Effects of Immulina TM Supplements with PASC Patients
Purpose
This is a multi-site study that will try to determine the effects of Immulina ™, a natural dietary supplement, on blood chemicals associated with inflammation that are often increased in patients with long COVID (also called PASC).
Condition
- Post Acute COVID-19 Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Males and females, 18 to 99 years old - If female of child bearing potential, using acceptable means of birth control or postmenopausal for at least two years - Body temperature between 36.1°C and 37.7°C. - Has completed the 4-week washout period (if applicable), i.e., has refrained from using internally-consumed dietary supplements prior to Study Day 1 and through the completion of the study - A minimum of 2 hours fasting (except water) prior to all of the blood draws - Willing and able (in the opinion of study staff) to comply with all study requirements, including swallowing size 4 capsules (approximately 0.5" long and 0.25" diameter) and having phlebotomy - Good written and verbal English skills; able to follow instructions (in the investigator's opinion) - Not participating in a clinical study, currently or within the last 30 days - Signed informed consent
Exclusion Criteria
- Pregnant or lactating - Digestive tract disorders or conditions, such as (but are not limited to): ulcers, ulcerative colitis, Crohn's disease, gastric bypass, colostomy, ischemic colitis, gastroesophageal reflux disease (GERD), irritable bowel disease (IBD), diverticulitis that would be expected to impact on the oral disposition of the Immulina dietary supplement - Existence of any surgical and/or medical condition, significant disease or disorder, or any finding that may, in the judgment of the investigator, put the volunteer at risk or compromise study participation. - Any blood-thinning or clotting concomitant medication (prescription anticoagulants) - Donation or loss of 400 mL or more of blood within 8 weeks of Study Day 1 or unwilling to abstain from donation of blood during the study - Known or suspected allergy or sensitivity to Immulina, cellulose - History of drug or alcohol abuse within the last 12 months
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Immulina TM 800 mg/day |
Immulina Dietary supplementation (200 mg per capsule) 2-200 mg capsules given by mouth in the morning and 2-200 mg capsules given by mouth in the evening for 8 weeks duration |
|
|
Placebo Comparator Placebo |
inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration |
|
Recruiting Locations
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
Louisiana State University
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
University of Oklahoma
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
West Virginia University
Morgantown, Virginia 26506
Morgantown, Virginia 26506
More Details
- NCT ID
- NCT05524532
- Status
- Recruiting
- Sponsor
- University of Mississippi Medical Center
Detailed Description
This is a randomized, double-blind placebo controlled pilot study designed to determine effect size on altering blood inflammatory biomarkers and anti SARS-CoV-2-specific adaptive response including memory T cell, memory B cells and antiviral antibody titers. The participants will have a variety of clinical manifestations that will include varying degrees of fatigue, cognitive dysfunction and other PASC-related symptoms. Individuals will be randomized by site to receive either Immulina or placebo given daily for 8 weeks followed by a 4 week observation off supplement.