Immulina Supplement for Long COVID

Recruiting at 9 trial locations

Overseen By Gailen D Marshall Jr., MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Mississippi Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Digestive disorders, Blood donation, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if Immulina, a natural supplement, can help patients with long COVID by reducing inflammation and boosting their immune system.

Do I have to stop taking my current medications for the trial?

The trial requires a 4-week period without taking any dietary supplements before starting. If you are on blood-thinning medications, you cannot participate. Other medications are not specifically mentioned, so it's best to discuss with the study staff.

How does the Immulina treatment for Long COVID differ from other treatments?

Immulina is unique because it is a nutritional supplement that acts as an immunostimulant, potentially enhancing the body's immune response, unlike standard pharmaceutical drugs. It includes components like pidotimod, which has been shown to reduce the frequency and severity of infections in other conditions, making it a novel approach for managing Long COVID symptoms. ^{1 2 3 4 5}

Research Team

Gailen D. Marshall, Jr., MD, PhD

Principal Investigator

University of Mississippi Medical Center

Eligibility Criteria

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.

Inclusion Criteria

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

You should not eat anything for at least 2 hours before getting your blood drawn, but you can still drink water.

I am using birth control or have been postmenopausal for at least two years.

Exclusion Criteria

I have a digestive condition that could affect how my body absorbs supplements.

I am taking blood-thinning medication.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Immulina or placebo daily for 8 weeks

8 weeks

Weekly visits (in-person or virtual)

Observation

Participants are observed off supplement to assess changes in inflammatory biomarkers and immune responses

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Immulina TM
• Placebo

Trial Overview 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.

Participant Groups

Group I: Immulina TM 800 mg/day Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration

Immulina TM is already approved in India for the following indications:

Approved in India as Pidotimod for:

• Recurrent upper and lower respiratory tract infections
• Acute respiratory tract infections
• Asthma
• Chronic obstructive pulmonary disorders
• Chronic bronchitis
• Immunological disorders
• Urinary tract infections

Who Is Running the Clinical Trial?

University of Mississippi Medical Center

Lead Sponsor

Trials

185

Recruited

200,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

MaineHealth

Collaborator

Trials

76

Recruited

43,800+

University of Hawaii

Collaborator

Trials

122

Recruited

55,200+

University of Puerto Rico

Collaborator

Trials

69

Recruited

22,300+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Tulane University

Collaborator

Trials

129

Recruited

259,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Findings from Research

A 70-year-old patient undergoing chemotherapy showed minimal antibody response after the first two COVID-19 vaccinations, but a significant immune response was achieved after the third vaccination, indicating that booster shots can be effective even in patients with chronic immunosuppressive treatment.

The patient developed a strong antibody response and cellular immunity after the third vaccination, demonstrating that effective immune responses can occur despite ongoing chemotherapy, without any adverse reactions noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Covid-19 vaccines elicit effective IgG responses in an elderly thymus cancer patient with chemotherapy. Koller, A., Szebeni, J.[2023]

In a randomized, double-blind, placebo-controlled study of 100 COVID-19 patients, the herbal and mineral formulation ImmuActive significantly improved disease severity, with patients showing a mean change of 0.57 on the ordinal scale compared to 1.0 in the placebo group (p = 0.0043).

Patients receiving ImmuActive experienced a faster recovery, taking an average of 2.35 days to improve by one unit on the severity scale, compared to 3.36 days for those on placebo, with no adverse events reported, indicating its safety as an adjunct therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional Supplement (ImmuActiveTM) for COVID-19 Patients. Majeed, M., Nagabhushanam, K., Shah, K., et al.[2022]

In a study of 86 patients with immunomediated diseases (IMIDs) treated with immunosuppressants, 86% showed a humoral response to the SARS-CoV-2 vaccine, but antibody levels were significantly lower compared to healthy controls, particularly in those treated with rituximab.

Despite lower antibody levels, a cellular immune response was still detected in some patients, indicating that even with impaired humoral immunity, some level of protection may be present; severe infections post-vaccination were rare, primarily occurring in rituximab-treated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune response after SARS-CoV-2 vaccination in patients with inflammatory immune-mediated diseases receiving immunosuppressive treatment. Plasencia-Rodríguez, C., Martínez-Feito, A., Hernández, M., et al.[2023]

In a study of 88 multiple sclerosis patients, 72 showed some immune response to SARS-CoV-2 vaccination, indicating that vaccination can still be effective in this population.

While certain disease-modifying treatments (DMTs) like fingolimod and anti-CD20+ therapies reduced the strength of the antibody response, most patients were able to generate a cellular immune response, suggesting the need for booster doses to enhance overall immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of humoral and cellular immunity after SARS-CoV-2 vaccination in patients with multiple sclerosis treated with immunomodulatory drugs. Meca-Lallana, V., Esparcia-Pinedo, L., Aguirre, C., et al.[2023]

In a double-blind randomized trial involving 416 children with recurrent respiratory infections, pidotimod significantly reduced the duration and frequency of infections compared to placebo over a 60-day treatment period.

The treatment with pidotimod also led to fewer days of fever, less severe symptoms, reduced use of antibiotics and antipyretics, and decreased school absences, all while demonstrating excellent safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pidotimod in the management of recurrent pharyngotonsillar infections in childhood. Passali, D., Calearo, C., Conticello, S.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Covid-19 vaccines elicit effective IgG responses in an elderly thymus cancer patient with chemotherapy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional Supplement (ImmuActiveTM) for COVID-19 Patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Immune response after SARS-CoV-2 vaccination in patients with inflammatory immune-mediated diseases receiving immunosuppressive treatment. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Analysis of humoral and cellular immunity after SARS-CoV-2 vaccination in patients with multiple sclerosis treated with immunomodulatory drugs. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Pidotimod in the management of recurrent pharyngotonsillar infections in childhood. [2013]