Status:
ENROLLING_BY_INVITATION
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Systemic Inflammation
Neuroinflammation
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Study Description: This study will evaluate the clinical and laboratory effects of immunoglobulin therapy in patients who recovered from acute mild-moderate COVID-19 infection but still have persiste...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05350774
Start Date
July 10 2023
End Date
December 15 2026
Last Update
January 2 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892