Effects of Immulina TM Supplements With PASC Patients

NCT05524532 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: 2022-272U54GM115428
• Study Type: interventional
• Target: 101
• Locations: 2 countries
• Sites: 9

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).

Conditions

Post Acute COVID-19 Syndrome

Keywords

Immulina; Post Acute Covid-19 Syndrome; Inflammation; Natural Dietary Supplement

Outcome Measures

Primary Outcomes (3)

• Plasma IL-6 (Interleukin 6, pg/mL)

  Differences in Interleukin 6 from baseline to 12 weeks

  12 weeks

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

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

  12 weeks

• Plasma D-Dimer, pg/mL

  Differences in D-Dimer from baseline to 12 weeks.

  12 weeks

Secondary Outcomes (11)

• PROMIS-29

  12 weeks

• FSS

  12 weeks

• SBQ-LC TM

  12 weeks

• SARS-CoV-2-specific antibody responses

  12 weeks

• SARS-CoV-2-specific immune responses on memory T cell levels

  12 weeks

Study Arms (2)

Immulina TM 800 mg/day

EXPERIMENTAL

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

Drug: Immulina TM

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Immulina TM 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.

Also known as: Spirulina

Immulina TM 800 mg/day

Placebo DIETARY_SUPPLEMENT

Placebo is an inert form of cellulose acetate.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (9)

University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

MaineHealth

Portland, Maine, 04101, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

West Virginia University

Morgantown, Virginia, 26506, United States

Location

University of Puerto Rico

San Juan, Puerto Rico, 00935, Puerto Rico

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Inflammation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gailen D Marshall, Jr., MD, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: September 1, 2022
• Study Start: July 20, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); PR (1)