Immulina Supplement for Long COVID

No longer recruiting at 9 trial locations

Overseen By Sally Hodder

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Immulina™, a natural dietary supplement, can reduce inflammation in people with long COVID (also called PASC). Participants will take either Immulina™ or a placebo, a pill with no active ingredients, for eight weeks. The study seeks individuals experiencing long COVID symptoms, such as ongoing fatigue or brain fog, who are not currently taking dietary supplements. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Immulina, a natural dietary supplement, is generally safe for use. Although specific safety information about Immulina for long COVID is not available from other studies, its progression to phase 3 clinical trials indicates it has passed earlier safety tests. This suggests it is likely safe enough for larger groups. As a supplement, Immulina typically carries a lower risk of serious side effects compared to many prescription drugs. However, like any treatment, it might still cause mild side effects. Always consult a healthcare provider before starting any new treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for long COVID?

Unlike the standard treatments for Long COVID, which often focus on managing symptoms with medications like antihistamines or steroids, Immulina is a dietary supplement that aims to boost the immune system. Immulina is derived from spirulina, a blue-green algae known for its immune-modulating properties. Researchers are excited about Immulina because it targets the immune system in a natural way, potentially offering a more holistic approach to managing Long COVID symptoms. Additionally, the oral capsule form makes it easy to incorporate into daily routines, which could improve adherence and overall effectiveness.

What evidence suggests that Immulina TM might be an effective treatment for long COVID?

This trial will compare Immulina, a natural dietary supplement, with a placebo to assess its effects on long COVID. Research has shown that Immulina might help reduce inflammation in people with long COVID. Studies suggest that this supplement could lower certain blood chemicals linked to inflammation, which are often higher in those with long COVID. Long COVID, also known as post-acute sequelae of COVID-19 (PASC), can cause ongoing symptoms like tiredness and breathing problems. Immulina may help by calming the immune system and improving its function. While more research is needed, early findings are promising for those experiencing long COVID symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

Gailen D. Marshall, Jr., MD, PhD

Principal Investigator

University of Mississippi Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05524532?cond=COVID-19

Effects of Immulina TM Supplements With PASC Patients 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 ...

2. withpower.com withpower.com/trial/phase-covid-19-8-2022-5e14c

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11387218/

Post-Acute Sequelae of Covid-19: A System-wise Approach ... The mechanisms underlying these long-term complications are not fully understood, but they may be related to persistent inflammation, microvascular damage, and ...

4. nature.com nature.com/articles/s12276-025-01539-5

Prolonged immune activation in post-acute sequelae of ... Post-acute sequelae of SARS-CoV-2 (PASC) is characterized by persistent symptoms such as fatigue, respiratory complications and cognitive ...

5. mdpi.com mdpi.com/2218-273X/15/7/928

Immune Signatures in Post-Acute Sequelae of COVID-19 ... In this paper, we compare and contrast the ongoing clinical entity arising from acute COVID-19 infection variously known as Long COVID, long-haulers and such ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9305273/

Long COVID and its Management - PMC - PubMed Central The subacute and sequelae effects of SARS-CoV-2 infection are called various names, such as “long COVID”, “post-acute COVID syndrome”, “post ...