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.
Age 18 to 65 years
Clinical diagnosis of Long COVID (symptoms persisting ≥12 weeks after SARS-CoV-2 infection)
Low serum IgG and/or IgA
Specific antibody deficiency
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
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.
Cohort
Prospective
Not listed
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.
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.
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.
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.
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.
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.
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Tamara C Tamas
Lead sponsor
Healing Hope International
Sponsor institution
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