Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
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|ClinicalTrials.gov Identifier: NCT05350774|
Recruitment Status : Enrolling by invitation
First Posted : April 28, 2022
Last Update Posted : December 5, 2022
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 2 treatments can help with people who have recovered from COVID-19 but still have symptoms ( Long-Haul COVID ).
To learn if methylprednisolone (steroid) and human immunoglobulin (IVIG) will help with symptoms of Long-Haul COVID.
Adults ages 18 and older who had COVID-19 at least 6 weeks ago and have ongoing neurologic symptoms, such as dizziness, trouble walking, or problems with strength.
Participants will be screened with a medical record review.
Participants will have a physical exam and chest x-ray. They will 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 an exam.
Participants will take memory and thinking tests using pen and paper. The tests will take 10-15 minutes to complete. They will also take a smell test with scratch-and-sniff books. It will take 5-10 minutes to complete.
Participants will lie on a table that tilts. Their blood pressure and heart rate will be monitored. Blood will be taken through an intravenous (IV) catheter.
Participants will receive either the steroid, IVIG, or saline by IV for 5 days. They will not know which treatment they get.
Participants may have an optional MRI of the brain and spine. They will receive a contrast agent by IV.
Participants will be on the study for up to 3 months. They may be asked to continue follow-up.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Inflammation Neuroinflammation Microvascular Thrombosis||Drug: IV immunoglobulin Drug: IV normal saline Drug: IV methylprednisolone||Phase 2|
This study will evaluate the clinical and laboratory effects of immunotherapies in patients who recovered from acute mildmoderate COVID-19 infection but still have persistent neurologic symptoms. Despite clinical recovery from the acute infection, some individuals continue to experience ongoing symptoms, at times several months after recovery, and many of these symptoms are neurologic. Some features suggest that this is a post-infectious immune-mediated process, and anecdotally patients have responded well to immunotherapies. This study will evaluate the clinical and laboratory effects of the different proposed immunological interventions compared to placebo. It is hypothesized that these interventions could have positive clinical and laboratory effects on patients with persistent neurological symptoms.
Primary Objective: To compare the clinical effects of three study arms (intravenous immunoglobulin, intravenous steroids, or placebo) in participants with neurological post-acute sequalae of SARS-CoV-2 infection.
Secondary objective: To investigate laboratory effects of immunotherapies in patients with neurological post-acute sequalae of SARS-CoV-2 infection.
Proportion of participants with a clinically meaningful change in Health Utilities Index Mark 3 (HUI3) 4 weeks after study intervention
Change in functional / patient-reported scales:
- WHO post COVID-19 functional scale
- Post-COVID-19 Functional Status (PCFS) scale (0-4).
- COVID-19 Yorkshire Rehabilitation Scale
- PROMIS Global Health score
- PROMIS Depression score
- PROMIS anxiety score
Change in clinical scales:
- Montreal Cognitive Assessment (MoCA)
- Brief tablet-based Neuropsychiatric evaluation
- Karnofsky Performance Status (KPS)
- University of Pennsylvania Smell Identification Test (UPSIT)
- Autonomic testing - Change in the number and character of test results indicating autonomic nervous system dysfunctions as evidenced by abnormal physiological and neurochemical measures at rest or in responses to the Valsalva maneuver or head-up tilting.
Change in immunological markers:
- Cytokine levels
- Cell markers per flow cytometry
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2 (IN-PASC)|
|Estimated Study Start Date :||December 8, 2022|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: IVIg arm
IVIg arm IV immunoglobulin 0.4g/kg/day for 5 days
Drug: IV immunoglobulin
IVIg IV immunoglobulin 0.4g/kg/day for 5 days
Placebo Comparator: Placebo arm
IV normal saline 250ml for 5 days
Drug: IV normal saline
IV normal saline 250ml for 5 days
Experimental: Steroid arm
Steroid arm IV methylprednisolone 1g/day for 5 days
Drug: IV methylprednisolone
Steroid - IV methylprednisolone 1g/day for 5 days
- Effects of immunotherapies in patients [ Time Frame: 4 weeks after treatment ]The primary outcome measure is the proportion of participants with a clinically meaningful improvement in Health Utilities Index Mark 3 (HUI3) 4 weeks after study intervention.
- Investigate laboratory effects [ Time Frame: 4 weeks after treatment ]To investigate laboratory effects of immunotherapies in patients with neurological post-acute sequelae of SARS-CoV-2 infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05350774
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Avindra Nath, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|