NCT05350774
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Enrolling by Invitation
PHASE2Ages 18+InterventionalTreatmentNational Institute of Neurological Disorders and Stroke (NINDS)Government-funded
~45 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:IV normal salineIV immunoglobulin
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effects of intravenous immunoglobulin therapy
Measured over 2 weeks
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Avindra Nath, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, aged at least 18 and older.
Previously diagnosed with mild-moderate COVID-19 (WHO Clinical Progression Scale between 2-5. Patients with severe acute COVID-19 requiring hospitalization or ICU care are excluded. Enrollment could take place 12 weeks after the diagnosis of acute COVID-19.
Prior COVID-19 diagnosis confirmed by patient reported infection followed by confirmatory nucleocapsid antibody testing or a positive SARS-CoV-2 PCR test result from the time of infection.
Exhibiting persistent neurologic symptoms evidenced by a self-reported illness narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 infection. These include symptoms such as fatigue, cognitive difficulties, orthostatic intolerance, and any ongoing issues with gait instability, vision, speech, swallowing, sensation or strength.
Non-negligible PASC symptom severity, as determined using PCFS (minimal score of 2).
Ability of subject to understand and the willingness to sign a written informed consent document.
Prior completion of a clinical brain MRI after the diagnosis of COVID-19, or willingness to complete a brain MRI.
Meets current Clinical Center HES' policy for discontinuing isolation and quarantine for COVID-19.
Exclusion
Contraindication to a research lumbar puncture, including use of anticoagulant medication, platelets \< 50,000/uL, PT or PTT \>1.5 x ULN for the NIH Clinical Center, or otherwise inability to complete the procedure.
A condition that would significantly confound interpretation of the clinical and research tests as determined by the study investigators. This could include: traumatic brain injury, substance use disorder, active malignancy, systemic immunologic disorders, current or previous long-term immune suppressive therapy.
Received a SARS-CoV-2 vaccine dose within less than 4 weeks of enrollment or is planning for any additional vaccines during the course of the study.
Prior experimental treatment for PASC with immunoglobulins.
Current medications include oral steroids or other immunosuppressive medications.
Active participation in a clinical protocol which includes any intervention that may affect the results of the current study.
Contraindication of intravenous immunoglobulins, including:
Renal insufficiency (eGFR\<45mmol/L)
IgA deficiency
History of ischemic heart disease
Peripheral vascular disease
Cerebrovascular disease
Previously diagnosed hypercoagulability syndrome including antiphospholipid antibody syndrome, Protein C/S deficiency, Factor V Leiden, Antithrombin deficiency, MTHFR homozygosity
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3.0 times the upper limit of normal.precluding the use of acetaminophen.
Previously documented anaphylaxis or severe systemic reaction to immunoglobulins, acetaminophen, or diphenhydramine.
A severe psychiatric condition, which based on the assessment of the study investigators, will impact the ability to complete the 12-week study course.
What this trial measures
- Effects of intravenous immunoglobulin therapy2 weeks
Comparison of proportion of participants with a clinically meaningful change in Health Utilities Index Mark 3 (HUI3) after receiving either IVIg or placebo at Week 2.