Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
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 2
treatments can help with people who have recovered from COVID-19 but still have symptoms (
Long-Haul COVID ).
Objective:
To learn if methylprednisolone (steroid) and human immunoglobulin (IVIG) will help with
symptoms of Long-Haul COVID.
Eligibility:
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.
Design:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)