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

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.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Dietary supplement: High polyphenolic olive oil. (Early harvest olive oil).

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo
    • Talavera de la Reina., Toledo, Spain, 45600
      • Hospital Nuestra Señora del Prado

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High polyphenolic olive oil; Participants were required to take 2 mL of early harvest olive oil (normal early harvest olive oil) twice a day for three months and went through a clinical questionnaire at days 15, 30, 60 and 90. Participants were sent an envelope closed with instructions and informed consent. The primary outcome was to determine the effect of high polyphenolic olive oil on Coronavirus disease incidence, duration and severity. This study was approved by the independent ethic committee of the Hospital Nuestra Señora del Prado in Talavera de la Reina, belonging to the National Health System in Spain, and conducted in accordance with Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent was obtained from all patients. This questionnaire consisted in asking about having symptoms of SARS-CoV-2 infection, fever, low fever, malaise, headache, loss of smell, runny nose, sore throat.	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.
No Intervention: No intervention; Participants were required to complete a questionnaire at days 15, 30, 60 and 90 of the study. This questionnaire consisted in asking about having symptoms of SARS-CoV-2 infection, fever, low fever, malaise, headache, loss of smell, runny nose, sore throat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence.	High polyphenolic olive oil immunoprophylaxis intervention and incidence of COVID-19.	3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration-	Time to resolution of symptoms of COVID-19 in participants versus normal population.	3 months
Severity.	Differences in severity of symptoms of COVID-19 between participants and control group.	3 months.

Collaborators and Investigators

• Sponsor: Hospital General Nuestra Señora del Prado
• Investigators: Principal Investigator: Francisco Rodríguez, Head of Pediatric Department.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Estimate): January 16, 2023

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: OLEOCOVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No