COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05435144

not reported

not reported

2022-06-28

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: provision of signed and dated informed consent form stated willingness and demonstrated ability to comply with all study procedures and availability for the duration of the study aged 20-65 lives in the united states within driving distance of the research center in good general health as evidenced by medical history bmi <31 ability to take oral supplements and willing to commit to taking 2 capsules a day for 3 months for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the intervention period employed full time in an occupation with direct and prolonged exposure to the public (i.e. teacher, healthcare provider, etc) or regularly engaged in high exposure activities. agreement to adhere to lifestyle considerations throughout study duration

current use of the following pharmaceuticals: immunosuppressants pregnancy, trying to conceive or breastfeeding organ transplant recipient known allergic reactions to elderberries positive covid-19 test within 180 days of the study period covid vaccine of any type scheduled during the intervention period or the week prior to the start of the study receipt of 4+ covid-19 vaccines current diagnosis or lifetime history of an autoimmune condition (including but not limited to lupus, addisons, graves, hypothyroidism, multiple sclerosis, or type 1 diabetes) or cancer or chronic kidney disease or chronic liver disease or chronic lung disease (i.e. copd, pulmonary embolism) or cystic fibrosis or severe heart disease (i.e. heart failure, coronary artery disease, cardiomyopathy) or hiv infection or immunocompromised status or sickle cell disease or tuberculosis recent dramatic weight changes (10% change in body weight in the last 6 months) existing usage of a polyphenol-based supplement, including but not limited to elderberry, cranberry, bilberry, quercetin, or resveratrol. existing usage of an immune supporting supplement such as echinacea, probiotics, elderberry, or any other dietary supplements marketed as immune support. routine dietary consumption of high levels of polyphenols or anthocyanins as determined by dietary intake questionnaire.

2

Franklin Health Research

20

65

United States

Healthy volunteers

N/A

420

Duration of Upper Respiratory Events;Incidence of Upper Respiratory Events;Incidence of Upper Respiratory Symptomatic Days;Symptom Severity

None

Not reported

[{"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "nan", "treatment_id": 2549, "treatment_name": "Elderberry extract eldercraft", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]