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NCT05685901 | COMPLETED | COVID-19


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

Our Lady of Prado General Hospital

Information provided by (Responsible Party):

Francisco Rodríguez Argente

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.

Condition or disease

COVID-19

Intervention/treatment

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

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 88 participants
Masking : TRIPLE
Primary Purpose : PREVENTION
Official Title : Randomized and Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Oropharyngeal Immunoprophylaxis With Olive Oil Rich in Polyphenols as attenuation and prevention of the Infectious Disease Due to the SARS-CoV-2 Coronavirus.
Actual Study Start Date : 2021-07-01
Estimated Primary Completion Date : 2022-09-30
Estimated Study Completion Date : 2022-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.

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

Location Details

NCT05685901


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Locations


Not yet recruiting

Spain, Toledo

Our Lady of Prado Hospital

Talavera de la Reina., Toledo, Spain, 45600

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