Effect of Immulina Supplements on Inflammatory Biomarkers Correlated With Clinical Symptoms in Patients With Long COVID (PASC)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 101
- Locations
- 9
- Primary Endpoint
- Plasma IL-6 (Interleukin 6, pg/mL)
Study Overview
Brief Summary
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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
Intervention: Immulina TM (Drug)
Placebo
inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Plasma IL-6 (Interleukin 6, pg/mL)
Time Frame: 12 weeks
Differences in Interleukin 6 from baseline to 12 weeks
Plasma D-Dimer, pg/mL
Time Frame: 12 weeks
Differences in D-Dimer from baseline to 12 weeks.
Plasma CRP (C-Reactive Protein, ng/mL)
Time Frame: 12 weeks
Differences in C-Reactive Protein from baseline to 12 weeks.
Secondary Outcomes
- Natural Killer (NK) cell count(12 weeks)
- serum Interferon alpha, pg/mL(12 weeks)
- PROMIS-29(12 weeks)
- SBQ-LC TM(12 weeks)
- FSS(12 weeks)
- SARS-CoV-2-specific antibody responses(12 weeks)
- SARS-CoV-2-specific immune responses on memory T cell levels(12 weeks)
- Cytolytic T lymphocyte (CTL) number(12 weeks)
- SARS-CoV-2-specific immune responses on memory B cell levels(12 weeks)
- Natural Killer cell (NK)-mediated cytotoxicity(12 weeks)
- serum Interferon gamma, pg/mL(12 weeks)