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

Ki nem vehet részt

• 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
• 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
• 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
• 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
• An individual who meets any of the following criteria will be excluded from participation in this study:
• Active participation in a clinical protocol which includes any intervention that may affect the results of the current study

Egyéb feltételek

• 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