Clinical trial NCT05685901: Oropharyngeal Immunoprophylaxis With High Polyphenolic Olive Oil as Clinical Spectrum Mitigating Factor in 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: Hospital General Nuestra Señora del Prado
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence.
timeFrame: 3 months.
Secondary outcomes:
measure: Duration-
timeFrame: 3 months
measure: Severity.
timeFrame: 3 months.
Other outcomes:
Locations:
city: Talavera de la Reina.
country: Spain
facility: Hospital Nuestra Señora del Prado
state: Toledo
Study officials:
affiliation: Head of Pediatric Department.
name: Francisco Rodríguez
role: PRINCIPAL_INVESTIGATOR
References:
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