Cancer drug keytruda tested as possible treatment for long COVID brain fog
NCT ID NCT07388550
First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 60 times
Summary
This early-stage trial tests whether a single dose of pembrolizumab (Keytruda), a drug used for cancer, can safely reduce long-term neurological symptoms like brain fog and dizziness in people with long COVID. Fifteen adults who had COVID-19 at least six months ago and still have nerve-related symptoms will receive one IV dose and be followed for six months. The main goal is to check safety, but researchers will also look for signs of improvement in thinking, movement, and daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab (Keytruda)
- What this could lead to
- If it works, this could point toward a treatment for brain fog, dizziness, and other lasting neurological symptoms after COVID-19.
- What could go wrong
- This is a very early, small Phase 1 safety trial with only 15 people, so it is not designed to prove the drug works. Pembrolizumab can cause immune-related side effects, and its safety for long COVID is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 110 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female, aged at least 18 or older. --Documentation of the SARS-CoV-2 infection that led to development of PASC confirmed either by a positive testing by a commercial laboratory or a positive home test followed by confirmatory nucleocapsid antibody testing. * Previously diagnosed with mild-moderate COVID-19 (WHO Clinical Progression Scale between 2-5. Participants who had severe acute COVID-19 requiring hospitalization or ICU care are excluded. * If participants had multiple SARS-CoV-2 infections, they would need to be at least 6 months after the last infection. * All participants would need to have a negative SARS-CoV-2 nasal swab at the time of enrollment. * Exhibiting persistent neurologic symptoms evidenced by a self-reported illness narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 infection. These include symptoms such as fatigue, cognitive difficulties, sleep disturbances, orthostatic intolerance, and any ongoing issues with gait instability, vision, speech, swallowing, sensation, or strength. Symptoms must persist for at least 6 months after the diagnosis of acute COVID-19. * All participants will have PD-1 expression on CD8 T cells that is one SD above the mean value of normal controls as established in the SINS Lab and published previously. * Moderate to severe PASC symptom severity, as determined using PCFS (minimal score of 3). * Ability of participant to understand and sign a written informed consent document. * Prior completion of a clinical brain MRI after the diagnosis of COVID-19, or willingness to complete a brain MRI. * Agrees not to have vaccinations over the course of the study. * Participants of childbearing potential must agree to use a combination of contraception (defined as two forms of effective birth control) 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: 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. * Currently lactating/breastfeeding. * Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed. * Current or past substance use disorder within last five years. Marijuana use within the past five years will not be an exclusion. * Infection with HIV, tuberculosis, hepatitis B or C.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Post-acute COVID-19 syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an arthritis drug clear long COVID brain fog?
- Mindfulness may offer relief for long COVID sufferers
- Five years on: how does long COVID evolve?
- Spirulina extract put to the test against long COVID inflammation
- Can brain training zap long COVID brain fog?
- Can tailored exercise help tame racing heart and fatigue after COVID?