Prevention of flu and flu like symptoms Infections and Infestations
Conditions
Interventions
This study will enroll 75 healthy participants. One gender will not exceed 65% and that one age category will not exceed 40%. Each participant must fulfill the inclusion criteria and not meet any of t
Sponsors
Unigen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females between 40 and 80 years of age, inclusive 2. Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening, or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) • Double-barrier method • Intrauterine devices • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) • Vasectomy of partner at least 6 months prior to screening 3. Participants who have not yet but willing to receive the influenza vaccine 4. Agrees to provide a verbal history of flu vaccination 5. Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements 6. Healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI) 7. Willingness to complete questionnaires and diaries associated with the study and to complete all clinic visits 8. Provided voluntary, written, informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, breast feeding, or planning to become pregnant during the study 2. Participant has a known allergy to the active or inactive ingredients in UP360, UP446, placebo, or QIV 3. Self-reported diagnosis of COVID-19 prior to baseline 4. Unvaccinated participants with self-reported flu prior to baseline 5. Current use of prescribed immunomodulators (including corticosteroids) such as immunosuppressants or immunostimulants within 4 weeks of baseline 6. Current use of dietary supplement or herbal medicines associated with boosting or modulating the immune system. 7. Current use of specific prescribed cardiac medication or over-the-counter medication or supplements that may aggravate electrolyte imbalance as assessed by QI 8. Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI 9. Individuals who are unable to give informed consent 10. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the increase in immune parameters as assessed by lymphocyte populations (CD3+, CD4+, CD8+,CD25+) and immunoglobulins (IgG, IgM, and IgA) in blood between UP360, UP446 and placebo at Day 28 and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference between UP360, UP446 and placebo at Day 28 and 56 in: 1.1. Number of confirmed COVID-19 infections 1.2. Impact of COVID-19 on quality of life assessed by the COVID-19 Impact on QoL Questionnaire 2. The difference between UP360, UP446 and placebo at Day 56 in: 2.1. Number of hospitalizations due to COVID-19 3. The difference in change between UP360, UP446 and placebo at Day 28 and 56 in: 3.1. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) 3.2. Hematology parameters: white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), reticulocyte count, red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and red cell distribution width (RDW) 3.3. Complement C3 and C4 proteins 3.4. Mean global severity index, as measured by area under the curve (AUC) for the Modified Wisconsin Upper Respiratory Symptom Survey (WURSS)-24 daily symptom scores 3.5. Mean symptom severity scores, as measured by AUC for the WURSS-24 daily severity symptom scores 3.6. Number of well days (defined as days scored as 0 (not sick) for the question, “How sick do you feel today?”) as assessed by the Modified WURSS-24 Questionnaire 3.7. Number of sick days (defined as days scored as any number from 1 through 7 (sick) for the question, “How sick do you feel today?”) as assessed by the Modified WURSS-24 Questionnaire 3.8. Frequency of common upper respiratory tract infection (UTRI) symptoms as assessed by the Modified WURSS-24 Questionnaire 3.9. Duration of common UTRI symptoms as assessed by the Modified WURSS-24 Questionnaire 3.10. Severity of common UTRI symptoms as assessed by the Modified WURSS-24 Questionnaire 3.11. Vitality and quality of life as assessed by the Vitality and Quality of Life (QoL) Questionnaire | — |
Countries
Canada
Outcome results
None listed