Effects of Immulina TM Supplements with PASC Patients

University of Mississippi

Status and phase: Enrolling; Phase 3

Conditions: Post Acute COVID-19 Syndrome

Treatments: Drug: Immulina TM; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05524532

2022-272

U54GM115428 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Immulina TM 800 mg/day

Experimental group

Description:

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

Treatment:

Drug: Immulina TM

Placebo

Placebo Comparator group

Description:

inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration

Treatment:

Dietary Supplement: Placebo