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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Change in Fatigue Severity Using the Fatigue Severity Scale (FSS) Using Patient-Reported Outcome Measures (PROMs)
研究概览
简要总结
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.
详细描述
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),
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Fatigue Severity Using the Fatigue Severity Scale (FSS) Using Patient-Reported Outcome Measures (PROMs)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Change in C-Reactive Protein (CRP) Levels(Baseline and 12 Weeks)
- Change in Pro-Inflammatory Cytokines (e.g., IL-6, TNF-α, IL-1β)(Baseline and 12 Weeks)
- Change in Additional Cytokines and Inflammatory Markers(Baseline and 12 Weeks)
研究者
Tamara C Tamas
Director of Regulatory Affairs
Healing Hope International