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Immunoglobulin
Immunotherapy for Long-Haul COVID
Phase 2
Waitlist Available
Led By Avindra Nath, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Non-negligible PASC symptom severity, as determined using PCFS (minimal score of 2)
Must not have
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
Current medications include oral steroids or other immunosuppressive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Summary
This trial is testing if 2 treatments - methylprednisolone (steroid) and human immunoglobulin (IVIG) - can help with symptoms of Long-Haul COVID in adults who had the virus at least 6 weeks ago.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of IVIG include allergic reactions, kidney dysfunction, blood clots, and low-grade fever. Saline solution is generally safe but may cause discomfort at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had COVID-19 but it was not severe enough to need hospital or ICU care.
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I experience significant long COVID symptoms.
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I had COVID-19 confirmed by a test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have a spinal tap due to certain health issues or medications.
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I am currently taking oral steroids or other medications that suppress my immune system.
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I don't have severe heart issues or take daily medication that affects nerve tests.
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I have tried experimental treatments for PASC with immunoglobulins.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effects of intravenous immunoglobulin therapy
Secondary study objectives
Investigate laboratory effects
Trial Design
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 Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,376 Previous Clinical Trials
651,440 Total Patients Enrolled
Avindra Nath, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
12 Previous Clinical Trials
5,615 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.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.I am currently taking oral steroids or other medications that suppress my immune system.I don't have severe heart issues or take daily medication that affects nerve tests.You have a medical condition or history that could make it hard to understand the study results, such as a brain injury, substance abuse problem, cancer, immune system disorder, or long-term immune system treatment.I experience significant long COVID symptoms.I have long-lasting symptoms like fatigue or memory issues after recovering from COVID-19.I got a COVID-19 vaccine less than 4 weeks ago or plan to during the study.I am 18 years old or older.I have tried experimental treatments for PASC with immunoglobulins.I am willing and able to follow the study's procedures and be available for its duration.I had COVID-19 confirmed by a test.
Research Study Groups:
This trial has the following groups:- Group 1: IVIg arm
- Group 2: Placebo arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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