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Effects of Immulina TM Supplements With PASC Patients

Primary Purpose

Post Acute COVID-19 Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Immulina TM
Placebo
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Acute COVID-19 Syndrome focused on measuring Immulina, Post Acute Covid-19 Syndrome, Inflammation, Natural Dietary Supplement

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Hawaii
  • Pennington Biomedical Research Center
  • Louisiana State University
  • Tulane University
  • MaineHealth
  • University of Mississippi Medical CenterRecruiting
  • University of Nebraska Medical Center
  • University of Oklahoma
  • West Virginia University
  • University of Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Immulina TM 800 mg/day

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plasma IL-6 (Interleukin 6, pg/mL)
Differences in Interleukin 6 from baseline to 12 weeks
Plasma CRP (C-Reactive Protein, ng/mL)
Differences in C-Reactive Protein from baseline to 12 weeks.
Plasma D-Dimer, pg/mL
Differences in D-Dimer from baseline to 12 weeks.

Secondary Outcome Measures

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).
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.
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.
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
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
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
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.
Natural Killer (NK) cell count
Difference in NK cell counts from baseline to 20 weeks.
Cytolytic T lymphocyte (CTL) number
Difference in CTL cell number from baseline to 20 weeks.
serum Interferon alpha, pg/mL
Difference in Interferon alpha from baseline to 20 weeks.
serum Interferon gamma, pg/mL
Difference in Interferon gamma from baseline to 20 weeks.

Full Information

First Posted
July 18, 2022
Last Updated
August 29, 2023
Sponsor
University of Mississippi Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05524532
Brief Title
Effects of Immulina TM Supplements With PASC Patients
Official Title
Effect of Immulina Supplements on Inflammatory Biomarkers Correlated With Clinical Symptoms in Patients With Long COVID (PASC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Acute COVID-19 Syndrome
Keywords
Immulina, Post Acute Covid-19 Syndrome, Inflammation, Natural Dietary Supplement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immulina TM 800 mg/day
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
inert capsules; 2 capsules given by mouth in the morning and 2 capsules given by mouth in the evening for 8 weeks duration
Intervention Type
Dietary Supplement
Intervention Name(s)
Immulina TM
Other Intervention Name(s)
Spirulina
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo is inert powder in cellulose capsule that appears identical to Immulina TM capsules
Primary Outcome Measure Information:
Title
Plasma IL-6 (Interleukin 6, pg/mL)
Description
Differences in Interleukin 6 from baseline to 12 weeks
Time Frame
12 weeks
Title
Plasma CRP (C-Reactive Protein, ng/mL)
Description
Differences in C-Reactive Protein from baseline to 12 weeks.
Time Frame
12 weeks
Title
Plasma D-Dimer, pg/mL
Description
Differences in D-Dimer from baseline to 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PROMIS-29
Description
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).
Time Frame
12 weeks
Title
FSS
Description
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.
Time Frame
12 weeks
Title
SBQ-LC TM
Description
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.
Time Frame
12 weeks
Title
SARS-CoV-2-specific antibody responses
Description
Differences in SARS-CoV-2-specific antibody immune responses: Receptor Binding domain (RBD) and Nucleocapsid (NP) antibody responses between baseline and 12 weeks
Time Frame
12 weeks
Title
SARS-CoV-2-specific immune responses on memory T cell levels
Description
Differences in SARS-CoV-2-specific immune responses on memory T cell levels between baseline and 12 weeks
Time Frame
12 weeks
Title
SARS-CoV-2-specific immune responses on memory B cell levels
Description
Differences in SARS-CoV-2-specific immune responses on memory B cell levels between baseline and 12 weeks
Time Frame
12 weeks
Title
Natural Killer cell (NK)-mediated cytotoxicity
Description
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.
Time Frame
12 weeks
Title
Natural Killer (NK) cell count
Description
Difference in NK cell counts from baseline to 20 weeks.
Time Frame
12 weeks
Title
Cytolytic T lymphocyte (CTL) number
Description
Difference in CTL cell number from baseline to 20 weeks.
Time Frame
12 weeks
Title
serum Interferon alpha, pg/mL
Description
Difference in Interferon alpha from baseline to 20 weeks.
Time Frame
12 weeks
Title
serum Interferon gamma, pg/mL
Description
Difference in Interferon gamma from baseline to 20 weeks.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donielle N Drakes, MBA
Phone
6014967821
Email
ddrakes@umc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Montgomery, MT(ASCP)
Phone
6018155374
Email
dmontgomery@umc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gailen D Mashall, Jr., MD, PhD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Vares-Lum
Email
dianavl@hawaii.edu
First Name & Middle Initial & Last Name & Degree
Debra Ogata-Arakaki
Email
ogataara@hawaii.edu
First Name & Middle Initial & Last Name & Degree
Cecilia Shikuma
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Leonhard
Email
robert.leonhard@pbrc.edu
First Name & Middle Initial & Last Name & Degree
Frank Greenway
Facility Name
Louisiana State University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Garrison
Email
vgarri@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Mary Meyaski
Email
mmeyas@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Judd Shellito
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Logarbo
Email
blogarbo@tulane.edu
First Name & Middle Initial & Last Name & Degree
Michele Longo
Facility Name
MaineHealth
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivette Emery, PhD
Email
ivette.emery@mainehealth.org
First Name & Middle Initial & Last Name & Degree
Cole Ferm
Email
nicole.ferm@mainehealth.org
First Name & Middle Initial & Last Name & Degree
Katherine Sharp
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donielle D Drakes, MBA
Phone
601-496-7821
Email
ddrakes@umc.edu
First Name & Middle Initial & Last Name & Degree
Denise Montgomery, MT(ASCP)
Phone
6018155374
Email
dmontgomery@umc.edu
First Name & Middle Initial & Last Name & Degree
Gailen D Marshall Jr., MD, PhD
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Mathisen, MA
Email
tracy.mathisen@unmc.edu
First Name & Middle Initial & Last Name & Degree
Karen Blessing
Email
kablessing@unmc.edu
First Name & Middle Initial & Last Name & Degree
Andy Vasey
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Carmichael, BA
Email
cathy-carmichael@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Sukrutha Thotala
Email
sukrutha-thotala@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Timothy VanWagoner
Facility Name
West Virginia University
City
Morgantown
State/Province
Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Childers
Email
margaret.childers@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Michelle Chidester
Email
michelle.chidester@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Sally Hodder
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Davila
Email
sylvia.davila1@upr.edu
First Name & Middle Initial & Last Name & Degree
Litza Pabon
Email
litza.pabon@upr.edu
First Name & Middle Initial & Last Name & Degree
Jorge L Santana Bagur

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Immulina TM Supplements With PASC Patients

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