Could an immune treatment ease long COVID brain fog?
NCT ID NCT05350774
First seen Jun 24, 2026 · Last updated Aug 27, 2026 · Updated 19 times
Summary
This study tests whether a treatment called IVIG (intravenous immunoglobulin) can help with ongoing neurological symptoms after COVID-19, like dizziness, trouble walking, or memory problems. About 45 adults who had COVID-19 at least 12 weeks ago will receive either IVIG or a placebo (saline) for 5 days, then switch to the other. Researchers will check if symptoms improve after two weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IV immunoglobulin (IVIG)
- What this could lead to
- If it works, this could point toward a treatment for neurological Long COVID symptoms, such as dizziness and memory problems.
- What could go wrong
- This is a small, early-stage trial with only 45 participants, so results may not apply to everyone. IVIG can cause side effects like headache or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2023
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * 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. * Meets the inclusion/exclusion criteria and is enrolled in Phase A of Protocol 000089 "Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health." * 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 CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: \- For participants who have not completed a brain MRI since onset of symptoms: inability to complete brain MRI with gadolinium including contraindicated metal in the body, prior allergic reaction to gadolinium, eGFR \<45 mmol/L, pregnancy or lactation, or claustrophobia that is unable to be adequately treated with a low dose oral benzodiazepine. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Microvascular thrombosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gentler Heart-Lung machine may mean less Post-Surgery inflammation
- Can a spoonful of yoghurt calm the Body's fire in the ICU?
- Can a PET tracer reveal hidden brain inflammation?
- Could cleaning the gums protect a transplanted heart?
- Could everyday vitamins tame brain inflammation linked to obesity?
- Antioxidant-rich diets may fight inflammation in type 2 diabetes — a study investigates