Status:
COMPLETED
Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19
Lead Sponsor:
Arizona State University
Conditions:
Inflammation
COVID19
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who ar...
Detailed Description
Inflammation is at the core of many chronic conditions and exacerbates infectious conditions, and inflammatory responses appear to be key determinants of the severity of COVID-19 infection. Hence, con...
Eligibility Criteria
Inclusion
- Male and females 18-65 years old
- Generally healthy
- Able to provide informed consent
- Recent positive COVID-19 test (per RT-PCR Test)\*
Exclusion
- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, HIV, lung conditions or chronic asthma)
- Serious mood disorders, neurological disorders such as MS, or cognitive damage
- Active smokers and/or nicotine or drug abuse
- Active, regular marijuana or other cannabinoid use, other street/recreational drug use
- Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula including peanuts, eggs or turmeric
- Pregnant or lactating woman
- People medically prescribed to take drugs that would affect the immune and/or the inflammatory response
- People who have had treatment (last 5 years) for cancer, or chronic use of steroids
- BMI \>40
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04912921
Start Date
October 20 2020
End Date
May 15 2022
Last Update
March 8 2023
Active Locations (1)
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1
Arizona Biomedical Collaborative
Phoenix, Arizona, United States, 85004