NCT05524532

Effects of Immulina TM Supplements With PASC Patients

Effect of Immulina Supplements on Inflammatory Biomarkers Correlated With Clinical Symptoms in Patients With Long COVID (PASC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.
DIETARY_SUPPLEMENT	Placebo	Placebo is an inert form of cellulose acetate.

Timeline

• Start date: 2023-07-20
• Primary completion: 2025-07-29
• Completion: 2025-07-29
• First posted: 2022-09-01
• Last updated: 2025-08-14

Locations

9 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study