Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT05350774
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Microvascular Thrombosis
  • Neuroinflammation
  • Systemic Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • IV normal saline — DRUG
    IV normal saline 250ml for 5 days
  • IV immunoglobulin — DRUG
    IVIg - IV immunoglobulin 0.4g/kg/day for 5 days

Study Details

Background: COVID-19 can cause problems in different parts of the body. For most people, it causes fevers or trouble breathing. Some people might not recover all the way. Researchers want to see if a treatment can help with people who have recovered from COVID-19 but still have symptoms ("Long COVID"). Objective: To learn if human immunoglobulin (IVIG) will help with neurological symptoms of Long COVID. Eligibility: Adults ages 18 and older who had COVID-19 at least 12 weeks ago and have ongoing neurologic symptoms, such as dizziness, trouble walking, or problems with strength. Design: Participants will be screened with a medical record review. Participants will have a medical history and a physical exam and complete questionnaires about their health and quality of life. They will have a spinal tap. They will give blood samples. They will discuss their symptoms with a neurologist and have a neurological exam. Participants will take memory and thinking tests using a tablet. The tests will take 1 hour to complete. They will also take a smell and taste test. It will take approximately 30 minutes to complete. Participants will lie on a table that tilts for up to 40 minutes. Their blood pressure and heart rate will be monitored. Blood will be taken through an intravenous (IV) catheter. Participants will receive either IVIG, or saline by IV for 5 days. Then the participants will receive IVIG if they first received saline or saline if they first received IVIG by IV for another 5 days. They will not know what they receive. Participants will have an MRI of the brain if they have not had one recently. They will receive a contrast agent by IV as part of the MRI scan. Participants will be on the study for up to 4 months. They will have follow-up visits at the clinical center as well as fill out questionnaires at home. They may be asked to continue follow-up.

Key Dates

Start date
Jul 10, 2023
Status verified
Jun 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IVIg arm
    IVIg arm IV immunoglobulin 0.4g/kg/day for 5 days
  • Placebo Comparator: Placebo arm
    equivalent volume of Normal Saline for 5 days

Primary Outcome Measure

Effects of intravenous immunoglobulin therapy [ Time Frame: 2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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