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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Dietary Supplement: High polyphenolic olive oil. (Early harvest olive oil).

• Registration Number: NCT05685901
• Lead Sponsor: Hospital General Nuestra Señora del Prado

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-12
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High polyphenolic olive oil	High polyphenolic olive oil. (Early harvest 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.

Primary Outcome Measures

Name	Time	Method
Incidence.	3 months.	High polyphenolic olive oil immunoprophylaxis intervention and incidence of COVID-19.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Nuestra Señora del Prado; 🇪🇸 Talavera de la Reina., Toledo, Spain