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OpenTrials
Completed

NCT Number: NCT05685901

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence.

    Time frame: 3 months.

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

Secondary outcomes

  1. Duration-

    Time frame: 3 months

    Time to resolution of symptoms of COVID-19 in participants versus normal population.

  2. Severity.

    Time frame: 3 months.

    Differences in severity of symptoms of COVID-19 between participants and control group.

Sponsors and collaborators

Lead sponsor

Hospital General Nuestra Señora del Prado

Other

Registry information

Official study 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.

Acronym: COVID-19

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 17, 2023
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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