Pembrolizumab for Long COVID Syndrome

Overseen By Avindra Nath, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Must not be taking: Oral steroids, Immunosuppressives

Disqualifiers: Severe psychiatric condition, Active malignancy, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 7

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

Background:

SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from an acute COVID-19 infection may continue to have symptoms that persist for months or years. These can include neurological symptoms, such as headaches, loss of taste or smell, dizziness, or trouble walking. Pembrolizumab is a drug approved to treat certain cancers. Researchers think this drug might reduce long-term neurologic symptoms after a COVID-19 infection.

Objective:

To test pembrolizumab in people with ongoing neurologic symptoms of COVID-19.

Eligibility:

People aged 18 years or older who had COVID-19 at least 6 months ago and have ongoing neurologic symptoms.

Design:

Participants will have 7 clinic visits in 7 months.

Participants will be screened. They will have a physical exam with blood tests. Swabs will be used to collect cells from inside the mouth and nose. They may opt to have an imaging scan.

Participants will also have other tests before they are given the study drug. These include eye and skin exams; tests of their memory and thinking; and tests of involuntary body functions, such as heart rate, blood pressure, sweating, and digestion. Their grip strength and walking pace will be measured. They will wear a heart rate monitor for 24 hours. They will wear devices on a wrist and thigh to measure activity for 10 days.

Participants will have a lumbar puncture (spinal tap): A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.

Pembrolizumab is given through a needle inserted into a vein. Participants will receive 1 dose of the drug.

Participants will have 4 follow-up visits over 6 months. Tests may be repeated during these visits.

Who Is on the Research Team?

Avindra Nath, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Are You a Good Fit for This Trial?

This trial is for adults over 18 who had COVID-19 at least six months ago and are now experiencing ongoing neurological symptoms like headaches, loss of taste or smell, dizziness, or trouble walking.

Inclusion Criteria

I am 18 years old or older.

Participants of childbearing potential must agree to use a combination of contraception or have had surgical sterilization, from the time of enrollment until 4 months after the dose of study drug

Participants capable of sperm donation must agree to not donate sperm from the time of enrollment until 4 months after the dose of study drug

Exclusion Criteria

My symptoms prevent me from traveling to NIH.

For participants who have not completed a brain MRI since onset of symptoms: inability to complete brain MRI with gadolinium including contraindicated metal in the body, prior allergic reaction to gadolinium, eGFR <45 mmol/L, or claustrophobia that is unable to be adequately treated with a low dose oral benzodiazepine

I cannot have a spinal tap due to certain health risks or conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Treatment Assessment

Participants undergo various tests including physical exams, blood tests, imaging scans, and neurological assessments before receiving the study drug

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of Pembrolizumab 200 mg intravenously

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with tests potentially repeated during follow-up visits

6 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab

Trial Overview

The trial is testing Pembrolizumab, a cancer drug thought to potentially reduce long-term neurological symptoms post-COVID. Participants will receive one dose through an IV and undergo various tests including physical exams, blood tests, imaging scans, memory assessments, and activity measurements over seven visits in seven months.

How Is the Trial Designed?

Group I: Open Label Experimental Treatment 1 Intervention

Single dose of Pembrolizumab 200 mg IV

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+