Effects of Immulina TM Supplements With PASC Patients

NCT ID: NCT05524532

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2025-07-29

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.

Conditions

Post Acute COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Immulina TM

Intervention Type: DRUG

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo is an inert form of cellulose acetate.

Interventions

Immulina TM

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.

Intervention Type: DRUG

Placebo

Placebo is an inert form of cellulose acetate.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Spirulina

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gailen D Marshall, Jr., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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

Portland, Maine, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

West Virginia University

Morgantown, Virginia, United States

University of Puerto Rico

San Juan, Puerto Rico, Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

U54GM115428

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-272

Identifier Type: -

Identifier Source: org_study_id