Post Acute COVID-19 SyndromePhase 3NCT05524532
Effects of Immulina TM Supplements With PASC Patients
A Phase 3 study testing Immulina TM in people with Post Acute COVID-19 Syndrome, run by University of Mississippi Medical Center at 9 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Acute COVID-19 Syndrome
- What is being tested?
- Immulina TM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 20 Jul 2023to 29 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
University of Hawaii
Honolulu, Hawaii, 96813
University of Mississippi Medical Center
Jackson, Mississippi, 39216
West Virginia University
Morgantown, Virginia, 26506
Louisiana State University
New Orleans, Louisiana, 70112
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
MaineHealth
Portland, Maine, 04101
About this study
Official title: Effect of Immulina Supplements on Inflammatory Biomarkers Correlated With Clinical Symptoms in Patients With Long COVID (PASC)
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).
Read the detailed description
This is a randomized, double-blind placebo controlled pilot study designed to determine effect size on altering blood inflammatory biomarkers and anti SARS-CoV-2-specific adaptive response including memory T cell, memory B cells and antiviral antibody titers. The participants will have a variety of clinical manifestations that will include varying degrees of fatigue, cognitive dysfunction and other PASC-related symptoms. Individuals will be randomized by site to receive either Immulina or placebo given daily for 8 weeks followed by a 4 week observation off supplement.
- Conditions
- Post Acute COVID-19 Syndrome
- Being tested
- Immulina TM, Placebo
- Keywords
- Immulina, Post Acute Covid-19 Syndrome, Inflammation, Natural Dietary Supplement
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immulina TMDrug
Also called Spirulina
Immulina TM is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiiating properties.
PlaceboDietary supplement
Placebo is an inert form of cellulose acetate.
| Study group | Role | What they receive |
|---|---|---|
| Immulina TM 800 mg/day | Experimental | 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 Receives: Drug: Immulina TM |
| Placebo | Placebo comparator | inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma IL-6 (Interleukin 6, pg/mL)
Differences in Interleukin 6 from baseline to 12 weeks
Measured: 12 weeks
Plasma CRP (C-Reactive Protein, ng/mL)
Differences in C-Reactive Protein from baseline to 12 weeks.
Measured: 12 weeks
Plasma D-Dimer, pg/mL
Differences in D-Dimer from baseline to 12 weeks.
Measured: 12 weeks
Secondary outcomes (11)
PROMIS-29
Differences in questionnaire PROMIS-29, Domain T-scores PROMIS-29 is a collection of short forms containing a fixed number of items from the same 7 PROMIS domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) plus a single item on pain intensity. They assess all domains over the past seven days except the Physical Function, which has no timeframe specified. Four questions asked for each of 7 domains, plus the single pain intensity item and scored separately, yielding a total of 7 domain scores. The final score is represented by the T-Score, a standardized score with a mean of 50 and a standard deviation [SD] of 10. High scores mean more of the concept being measured (e.g., more fatigue, more Physical Function).
Measured: 12 weeks
FSS
Differences in Fatigue Severity Scale (FSS) questionnaire between baseline to 12 weeks
Changes in questionnaire FSS, units on a scale, results that reflect PASC-associated symptoms of fatigue, neurocognitive dysfunction, dyspnea and/or other symptoms.
The questionnaire FSS contains nine statements that rate the severity of fatigue symptoms. Respondents rate their fatigue severity during the past seven days using a 7 point rating scale. A low value (e.g.1) indicates strong disagreement with the statement, whereas a high value (e.g.7) indicates strong agreement. A total score of less than 36 suggests that the respondent may not be suffering from fatigue. A total score of 36 or more suggests that the respondent may need further evaluation by a physician.
Measured: 12 weeks
SBQ-LC TM
Differences in The Symptom Burden Questionnaire for Long COVID (SBQ-LC TM) questionnaire between baseline to 12 weeks
Changes in questionnaire SBQ-LC TM (units on a scale) results that reflect PASC-associated symptoms of fatigue, neurocognitive dysfunction, dyspnea and/or other symptoms .
SBQ-LC TM (version 1.0) is a modular instrument measuring patient reported outcomes and is composed of 17 independent scales with promising psychometric properties. Respondents rate their symptom burden during the past seven days using a dichotomous response or 4 point rating scale. Each scale provides coverage of a different symptom domain and returns a summed raw score that can be transformed to a linear (0-100) score. Higher scores represent higher symptom burden.
Measured: 12 weeks
SARS-CoV-2-specific antibody responses
Differences in SARS-CoV-2-specific antibody immune responses: Receptor Binding domain (RBD) and Nucleocapsid (NP) antibody responses between baseline and 12 weeks
Measured: 12 weeks
SARS-CoV-2-specific immune responses on memory T cell levels
Differences in SARS-CoV-2-specific immune responses on memory T cell levels between baseline and 12 weeks
Measured: 12 weeks
SARS-CoV-2-specific immune responses on memory B cell levels
Differences in SARS-CoV-2-specific immune responses on memory B cell levels between baseline and 12 weeks
Measured: 12 weeks
Natural Killer cell (NK)-mediated cytotoxicity
NK cell-mediated cytotoxicity is characterized by cytolysis of a CSFE-labeled (K562) by effector cells (NK cells). Labeled K562 are cultured with NK cells for a period of time, then all cells labeled with a live-dead stain, 7-AAD. The cytolytic actively is expressed as the percent dead K562.
Difference in cytolytic activity (%dead K562) from baseline to 20 weeks.
Measured: 12 weeks
Natural Killer (NK) cell count
Difference in NK cell counts from baseline to 20 weeks.
Measured: 12 weeks
Cytolytic T lymphocyte (CTL) number
Difference in CTL cell number from baseline to 20 weeks.
Measured: 12 weeks
serum Interferon alpha, pg/mL
Difference in Interferon alpha from baseline to 20 weeks.
Measured: 12 weeks
serum Interferon gamma, pg/mL
Difference in Interferon gamma from baseline to 20 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start20 Jul 2023
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Gailen D Marshall, Jr., MD, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524532
- Sponsor's protocol ID
- 2022-272
- Other IDs
- U54GM115428
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immulina Supplements on Inflammatory Biomarkers Correlated With Clinical Symptoms in Patients With Long COVID (PASC)
- ClinicalTrials.gov ID
- NCT05524532
- Acronym / sponsor ID
- 2022-272
- Conditions
- Post Acute COVID-19 Syndrome
- Keywords
- Immulina, Post Acute Covid-19 Syndrome, Inflammation, Natural Dietary Supplement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a randomized, double-blind placebo controlled pilot study designed to determine effect size on altering blood inflammatory biomarkers and anti SARS-CoV-2-specific adaptive response including memory T cell, memory B cells and antiviral antibody titers. The participants will have a variety of clinical manifestations that will include varying degrees of fatigue, cognitive dysfunction and other PASC-related symptoms. Individuals will be randomized by site to receive either Immulina or placebo given daily for 8 weeks followed by a 4 week observation off supplement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immulina TM 800 mg/day | Experimental | Drug: Immulina TMImmulina 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 |
| Placebo | Placebo comparator | Dietary Supplement: Placeboinert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immulina TMAlso: SpirulinaImmulina TM is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiiating properties. | Drug | Immulina TM 800 mg/day |
| PlaceboPlacebo is an inert form of cellulose acetate. | Dietary supplement | Placebo |
Primary outcome
Plasma IL-6 (Interleukin 6, pg/mL)
Time frame: 12 weeks
Differences in Interleukin 6 from baseline to 12 weeks
Plasma CRP (C-Reactive Protein, ng/mL)
Time frame: 12 weeks
Differences in C-Reactive Protein from baseline to 12 weeks.
Plasma D-Dimer, pg/mL
Time frame: 12 weeks
Differences in D-Dimer from baseline to 12 weeks.
11 secondary outcomes
PROMIS-29
Time frame: 12 weeks
FSS
Time frame: 12 weeks
SBQ-LC TM
Time frame: 12 weeks
SARS-CoV-2-specific antibody responses
Time frame: 12 weeks
SARS-CoV-2-specific immune responses on memory T cell levels
Time frame: 12 weeks
SARS-CoV-2-specific immune responses on memory B cell levels
Time frame: 12 weeks
Natural Killer cell (NK)-mediated cytotoxicity
Time frame: 12 weeks
Natural Killer (NK) cell count
Time frame: 12 weeks
Cytolytic T lymphocyte (CTL) number
Time frame: 12 weeks
serum Interferon alpha, pg/mL
Time frame: 12 weeks
serum Interferon gamma, pg/mL
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gailen D Marshall, Jr., MD, PhD principal investigator
University of Mississippi Medical Center
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immulina TM in people with Post Acute COVID-19 Syndrome, run by University of Mississippi Medical Center at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma IL-6 (Interleukin 6, pg/mL) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.