This observational study is being conducted by Healing Hope International to collectreal-world data on an emerging treatment approach for Long COVID in patients withimmunodeficiency. The study explores the relationship between the RXRA gene andneuroinflammation and investigates the effects of intranasal immunoglobulin (IVIG)therapy in a real-world setting.Participants will be individuals diagnosed with Long COVID who have confirmedimmunodeficiency, such as low IgG or IgA levels or specific antibody deficiency. Theseindividuals are receiving care through international clinical programs and will notreceive any treatment as part of this study. Instead, Healing Hope will collect healthinformation, clinical outcomes, and laboratory results from participating sites to betterunderstand how intranasal IVIG might help reduce symptoms such as fatigue, brain fog,inflammation, and immune dysregulation.The RXRA gene plays a role in regulating inflammation and immune response. Participantswill also undergo genetic testing to assess RXRA expression and explore how it may belinked to recovery or ongoing symptoms.The goal of this study is to contribute new insights into potential treatment options forLong COVID and to support responsible, science-backed care models for patientsparticipating in medical tourism. No experimental drugs are being administered as part ofthis protocol. All treatment decisions are made independently by each clinical site. Datawill be anonymized and used to advance knowledge in the field of immunological recoveryand neuroinflammation.
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. The objective is to better understand the relationship between RXRA gene
expression and neuroinflammatory processes in immunodeficient individuals, and to
evaluate the real-world impact of intranasal IVIG as a supportive therapy.
The RXRA gene encodes a nuclear receptor that regulates gene transcription involved in
inflammation, lipid metabolism, and immune response modulation. Dysregulation of RXRA
expression has been linked to inflammatory and neurodegenerative disorders. By
correlating RXRA expression levels with immunological and symptomatic outcomes in a Long
COVID population, this study seeks to clarify its relevance in chronic post-viral
inflammation.
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:
RXRA gene expression levels,
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.
The results of this study may help clarify the potential role of RXRA as a biomarker for
neuroinflammation and assess the feasibility of intranasal IVIG as an adjunctive therapy
for immune dysfunction in post-viral syndromes. 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.
Inclusion Criteria:
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
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
Exclusion Criteria:
1. Current or recent active infection (e.g., viral, bacterial, or fungal)
2. Use of immunosuppressive therapy within the last 3 months
3. Active Infections: Participants with active infections, including viral, bacterial,
or fungal infections, will be excluded.
4. Neurological Disorders: Participants with diagnosed neurological disorders, such as
multiple sclerosis, Parkinson's disease, or Alzheimer's disease, will be excluded.
5. Immunosuppressive Therapy: Participants receiving immunosuppressive therapy will be
excluded.
6. Inability to comply with study assessments or procedures
Not Provided
Tamara C Tamas, MS. Biopharmaceutical RA
18633545131
tamara.c.tamas@gmail.com
Lisa J Orsic, Patient Coordinator
1-847-766-4580
Mslisaski@yahoo.com
Dr. Anna L Kattan, MD: Regenerative Medicine, Principal Investigator
StemSolutions