Effects of Immulina TM Supplements With PASC Patients
Completed · Phase 3 · Has a placebo group
Conditions studied: Post Acute COVID-19 Syndrome
In brief
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).
Key facts
- Study ID
- NCT05524532
- Run by
- University of Mississippi Medical Center
- People needed
- 101
- Starts
- 2023-07-20
- Expected to finish
- 2025-07-29
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.