Post-Acute Sequelae of SARS-CoV-2 InfectionIVIG-LCNCT06992401
Observational Study of Intranasal IVIG in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients Undergoing Medical Tourism
An observational study of Post-Acute Sequelae of SARS-CoV-2 Infection and Long COVID, run by Tamara C Tamas.
Trial summary
This observational study is being conducted by Healing Hope International to collect real-world data on an emerging treatment approach for Long COVID in patients with immunodeficiency. The study investigates the effects of intranasal immunoglobulin (IVIG) therapy in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Acute Sequelae of SARS-CoV-2 Infection, Long COVID, Long COVID Fatigue
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 15 Jul 2029
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolls adults aged 18 to 65 with persistent Long COVID symptoms and confirmed immunodeficiency, including low IgG/IgA or poor vaccine response. Participants must have elevated inflammatory markers and be free of active infections or neurological conditions. The population is observed while undergoing intranasal IVIG therapy internationally, with a focus on immunological, genetic, and quality of life outcomes.
Who may be able to join
- Age 18 to 65 years
- Clinical diagnosis of Long COVID (symptoms persisting ≥12 weeks after SARS-CoV-2 infection)
- Laboratory-confirmed immunodeficiency, including one or more of the following:
- Low serum IgG and/or IgA
- Specific antibody deficiency
- Low pneumonia titers
Show all 10Show fewer
- Elevated inflammatory markers (e.g., CRP, cytokines)
- No active infections at the time of enrollment (bacterial, viral, or fungal)
- Negative for Lyme disease and NMDAR antibodies
- Willingness to provide informed consent for data collection and use
Who cannot join
- Current or recent active infection (e.g., viral, bacterial, or fungal)
- Use of immunosuppressive therapy within the last 3 months
- Active infections: Participants with active infections, including viral, bacterial, or fungal infections, will be excluded
- Neurological disorders: Participants with diagnosed neurological disorders (e.g., multiple sclerosis, Parkinson's disease, Alzheimer's disease) will be excluded
- Immunosuppressive therapy: Participants receiving immunosuppressive therapy will be excluded
- Inability to comply with study assessments or procedures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Observational Study Collecting Real-World Data on Intranasal IVIG Treatment in Long COVID-19 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients With Immunodeficiency Engaged in International Medical Tourism
This observational study is being conducted by Healing Hope International to collect real-world data on an emerging treatment approach for Long COVID in patients with immunodeficiency. The study investigates the effects of intranasal immunoglobulin (IVIG) therapy in a real-world setting.
Participants will be individuals diagnosed with Long COVID who have confirmed immunodeficiency, such as low IgG or IgA levels or specific antibody deficiency. These individuals are receiving care through international clinical programs and will not receive any treatment as part of this study. Instead, Healing Hope will collect health information, clinical outcomes, and laboratory results from participating sites to better understand how intranasal IVIG might help reduce symptoms such as fatigue, brain fog, inflammation, and immune dysregulation.
The goal of this study is to contribute new insights into potential treatment options for Long COVID and to support responsible, science-backed care models for patients participating in medical tourism. No experimental drugs are being administered as part of this protocol. All treatment decisions are made independently by each clinical site. Data will be anonymized and used to advance knowledge in the field of immunological recovery and neuroinflammation.
Read the detailed description
This observational study, initiated by Healing Hope International, is designed to collect real-world data (RWD) from individuals diagnosed with Long COVID who are undergoing clinical care involving intranasal immunoglobulin (IVIG) therapy at international medical tourism sites.
Eligible participants are adults (ages 18-65) with:
Persistent Long COVID symptoms for ≥12 weeks following SARS-CoV-2 infection,
Laboratory-confirmed immunodeficiency (e.g., low IgG/IgA, poor vaccine response, or specific antibody deficiency),
Elevated inflammatory biomarkers (e.g., CRP, cytokines),
No evidence of active infection (bacterial, viral, or fungal),
No comorbid neurological conditions (e.g., multiple sclerosis, Alzheimer's disease),
No current immunosuppressive therapies.
No investigational product will be administered by the study team. All treatments are prescribed and delivered independently by licensed international clinical sites. Healing Hope International operates as the sponsor and data coordinating center. Participants' data will be collected retrospectively and prospectively from site medical records, patient-reported surveys, and third-party laboratory assessments, including genetic testing for RXRA expression (e.g., via qPCR or NGS panels).
The primary data endpoints include:
Changes in immunological biomarkers (IgG/IgA, CRP, cytokine panel),
Clinical course of Long COVID symptoms (fatigue, cognitive impairment, respiratory issues),
Quality of life measures (collected via validated patient-reported outcome instruments).
The study complies with all applicable regulations for data protection and ethical research conduct, including informed consent, HIPAA-compliant data transfer where applicable, and de-identification of personal health information. Ethical approval will be obtained from an Institutional Review Board (IRB), and partner sites may obtain parallel local or national ethics approvals.
This study also seeks to characterize the broader landscape of medical tourism for regenerative therapies by mapping treatment accessibility, safety, and patient reported effectiveness in the context of international care. It does not replace or compete with regulated clinical trials but aims to generate actionable real world insights that can guide future controlled research.
By contributing to the body of evidence around global regenerative practices, this study supports the development of international ethical guidelines, compassionate use frameworks, and collaborative trial infrastructure in complex chronic conditions.
- Conditions
- Post-Acute Sequelae of SARS-CoV-2 Infection, Long COVID, Long COVID Fatigue, Long COVID Syndrome, COVID 19 Associated Coagulopathy, COVID-19 Vaccination
- Keywords
- Intranasal IVIG, Real-world data, Medical tourism, Long COVID fatigue, Cytokine panel, Immunoglobulin therapy, Brain fog, Chronic inflammation, Real-world evidence, Global health, Post-viral syndrome, Immune recovery
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long COVID Patients with Immunodeficiency | This group includes adult participants (ages 18-65) with a clinical diagnosis of Long COVID and laboratory-confirmed immunodeficiency (e.g., low IgG, low IgA, or specific antibody deficiency). Participants in this cohort are receiving intranasal immunoglobulin (IVIG) therapy as part of their standard care through international clinical sites. Data will be collected on treatment outcomes, cytokine and CRP profiles, antibody titers, and patient-reported symptoms including fatigue, cognitive function, and quality of life. No treatments are administered by the study team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue Severity Using the Fatigue Severity Scale (FSS) Using Patient-Reported Outcome Measures (PROMs)
Fatigue will be assessed using the Fatigue Severity Scale (FSS), a validated 9-item patient-reported outcome measure that evaluates the impact of fatigue on daily functioning. Each item is scored on a 7-point Likert scale. A decrease in total score from baseline indicates improvement.
Measured: Baseline and 12 Weeks
Change in Cognitive Dysfunction Using the Cognitive Failures Questionnaire (CFQ)
Cognitive dysfunction (often referred to as "brain fog") will be evaluated using the Cognitive Failures Questionnaire (CFQ), a validated 25-item instrument that measures the frequency of cognitive lapses in daily activities. Higher scores indicate greater impairment. Improvement is reflected by a decrease in score.
Measured: Baseline and 12 Weeks
Change in Breathlessness Using the Visual Analog Scale (VAS)
Breathlessness will be assessed using a Visual Analog Scale (VAS), in which participants rate their shortness of breath on a 100 mm line ranging from "no breathlessness" to "worst imaginable breathlessness." A lower score at 12 weeks compared to baseline indicates improvement.
Measured: Baseline and 12 Weeks
Secondary outcomes (3)
Change in C-Reactive Protein (CRP) Levels
Serum CRP levels will be collected at baseline and at 12 weeks to evaluate systemic inflammation. CRP is a sensitive marker of inflammatory activity. A reduction in CRP is considered a favorable outcome.
Measured: Baseline and 12 Weeks
Change in Pro-Inflammatory Cytokines (e.g., IL-6, TNF-α, IL-1β)
Plasma cytokine levels will be analyzed at baseline and 12 weeks using multiplex assays. Changes in IL-6, TNF-α, and IL-1β will be assessed as indicators of neuroinflammation and systemic immune activation. Decreases suggest treatment benefit.
Measured: Baseline and 12 Weeks
Change in Additional Cytokines and Inflammatory Markers
The following secondary cytokines and chemokines will also be tracked to evaluate the broader impact of intranasal IVIG on immune modulation. Reference ranges include:
- Interferon-beta (IFN-β): <20.0 pg/mL
- Interferon-gamma (IFN-γ): <60.0 pg/mL
- Interferon-alpha (IFN-α): <20.0 pg/mL
- Interleukin-10 (IL-10): <7.0 pg/mL
- IL-18: ≤468 pg/mL
- Monocyte Chemoattractant Protein-1 (MCP-1): ≤198 pg/mL
- Macrophage Inflammatory Protein-1 alpha (MIP-1α): <220 pg/mL
- Granulocyte-Monocyte Colony Stimulating Factor (GM-CSF): <15.0 pg/mL
- IL-2 Receptor Alpha Soluble (sIL-2Rα): ≤959 pg/mL
Changes in these markers will be analyzed to explore effects on neuroinflammatory signaling pathways, immune exhaustion, and cytokine resolution. Normalization trends will be documented and correlated with clinical improvements.
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Acute Sequelae of SARS-CoV-2 InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Tamara C Tamas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tamara C Tamas, Healing Hope International
- Investigators
- Dr. Anna Lara Kattan, MD: Regenerative Medicine, Principal investigator, StemSolutions.mx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992401
- Sponsor's protocol ID
- HH-IVIG-LC001
- Acronym
- IVIG-LC
- Status last verified
- Nov 2025
- First submitted
- 23 May 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Healing Hope International is currently evaluating options for secure and ethical data sharing in accordance with international data protection standards and participant consent. If IPD sharing becomes feasible, de-identified data may be made available to qualified researchers upon request and IRB approval. A final determination will be made after assessing data governance infrastructure and stakeholder input.
Publications
VanElzakker MB, Bues HF, Brusaferri L, Kim M, Saadi D, Ratai EM, Dougherty DD, Loggia ML. Neuroinflammation in post-acute sequelae of COVID-19 (PASC) as assessed by [11C]PBR28 PET correlates with vascular disease measures. Brain Behav Immun. 2024 Jul;119:713-723. doi: 10.1016/j.bbi.2024.04.015. Epub 2024 Apr 18.
PubMed 38642615Alaiya A, Alshukairi A, Shinwari Z, Al-Fares M, Alotaibi J, AlOmaim W, Alsharif I, Bakheet R, Alharbi L, Allam R, Asiri A, Memish Z, Alromaih K, Al-Mozaini M. Alterations in the Plasma Proteome Induced by SARS-CoV-2 and MERS-CoV Reveal Biomarkers for Disease Outcomes for COVID-19 Patients. J Inflamm Res. 2021 Sep 1;14:4313-4328. doi: 10.2147/JIR.S322430. eCollection 2021.
PubMed 34511970
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Collecting Real-World Data on Intranasal IVIG Treatment in Long COVID-19 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients With Immunodeficiency Engaged in International Medical Tourism
- ClinicalTrials.gov ID
- NCT06992401
- Acronym / sponsor ID
- IVIG-LC / HH-IVIG-LC001
- Conditions
- Post-Acute Sequelae of SARS-CoV-2 Infection, Long COVID, Long COVID Fatigue, Long COVID Syndrome, COVID 19 Associated Coagulopathy, COVID-19 Vaccination
- Keywords
- Intranasal IVIG, Real-world data, Medical tourism, Long COVID fatigue, Cytokine panel, Immunoglobulin therapy, Brain fog, Chronic inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tamara C TamasUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 28 May 2025 (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 observational study is being conducted by Healing Hope International to collect real-world data on an emerging treatment approach for Long COVID in patients with immunodeficiency. The study investigates the effects of intranasal immunoglobulin (IVIG) therapy in a real-world setting.
Participants will be individuals diagnosed with Long COVID who have confirmed immunodeficiency, such as low IgG or IgA levels or specific antibody deficiency. These individuals are receiving care through international clinical programs and will not receive any treatment as part of this study. Instead, Healing Hope will collect health information, clinical outcomes, and laboratory results from participating sites to better understand how intranasal IVIG might help reduce symptoms such as fatigue, brain fog, inflammation, and immune dysregulation.
The goal of this study is to contribute new insights into potential treatment options for Long COVID and to support responsible, science-backed care models for patients participating in medical tourism. No experimental drugs are being administered as part of this protocol. All treatment decisions are made independently by each clinical site. Data will be anonymized and used to advance knowledge in the field of immunological recovery and neuroinflammation.
Detailed description
This observational study, initiated by Healing Hope International, is designed to collect real-world data (RWD) from individuals diagnosed with Long COVID who are undergoing clinical care involving intranasal immunoglobulin (IVIG) therapy at international medical tourism sites.
Eligible participants are adults (ages 18-65) with:
Persistent Long COVID symptoms for ≥12 weeks following SARS-CoV-2 infection,
Laboratory-confirmed immunodeficiency (e.g., low IgG/IgA, poor vaccine response, or specific antibody deficiency),
Elevated inflammatory biomarkers (e.g., CRP, cytokines),
No evidence of active infection (bacterial, viral, or fungal),
No comorbid neurological conditions (e.g., multiple sclerosis, Alzheimer's disease),
No current immunosuppressive therapies.
No investigational product will be administered by the study team. All treatments are prescribed and delivered independently by licensed international clinical sites. Healing Hope International operates as the sponsor and data coordinating center. Participants' data will be collected retrospectively and prospectively from site medical records, patient-reported surveys, and third-party laboratory assessments, including genetic testing for RXRA expression (e.g., via qPCR or NGS panels).
The primary data endpoints include:
Changes in immunological biomarkers (IgG/IgA, CRP, cytokine panel),
Clinical course of Long COVID symptoms (fatigue, cognitive impairment, respiratory issues),
Quality of life measures (collected via validated patient-reported outcome instruments).
The study complies with all applicable regulations for data protection and ethical research conduct, including informed consent, HIPAA-compliant data transfer where applicable, and de-identification of personal health information. Ethical approval will be obtained from an Institutional Review Board (IRB), and partner sites may obtain parallel local or national ethics approvals.
This study also seeks to characterize the broader landscape of medical tourism for regenerative therapies by mapping treatment accessibility, safety, and patient reported effectiveness in the context of international care. It does not replace or compete with regulated clinical trials but aims to generate actionable real world insights that can guide future controlled research.
By contributing to the body of evidence around global regenerative practices, this study supports the development of international ethical guidelines, compassionate use frameworks, and collaborative trial infrastructure in complex chronic conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long COVID Patients with Immunodeficiency | – | –This group includes adult participants (ages 18-65) with a clinical diagnosis of Long COVID and laboratory-confirmed immunodeficiency (e.g., low IgG, low IgA, or specific antibody deficiency). Participants in this cohort are receiving intranasal immunoglobulin (IVIG) therapy as part of their standard care through international clinical sites. Data will be collected on treatment outcomes, cytokine and CRP profiles, antibody titers, and patient-reported symptoms including fatigue, cognitive function, and quality of life. No treatments are administered by the study team. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolls adults aged 18 to 65 with persistent Long COVID symptoms and confirmed immunodeficiency, including low IgG/IgA or poor vaccine response. Participants must have elevated inflammatory markers and be free of active infections or neurological conditions. The population is observed while undergoing intranasal IVIG therapy internationally, with a focus on immunological, genetic, and quality of life outcomes.
Key inclusion criteria (10 listed)
- Age 18 to 65 years
- Clinical diagnosis of Long COVID (symptoms persisting ≥12 weeks after SARS-CoV-2 infection)
- Laboratory-confirmed immunodeficiency, including one or more of the following:
- Low serum IgG and/or IgA
- Specific antibody deficiency
Key exclusion criteria (6 listed)
- Current or recent active infection (e.g., viral, bacterial, or fungal)
- Use of immunosuppressive therapy within the last 3 months
- Active infections: Participants with active infections, including viral, bacterial, or fungal infections, will be excluded
- Neurological disorders: Participants with diagnosed neurological disorders (e.g., multiple sclerosis, Parkinson's disease, Alzheimer's disease) will be excluded
- Immunosuppressive therapy: Participants receiving immunosuppressive therapy will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Fatigue Severity Using the Fatigue Severity Scale (FSS) Using Patient-Reported Outcome Measures (PROMs)
Time frame: Baseline and 12 Weeks
Fatigue will be assessed using the Fatigue Severity Scale (FSS), a validated 9-item patient-reported outcome measure that evaluates the impact of fatigue on daily functioning. Each item is scored on a 7-point Likert scale. A decrease in total score from baseline indicates improvement.
Change in Cognitive Dysfunction Using the Cognitive Failures Questionnaire (CFQ)
Time frame: Baseline and 12 Weeks
Cognitive dysfunction (often referred to as "brain fog") will be evaluated using the Cognitive Failures Questionnaire (CFQ), a validated 25-item instrument that measures the frequency of cognitive lapses in daily activities. Higher scores indicate greater impairment. Improvement is reflected by a decrease in score.
Change in Breathlessness Using the Visual Analog Scale (VAS)
Time frame: Baseline and 12 Weeks
Breathlessness will be assessed using a Visual Analog Scale (VAS), in which participants rate their shortness of breath on a 100 mm line ranging from "no breathlessness" to "worst imaginable breathlessness." A lower score at 12 weeks compared to baseline indicates improvement.
3 secondary outcomes
Change in C-Reactive Protein (CRP) Levels
Time frame: Baseline and 12 Weeks
Change in Pro-Inflammatory Cytokines (e.g., IL-6, TNF-α, IL-1β)
Time frame: Baseline and 12 Weeks
Change in Additional Cytokines and Inflammatory Markers
Time frame: Baseline and 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 38642615VanElzakker MB, Bues HF, Brusaferri L, Kim M, Saadi D, Ratai EM, Dougherty DD, Loggia ML. Neuroinflammation in post-acute sequelae of COVID-19 (PASC) as assessed by [11C]PBR28 PET correlates with vascular disease measures. Brain Behav Immun. 2024 Jul;119:713-723. doi: 10.1016/j.bbi.2024.04.015. Epub 2024 Apr 18.
- Background: PubMed 34511970Alaiya A, Alshukairi A, Shinwari Z, Al-Fares M, Alotaibi J, AlOmaim W, Alsharif I, Bakheet R, Alharbi L, Allam R, Asiri A, Memish Z, Alromaih K, Al-Mozaini M. Alterations in the Plasma Proteome Induced by SARS-CoV-2 and MERS-CoV Reveal Biomarkers for Disease Outcomes for COVID-19 Patients. J Inflamm Res. 2021 Sep 1;14:4313-4328. doi: 10.2147/JIR.S322430. eCollection 2021.
- Individual participant dataSharing planned: Undecided. Healing Hope International is currently evaluating options for secure and ethical data sharing in accordance with international data protection standards and participant consent. If IPD sharing becomes feasible, de-identified data may be made available to qualified researchers upon request and IRB approval. A final determination will be made after assessing data governance infrastructure and stakeholder input.
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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.
Dr. Anna Lara Kattan, MD: Regenerative Medicine principal investigator
StemSolutions.mx
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Acute Sequelae of SARS-CoV-2 Infection and Long COVID, run by Tamara C Tamas.
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 10 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa J Orsic, Patient Coordinator (+1 847 766-4580, info@horizonsthinktank.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Severity Using the Fatigue Severity Scale (FSS) Using Patient-Reported Outcome Measures (PROMs) (time frame: Baseline and 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?
On the ClinicalTrials.gov record for NCT06992401, which also lists 2 linked publications.
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 2 Dec 2025.