NCT06992401Not yet recruiting
Observational Study of Intranasal IVIG in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients Undergoing Medical Tourism
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
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 23 May 2025
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Tamara C Tamas
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06992401
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Aug 2026 to the primary completion date, 1 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of immunosuppressive therapy within the last 3 months
- Immunosuppressive therapy: Participants receiving immunosuppressive therapy will be excluded
Other illness
- Current or recent active infection (e.g., viral, bacterial, or fungal)
- 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
Other
- Inability to comply with study assessments or procedures
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.