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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM115428 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immulina TM | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma IL-6 (Interleukin 6, pg/mL) | Differences in Interleukin 6 from baseline to 12 weeks | 12 weeks |
| Plasma CRP (C-Reactive Protein, ng/mL) | Differences in C-Reactive Protein from baseline to 12 weeks. | 12 weeks |
| Plasma D-Dimer, pg/mL | Differences in D-Dimer from baseline to 12 weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gailen D Marshall, Jr., MD, PhD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii | Honolulu | Hawaii | 96813 | United States | ||
| Pennington Biomedical Research Center |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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|
| Placebo | Dietary Supplement | Placebo is an inert form of cellulose acetate. |
|
| 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. | 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. | 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 | 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 | 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 | 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. | 12 weeks |
| Natural Killer (NK) cell count | Difference in NK cell counts from baseline to 20 weeks. | 12 weeks |
| Cytolytic T lymphocyte (CTL) number | Difference in CTL cell number from baseline to 20 weeks. | 12 weeks |
| serum Interferon alpha, pg/mL | Difference in Interferon alpha from baseline to 20 weeks. | 12 weeks |
| serum Interferon gamma, pg/mL | Difference in Interferon gamma from baseline to 20 weeks. | 12 weeks |
| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| Louisiana State University | New Orleans | Louisiana | 70112 | United States |
| MaineHealth | Portland | Maine | 04101 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| West Virginia University | Morgantown | Virginia | 26506 | United States |
| University of Puerto Rico | San Juan | Puerto Rico | 00935 | Puerto Rico |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |