Observational Study of Intranasal IVIG in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients Undergoing Medical Tourism

Sponsor
Tamara C Tamas
Study ID
NCT06992401
Status
Not Yet Recruiting

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Conditions

  • COVID 19 Associated Coagulopathy
  • COVID-19 Vaccination
  • Long COVID
  • Long COVID Fatigue
  • Long COVID Syndrome
  • Post-Acute Sequelae of SARS-CoV-2 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 28, 2025
Start date
Aug 1, 2026
Status verified
Nov 2025
Primary completion
Jan 1, 2029
Completion
Jul 15, 2029

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.

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 ]

Central Contacts

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