Effects of Immulina TM Supplements With PASC Patients

University of Mississippi Medical Center101 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

101

Conditions

Post Acute COVID-19 Syndrome

Interventions

Immulina TMDRUG

Immulina TM is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiiating properties.

PlaceboDIETARY_SUPPLEMENT

Placebo is an inert form of cellulose acetate.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

University of Hawaii

Honolulu, Hawaii, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Louisiana State University

New Orleans, Louisiana, United States

MaineHealth

Outcomes

Primary Outcomes

Plasma IL-6 (Interleukin 6, pg/mL)

Differences in Interleukin 6 from baseline to 12 weeks

Time frame: 12 weeks

Plasma CRP (C-Reactive Protein, ng/mL)

Differences in C-Reactive Protein from baseline to 12 weeks.

Time frame: 12 weeks

Plasma D-Dimer, pg/mL

Differences in D-Dimer from baseline to 12 weeks.

Time frame: 12 weeks

Secondary Outcomes

PROMIS-29

Differences in questionnaire PROMIS-29, Domain T-scores PROMIS-29 is a collection of short forms containing a fixed number of items from the same 7 PROMIS domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) plus a single item on pain intensity. They assess all domains over the past seven days except the Physical Function, which has no timeframe specified. Four questions asked for each of 7 domains, plus the single pain intensity item and scored separately, yielding a total of 7 domain scores. The final score is represented by the T-Score, a standardized score with a mean of 50 and a standard deviation \[SD\] of 10. High scores mean more of the concept being measured (e.g., more fatigue, more Physical Function).

Time frame: 12 weeks

FSS

Differences in Fatigue Severity Scale (FSS) questionnaire between baseline to 12 weeks Changes in questionnaire FSS, units on a scale, results that reflect PASC-associated symptoms of fatigue, neurocognitive dysfunction, dyspnea and/or other symptoms. The questionnaire FSS contains nine statements that rate the severity of fatigue symptoms. Respondents rate their fatigue severity during the past seven days using a 7 point rating scale. A low value (e.g.1) indicates strong disagreement with the statement, whereas a high value (e.g.7) indicates strong agreement. A total score of less than 36 suggests that the respondent may not be suffering from fatigue. A total score of 36 or more suggests that the respondent may need further evaluation by a physician.

Data from ClinicalTrials.gov

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