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Dietary Supplement
Immulina Supplement for Long COVID
N/A
Recruiting
Led By Gailen D Mashall, Jr., MD, PhD
Research Sponsored by University of Mississippi Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial tests if Immulina, a natural supplement, can help patients with long COVID by reducing inflammation and boosting their immune system.
Who is the study for?
Adults aged 18-99 with normal body temperature and not pregnant or breastfeeding can join this trial. They must be willing to avoid other dietary supplements for 4 weeks before the study, swallow size 4 capsules, and have blood drawn. People with digestive disorders, recent drug/alcohol abuse, or on blood thinners cannot participate.
What is being tested?
The study is testing Immulina TM, a natural supplement thought to reduce inflammation in long COVID patients. Participants will either receive Immulina TM or a placebo without knowing which one they're taking to compare effects on blood chemicals linked to inflammation.
What are the potential side effects?
Potential side effects are not specified but may include reactions related to allergies or sensitivities to Immulina's ingredients like cellulose. Since it's a dietary supplement being tested against a placebo, side effects might be minimal.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking blood-thinning medication.
Select...
I haven't lost or donated 400 mL of blood in the last 8 weeks and won't donate during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma CRP (C-Reactive Protein, ng/mL)
Plasma D-Dimer, pg/mL
Plasma IL-6 (Interleukin 6, pg/mL)
Secondary study objectives
Cytolytic T lymphocyte (CTL) number
FSS
Natural Killer (NK) cell count
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Immulina TM 800 mg/dayExperimental Treatment1 Intervention
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 II: PlaceboPlacebo Group1 Intervention
inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Long COVID Syndrome, particularly those with anti-inflammatory effects like Immulina™, work by modulating the immune response and reducing inflammatory markers in the blood. These treatments are crucial because persistent inflammation is a key feature of Long COVID, contributing to symptoms such as fatigue, muscle pain, and cognitive issues.
By targeting and reducing inflammation, these treatments can help alleviate these symptoms and improve the overall quality of life for patients suffering from Long COVID Syndrome.
TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.
TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.
Find a Location
Who is running the clinical trial?
University of NebraskaOTHER
554 Previous Clinical Trials
1,145,232 Total Patients Enrolled
Pennington Biomedical Research CenterOTHER
308 Previous Clinical Trials
179,112 Total Patients Enrolled
West Virginia UniversityOTHER
183 Previous Clinical Trials
63,745 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a digestive condition that could affect how my body absorbs supplements.You should not eat anything for at least 2 hours before getting your blood drawn, but you can still drink water.I am taking blood-thinning medication.I am using birth control or have been postmenopausal for at least two years.I haven't lost or donated 400 mL of blood in the last 8 weeks and won't donate during the study.Your body temperature is between 97°F and 99.9°F.I am between 18 and 99 years old.You have had problems with drugs or alcohol in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Immulina TM 800 mg/day
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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