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

NCT06992401 | Not Yet Recruiting

• 1 other identifier: HH-IVIG-LC001
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Intranasal IVIG; Real-world data; Medical tourism; Long COVID fatigue; Cytokine panel; Immunoglobulin therapy; Brain fog; Chronic inflammation; Real-world evidence; Global health; Post-viral syndrome; Immune recovery

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and 12 Weeks

• 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.

  Baseline and 12 Weeks

• 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.

  Baseline and 12 Weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tamara C Tamas: lead

Related Publications (2)

• VanElzakker MB, Bues HF, Brusaferri L, Kim M, Saadi D, Ratai EM, Dougherty DD, Loggia ML. Neuroinflammation in post-acute sequelae of COVID-19 (PASC) as assessed by [11C]PBR28 PET correlates with vascular disease measures. Brain Behav Immun. 2024 Jul;119:713-723. doi: 10.1016/j.bbi.2024.04.015. Epub 2024 Apr 18.

  PMID: 38642615 BACKGROUND

• Alaiya A, Alshukairi A, Shinwari Z, Al-Fares M, Alotaibi J, AlOmaim W, Alsharif I, Bakheet R, Alharbi L, Allam R, Asiri A, Memish Z, Alromaih K, Al-Mozaini M. Alterations in the Plasma Proteome Induced by SARS-CoV-2 and MERS-CoV Reveal Biomarkers for Disease Outcomes for COVID-19 Patients. J Inflamm Res. 2021 Sep 1;14:4313-4328. doi: 10.2147/JIR.S322430. eCollection 2021.

  PMID: 34511970 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Mental Fatigue

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Dr. Anna Lara Kattan, MD: Regenerative Medicine

  StemSolutions.mx

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa J Orsic, Patient Coordinator

CONTACT

+1 847 766-4580; info@horizonsthinktank.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Regulatory Affairs

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: May 28, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11