Steroid arm for Neuroinflammation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Neuroinflammation+4 More
IV methylprednisolone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Neuroinflammation
  • Microvascular Thrombosis
  • Systemic Inflammation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 4 weeks after treatment

4 weeks after treatment
Effects of immunotherapies in patients
Investigate laboratory effects

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Steroid arm
1 of 3
IVIg arm
1 of 3
Placebo arm
1 of 3
Experimental Treatment
Non-Treatment Group

60 Total Participants · 3 Treatment Groups

Primary Treatment: Steroid arm · Has Placebo Group · Phase 2

Steroid arm
Drug
Experimental Group · 1 Intervention: IV methylprednisolone · Intervention Types: Drug
IVIg arm
Drug
Experimental Group · 1 Intervention: IV immunoglobulin · Intervention Types: Drug
Placebo arm
Drug
PlaceboComparator Group · 1 Intervention: IV normal saline · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks after treatment
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
2016First Recorded Clinical Trial
1 TrialsResearching Neuroinflammation
270 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been infected with COVID-19 and you have antibodies to the virus
You meet the current HES policy for discontinuing isolation and quarantine for COVID-19.
You are willing to comply with all study procedures and are available for the duration of the study.
You have been previously diagnosed with mild-moderate COVID-19 (WHO Clinical Progression Scale between 2-5)
You have at least 2 of the following symptoms: fatigue, muscle pain, or tenderness in your joints.
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent document.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.