Clinical trial NCT05524532: Effects of Immulina TM Supplements with PASC Patients
Official title: Effect of Immulina Supplements on Inflammatory Biomarkers Correlated with Clinical Symptoms in Patients with Long COVID (PASC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Post Acute COVID-19 Syndrome
Keywords: Immulina
Post Acute Covid-19 Syndrome
Inflammation
Natural Dietary Supplement
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2022-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma IL-6 (Interleukin 6, pg/mL)
timeFrame: 12 weeks
measure: Plasma CRP (C-Reactive Protein, ng/mL)
timeFrame: 12 weeks
measure: Plasma D-Dimer, pg/mL
timeFrame: 12 weeks
Secondary outcomes:
measure: PROMIS-29
timeFrame: 12 weeks
measure: FSS
timeFrame: 12 weeks
measure: SBQ-LC TM
timeFrame: 12 weeks
measure: SARS-CoV-2-specific antibody responses
timeFrame: 12 weeks
measure: SARS-CoV-2-specific immune responses on memory T cell levels
timeFrame: 12 weeks
measure: SARS-CoV-2-specific immune responses on memory B cell levels
timeFrame: 12 weeks
measure: Natural Killer cell (NK)-mediated cytotoxicity
timeFrame: 12 weeks
measure: Natural Killer (NK) cell count
timeFrame: 12 weeks
measure: Cytolytic T lymphocyte (CTL) number
timeFrame: 12 weeks
measure: serum Interferon alpha, pg/mL
timeFrame: 12 weeks
measure: serum Interferon gamma, pg/mL
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Portland
country: United States
facility: MaineHealth
state: Maine
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Morgantown
country: United States
facility: West Virginia University
state: Virginia
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D Marshall, Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: