Trial Summary
What is the purpose of this trial?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 treatment can help with people who have recovered from COVID-19 but still have symptoms ("Long COVID").
Objective:
To learn if human immunoglobulin (IVIG) will help with neurological symptoms of Long COVID.
Eligibility:
Adults ages 18 and older who had COVID-19 at least 12 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 medical history and a physical exam and 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 a neurological exam.
Participants will take memory and thinking tests using a tablet. The tests will take 1 hour to complete. They will also take a smell and taste test. It will take approximately 30 minutes to complete.
Participants will lie on a table that tilts for up to 40 minutes. Their blood pressure and heart rate will be monitored. Blood will be taken through an intravenous (IV) catheter.
Participants will receive either IVIG, or saline by IV for 5 days. Then the participants will receive IVIG if they first received saline or saline if they first received IVIG by IV for another 5 days. They will not know what they receive.
Participants will have an MRI of the brain if they have not had one recently. They will receive a contrast agent by IV as part of the MRI scan.
Participants will be on the study for up to 4 months. They will have follow-up visits at the clinical center as well as fill out questionnaires at home. They may be asked to continue follow-up....
Eligibility Criteria
Adults over 18 who had mild to moderate COVID-19 at least 12 weeks ago and are now experiencing persistent neurological symptoms like dizziness, cognitive issues, or walking difficulties. They must be willing to follow the study procedures for up to 4 months and have a brain MRI if they haven't already. People with severe psychiatric conditions, recent vaccines, certain medical treatments or conditions that could affect results are excluded.Inclusion Criteria
Enrolled in the screening phase of Protocol 000089 Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
I have had or am willing to have a brain MRI after being diagnosed with COVID-19.
I had COVID-19 but it was not severe enough to need hospital or ICU care.
+7 more
Exclusion Criteria
You cannot have a brain MRI with a contrast agent if you have metal in your body, kidney function below a certain level, are pregnant or breastfeeding, or have severe claustrophobia.
You have certain medical conditions like kidney problems, heart disease, blood clotting disorders, severe allergies, or psychiatric conditions that make it unsafe for you to receive intravenous immunoglobulins.
I cannot have a spinal tap due to certain health issues or medications.
+6 more
Participant Groups
The trial is testing whether IV immunoglobulin (IVIG), compared to saline solution (a placebo), can improve long-term neurological symptoms after COVID-19 recovery. Participants will receive both treatments in different periods without knowing which one they're getting first.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IVIg armExperimental Treatment1 Intervention
IVIg arm IV immunoglobulin 0.4g/kg/day for 5 days
Group II: Placebo armPlacebo Group1 Intervention
equivalent volume of Normal Saline for 5 days
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor