What side effects are associated with this type of intervention?

Common treatments for Long COVID Syndrome that have anti-inflammatory effects, similar to Immulina™, include corticosteroids and immune modulators. Known side effects of corticosteroids can include increased risk of infections, hypertension, hyperglycemia, and psychiatric effects such as mood swings and insomnia. Immune modulators, like tocilizumab, may cause gastrointestinal issues, increased risk of infections, and potential liver enzyme abnormalities. It is important to consult with a healthcare provider to weigh the benefits and risks of these treatments.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Long COVID Syndrome. However, various anti-inflammatory treatments are being studied, including natural dietary supplements like Immulina™. These treatments aim to reduce inflammation, which is a common issue in Long COVID patients. Other treatments under investigation include corticosteroids and biologics, which have shown some promise in managing symptoms related to inflammation in COVID-19 patients.

What other types of research exist?

Promising novel alternatives to Immulina™ for Long COVID Syndrome patients include intravenous immunoglobulin (IVIg) and its mimetics, which have shown effectiveness in autoimmune and inflammatory conditions. Additionally, imiquimod, which boosts interferon response and decreases pro-inflammatory responses, may also be considered.

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Dietary Supplement

Immulina Supplement for Long COVID

Phase 3

Recruiting

Led By Gailen D Marshall, 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

Awards & highlights

Pivotal Trial

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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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

0 / 2Eligibility criteria met

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.