Pembrolizumab for Long COVID Syndrome

LN
AN
Overseen ByAvindra Nath, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether pembrolizumab, a drug typically used for certain cancers, can reduce long-term neurological symptoms in people who have recovered from COVID-19. These symptoms might include ongoing issues like headaches, dizziness, or trouble with walking. The trial seeks individuals who had COVID-19 at least six months ago and still experience these persistent neurological problems. Participants will receive one dose of the drug and attend seven clinic visits over seven months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on oral steroids or other immunosuppressive medications that could affect the study's outcome. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

Research has shown that pembrolizumab, a drug approved for treating some cancers, is under study for its potential to alleviate long-term neurological symptoms after COVID-19. In past studies with cancer patients, most tolerated pembrolizumab well, with few experiencing serious side effects. Some reported mild to moderate issues like tiredness or nausea.

This trial is in an early safety phase, meaning that while the drug is being tested for new uses, safety information for this specific condition is still being gathered. Although pembrolizumab is approved for other conditions, indicating it might be safe, participants should be aware that new side effects could still emerge in this trial.12345

Why do researchers think this study treatment might be promising?

Pembrolizumab is unique because it targets the immune system differently from current treatments for Long COVID. Most existing treatments focus on managing symptoms, like fatigue and brain fog, or addressing inflammation with steroids. Pembrolizumab, however, is a monoclonal antibody that works by blocking a specific protein called PD-1, which helps activate the immune system to fight lingering effects of the virus. Researchers are excited because this approach could offer a more targeted way to address the underlying immune dysfunction in Long COVID, potentially leading to more effective and longer-lasting relief for patients.

What evidence suggests that pembrolizumab might be an effective treatment for Long COVID?

Research suggests that pembrolizumab, a drug approved for treating certain cancers, might help reduce long-term neurological symptoms caused by COVID-19. Although no direct proof exists yet for its use in Long COVID, the drug aids the immune system in addressing ongoing issues. This is important because some Long COVID symptoms may result from continuous immune responses. Early studies in other conditions have shown that pembrolizumab can alter immune system function, which is why researchers are considering it here. In cancer treatment, it has helped stabilize the disease, indicating it might also manage ongoing symptoms. Participants in this trial will receive a single dose of pembrolizumab 200 mg IV to evaluate its potential benefits for Long COVID.12356

Who Is on the Research Team?

AN

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
See 11 more

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.
See 9 more

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?

1

Treatment groups

Experimental Treatment

Group I: Open LabelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials
1,403
Recruited
655,000+

Citations

Phase I Open-Label Safety Trial of Pembrolizumab for ...

Researchers think this drug might reduce long-term neurologic symptoms after a COVID-19 infection. Objective: To test pembrolizumab in people ...

Clinical Outcomes in COVID-19 Patients Treated with ... - PMC

This is evidenced by data showing that the estimated risk of infection from SARS-CoV-2 with severe or fatal complications is approximately 2.3 ...

NCT05350774 | Immunotherapy for Neurological Post- ...

This study will evaluate the clinical and laboratory effects of immunoglobulin therapy in patients who recovered from acute mild-moderate COVID-19 infection

COVID-19 infection during treatment with pembrolizumab ...

The use of pembrolizumab with chemotherapy in first-line treatment of patients with advanced NSCLC may lead to remission or stabilization of the disease.

Post COVID-19 pandemic Inflammatory Insights into Cancer

The post-pandemic era presents a pressing need to elucidate the long-term immunological consequences of SARS-CoV-2 infection and vaccination in cancer patients, ...

Impact of COVID-19 Pandemic on Frontline Pembrolizumab ...

Third, SARS-CoV-2 infection can modulate immune response, and this may alter the safety or the efficacy of pembrolizumab-based treatment [9,10].