Back to resultsOropharyngeal Immunoprophylaxis With High Polyphenolic Olive Oil as Clinical Spectrum Mitigating Factor in COVID-19. (COVID-19)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High polyphenolic olive oil. (Early harvest olive oil).
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19
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: Participation in other studies the 6 months before. Pregnant women. Inabilty to oral feeding. Diagnosis of any pathology able to increase risk.
Sites / Locations
- Hospital Nuestra Señora del Prado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
High polyphenolic olive oil
No intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incidence.
High polyphenolic olive oil immunoprophylaxis intervention and incidence of COVID-19.
Secondary Outcome Measures
Duration-
Time to resolution of symptoms of COVID-19 in participants versus normal population.
Severity.
Differences in severity of symptoms of COVID-19 between participants and control group.
Full Information
NCT ID
NCT05685901
First Posted
January 10, 2023
Last Updated
January 12, 2023
Sponsor
Hospital General Nuestra Señora del Prado
1. Study Identification
Unique Protocol Identification Number
NCT05685901
Brief Title
Oropharyngeal Immunoprophylaxis With High Polyphenolic Olive Oil as Clinical Spectrum Mitigating Factor in COVID-19.
Acronym
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Nuestra Señora del Prado
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High polyphenolic olive oil
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High polyphenolic olive oil. (Early harvest olive oil).
Intervention Description
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 Outcome Measure Information:
Title
Incidence.
Description
High polyphenolic olive oil immunoprophylaxis intervention and incidence of COVID-19.
Time Frame
3 months.
Secondary Outcome Measure Information:
Title
Duration-
Description
Time to resolution of symptoms of COVID-19 in participants versus normal population.
Time Frame
3 months
Title
Severity.
Description
Differences in severity of symptoms of COVID-19 between participants and control group.
Time Frame
3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
Participation in other studies the 6 months before.
Pregnant women.
Inabilty to oral feeding.
Diagnosis of any pathology able to increase risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Rodríguez
Organizational Affiliation
Head of Pediatric Department.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nuestra Señora del Prado
City
Talavera de la Reina.
State/Province
Toledo
ZIP/Postal Code
45600
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32892403
Citation
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Results Reference
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PubMed Identifier
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Citation
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Oropharyngeal Immunoprophylaxis With High Polyphenolic Olive Oil as Clinical Spectrum Mitigating Factor in COVID-19.
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