluación de la Eficacia y Seguridad de la Inmunoprofilaxis orofaríngea Con Aceite de Oliva Rico en Polifenoles Como atenuación y prevención de la Enfermedad Infecciosa Por el Coronavirus SARS-CoV-2.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05685901
• Other study ID #: OLEOCOVID
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: Hospital General Nuestra Señora del Prado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Immunomodulation of local immune response at the oropharyngeal mucosa can hypothetically activate mucosal immunity, which can difficult SARS-CoV-2 main immune evasion mechanisms in early stages of the disease and send an effective warning to the adaptive immune system. There are previous studies on immunotherapeutic management of upper respiratory tract infections with olive polyphenols. The investigators would like to study if participants following oromucosal immunomodulation with tiny quantities of high polyphenolic olive oil (early harvest olive oil) could have more possibilities to have less severe symptoms and a better outcome after SARS-CoV-2 infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult men and non-pregnant women were eligible if they had been in contact of recent COVID-19 diagnosed people and radomly allocated to olive oil group or not treatment at all group.

Exclusion Criteria:

1. Participation in other studies the 6 months before.

2. Pregnant women.

3. Inabilty to oral feeding.

4. Diagnosis of any pathology able to increase risk.

Related Conditions & MeSH terms

• COVID-19

Intervention

Dietary Supplement:
• High polyphenolic olive oil. (Early harvest olive oil).
High polyphenolic olive oil is normal olive oil obtained from early harvest olives, this early harvest olive oil has been widely used for culinary purposes for centuries. The investigators wanted to study if oromucosal immunoprophylaxis with small quantities of high polyphenolic olive oil (2 mL of olive oil equivalent to 5 mg of polyphenols) adiministered twice a day could have clinical mitigating effects on the disease caused by SARS-CoV-2 infection.The primary outcome was to determine the effect of high polyphenolic olive oil on Coronavirus disease incidence, duration and severity.

Locations

Country	Name	City	State
Spain	Hospital Nuestra Señora del Prado	Talavera de la Reina.	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Nuestra Señora del Prado

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Beilharz MW, Cummins MJ, Bennett AL, Cummins JM. Oromucosal Administration of Interferon to Humans. Pharmaceuticals (Basel). 2010 Jan 28;3(2):323-344. doi: 10.3390/ph3020323. — View Citation

Brandtzaeg P. Secretory immunity with special reference to the oral cavity. J Oral Microbiol. 2013;5. doi: 10.3402/jom.v5i0.20401. Epub 2013 Mar 11. — View Citation

Callow KA, Parry HF, Sergeant M, Tyrrell DA. The time course of the immune response to experimental coronavirus infection of man. Epidemiol Infect. 1990 Oct;105(2):435-46. doi: 10.1017/s0950268800048019. — View Citation

de Wit E, van Doremalen N, Falzarano D, Munster VJ. SARS and MERS: recent insights into emerging coronaviruses. Nat Rev Microbiol. 2016 Aug;14(8):523-34. doi: 10.1038/nrmicro.2016.81. Epub 2016 Jun 27. — View Citation

Greenberg SB. Update on rhinovirus and coronavirus infections. Semin Respir Crit Care Med. 2011 Aug;32(4):433-46. doi: 10.1055/s-0031-1283283. Epub 2011 Aug 19. — View Citation

Rodriguez-Argente F, Alba-Dominguez M, Ortiz-Munoz E, Ortega-Gonzalez A. Oromucosal immunomodulation as clinical spectrum mitigating factor in SARS-CoV-2 infection. Scand J Immunol. 2021 Jan;93(1):e12972. doi: 10.1111/sji.12972. Epub 2020 Sep 18. — View Citation

Shi Y, Wang Y, Shao C, Huang J, Gan J, Huang X, Bucci E, Piacentini M, Ippolito G, Melino G. COVID-19 infection: the perspectives on immune responses. Cell Death Differ. 2020 May;27(5):1451-1454. doi: 10.1038/s41418-020-0530-3. Epub 2020 Mar 23. No abstract available. — View Citation

Somerville V, Moore R, Braakhuis A. The Effect of Olive Leaf Extract on Upper Respiratory Illness in High School Athletes: A Randomised Control Trial. Nutrients. 2019 Feb 9;11(2):358. doi: 10.3390/nu11020358. — View Citation

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence.	High polyphenolic olive oil immunoprophylaxis intervention and incidence of COVID-19.	3 months.
Secondary	Duration-	Time to resolution of symptoms of COVID-19 in participants versus normal population.	3 months
Secondary	Severity.	Differences in severity of symptoms of COVID-19 between participants and control group.	3 months.