COVID-19
Conditions
Keywords
COVID-19
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.
Interventions
DIETARY_SUPPLEMENTHigh polyphenolic olive oil. (Early harvest olive oil).
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.
Sponsors
Hospital General Nuestra Señora del Prado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence. | 3 months. | High polyphenolic olive oil immunoprophylaxis intervention and incidence of COVID-19. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed