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

NCT05685901 | Completed DMC

• 1 other identifier: OLEOCOVID
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence.

  High polyphenolic olive oil immunoprophylaxis intervention and incidence of COVID-19.

  3 months.

Secondary Outcomes (2)

• Duration-

  3 months

• Severity.

  3 months.

Study Arms (2)

High polyphenolic olive oil

EXPERIMENTAL

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).

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.

Interventions

High polyphenolic olive oil. (Early harvest olive oil). DIETARY_SUPPLEMENT

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.

High polyphenolic olive oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participation in other studies the 6 months before.
• Pregnant women.
• Inabilty to oral feeding.
• Diagnosis of any pathology able to increase risk.

Sponsors & Collaborators

• Hospital General Nuestra Señora del Prado: lead

Study Sites (1)

Hospital Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

Related Publications (9)

• 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.

  PMID: 32892403 BACKGROUND

• 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.

  PMID: 21858748 BACKGROUND

• 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.

  PMID: 27344959 BACKGROUND

• 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.

  PMID: 31978945 BACKGROUND

• 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.

  PMID: 2170159 BACKGROUND

• 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.

  PMID: 32205856 BACKGROUND

• 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.

  PMID: 30744092 BACKGROUND

• 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.

  PMID: 23487566 BACKGROUND

• 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.

  PMID: 27713254 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Francisco Rodríguez

  Head of Pediatric Department.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Department

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 17, 2023
• Study Start: July 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)