Effects of Immulina supplements on long COVID symptoms
Effect of Immulina Supplements on Inflammatory Biomarkers Correlated with Clinical Symptoms in Patients with Long COVID (PASC)
PHASE3 · University of Mississippi Medical Center · NCT05524532
This study is testing if taking Immulina, a natural supplement, can help people with long COVID symptoms like fatigue and brain fog feel better by looking at changes in their inflammation levels.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Mississippi Medical Center (other) |
| Locations | 9 sites (Honolulu, Hawaii and 8 other locations) |
| Trial ID | NCT05524532 on ClinicalTrials.gov |
What this trial studies
This multi-site, randomized, double-blind, placebo-controlled pilot study aims to evaluate the effects of Immulina™, a natural dietary supplement, on inflammatory biomarkers in patients suffering from Post Acute COVID-19 Syndrome (PASC). Participants will be randomly assigned to receive either Immulina or a placebo daily for 8 weeks, followed by a 4-week observation period without the supplement. The study will assess changes in blood chemicals associated with inflammation and the adaptive immune response, including memory T cells and antiviral antibodies. Participants will include individuals with various PASC-related symptoms such as fatigue and cognitive dysfunction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 who have experienced symptoms of long COVID and meet the study's eligibility criteria.
Not a fit: Patients who are pregnant, lactating, or have digestive tract disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary supplement option to alleviate symptoms associated with long COVID.
How similar studies have performed: While there is ongoing research into dietary supplements for long COVID, this specific approach using Immulina is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Honolulu, Hawaii and 8 other locations
- University of Hawaii — Honolulu, Hawaii, United States (RECRUITING)
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (RECRUITING)
- Louisiana State University — New Orleans, Louisiana, United States (RECRUITING)
- MaineHealth — Portland, Maine, United States (RECRUITING)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (RECRUITING)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (RECRUITING)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (RECRUITING)
- West Virginia University — Morgantown, Virginia, United States (RECRUITING)
- University of Puerto Rico — San Juan, Puerto Rico (RECRUITING)
Study contacts
- Principal investigator: Gailen D Marshall, Jr., MD, PhD — University of Mississippi Medical Center
- Study coordinator: Amy Wigglesworth, RN
- Email: awigglesworth@umc.edu
- Phone: 6018153464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Acute COVID-19 Syndrome, Immulina, Post Acute Covid-19 Syndrome, Inflammation, Natural Dietary Supplement