Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)

Starting soon · Phase 1

Conditions studied: Post-Acute COVID-19 Syndrome

In brief

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.

Key facts

Study ID

NCT07388550

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

15

Starts

2026-08-13

Expected to finish

2028-01-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.
• 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, if risk of lumbar puncture is increased for other reasons such as space occupying lesion, skin infection at site of the puncture or otherwise inability to complete the procedure.
• A condition that would significantly confound interpretation of the clinical and research tests as determined by the study investigators. This could include traumatic brain injury, substance use disorder, active malignancy, systemic immunologic disorders, current or previous long-term immune suppressive therapy.
• Any premorbid medical condition that would potentially cause fatigue and exercise intolerance. This includes many chronic medical diseases, such as congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe arthritis, uncontrolled asthma, renal failure, fibromyalgia, and ME/CFS.
• Symptom severity that makes it impossible for the participant to travel to NIH.
• Received a SARS-CoV-2 vaccine dose within less than 4 weeks of enrollment or is planning for any additional vaccines during the study.
• Prior treatment for PASC with immunomodulatory therapies such as check point inhibitors which in the opinion of the investigators could impact the outcome of this study.
• Current medications include oral steroids or other immunosuppressive medications which in the opinion of the investigators could impact the outcome of this study.
• Active participation in a clinical protocol which includes any intervention that may affect the results of the current study.
• Abnormal anti-thyroid panel (anti-TPO and anti-TG) test at screening visit.
• ANA titer of 1:80 or greater, positive anti-CCP.
• Abnormal screening blood tests exceeding any of the limits defined below or as deemed exclusionary by the investigators on review at baseline:
• Aspartate aminotransferase and alanine aminotransferase values >2x upper limit of normal precluding the use of acetaminophen
• Fasting triglyceride > 300 mg/dL.
• Total bilirubin >2x upper limit of normal (unless participant has Gilbert syndrome)
• Creatinine Clearance or eGFR <60 ml/minute (adjusted for race)
• Hemoglobin < 10 g/dL
• Absolute neutrophil count < 1000/microliter
• Platelet count <130,000/mm3 (if platelet clumping is present on hematology slide review, platelet count <100,000/mm3 is considered exclusionary to study)
• Hemoglobin A1c >= 6%
• Thyroid-stimulating hormone (TSH) and adrenocorticotropic hormone (ACTH) within normal limits. If TSH is not within normal limits then the participant may be eligible if thyroxine (T4) is within normal limits. Participants are not excluded if they are on a stable dose of replacement thyroid medication; dose may be adjusted as needed.
• Previously documented anaphylaxis or severe systemic reaction to check point inhibitors, acetaminophen, or diphenhydramine.
• A severe psychiatric condition, which based on the assessment of the study investigators, will impact the ability to complete the study.
• Pregnancy or planning to get pregnant.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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