Plain Language Summary:This study is a clinical trial to see if ketamine can help treat symptoms of Long COVID,especially fatigue and problems with thinking clearly (often called "brain fog"). LongCOVID is a condition that affects people even after they have recovered from COVID-19,causing ongoing health issues like tiredness, memory problems, and difficultyconcentrating. Right now, there are very few treatments available for these symptoms, andmany people are looking for new options to feel better.What is the study trying to find out? Does ketamine help reduce fatigue and improvethinking skills in people with Long COVID? Does ketamine improve overall quality of lifeand mental health for people with Long COVID? Is ketamine safe and well-tolerated forpeople with Long COVID? How does ketamine affect the body's biological processes, likeinflammation and brain function? How will the study work?The study will include 20 adults between 18 and 65 years old who have Long COVID symptomslike fatigue or brain fog.Participants will first meet with researchers to answer health questions, take surveysabout their symptoms, and do tests to check their thinking skills. Some participants willalso have a brain scan (MRI) and give a blood sample to look at markers of inflammation.Participants will then receive four ketamine treatments over two weeks at a specializedclinic. The ketamine will be given as an injection, with the dose slightly increasingduring the treatment period.After six weeks, participants will return for follow-up tests to see if their symptomshave improved. This includes repeating the surveys, thinking tests, and for some, anotherMRI and blood test.Why ketamine? Ketamine is a medicine originally used for anesthesia but has also beenfound to help with depression and other mental health issues. Researchers think it mighthelp with Long COVID symptoms because it can reduce inflammation in the brain and improvehow the brain functions. People with Long COVID often have signs of inflammation andchanges in brain chemicals, which ketamine might help balance.What are the potential benefits? Participants might experience less fatigue and clearerthinking after ketamine treatment. They could also feel better overall in terms of moodand quality of life. Since ketamine can work quickly, some people may notice improvementsshortly after starting the treatment.What are the risks? Ketamine can cause side effects like feeling dizzy, anxious, orhaving an unusual sense of reality (sometimes called dissociation). It may also causetemporary increases in blood pressure or heart rate. All treatments will be carefullymonitored by healthcare professionals to ensure safety.Who can participate? Adults aged 18-65 with Long COVID who have significant fatigue orthinking problems can join. People will not be able to participate if they have certainhealth conditions like severe heart disease, uncontrolled high blood pressure, or ahistory of severe mental health disorders.Why is this study important? Long COVID affects millions of people, and many arestruggling to find treatments that work. This study is one of the first to exploreketamine as a potential treatment for Long COVID symptoms. If ketamine helps, it couldlead to more research and eventually new treatment options for people living with LongCOVID.
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Drug: Ketamine only
Participants in this arm will receive four intramuscular (IM) ketamine injections over a
two-week period. The initial dose will be 0.5 mg/kg during the first session, increasing
to 0.65 mg/kg in the second session, and 0.75 mg/kg for the third and fourth sessions.
Injections will be administered at least three days apart.
Inclusion Criteria:
- Adults aged 18-65 years diagnosed with LC and possess a documented history of
positive COVID-19 diagnostic testing or a probable infection as determined by a
healthcare provider.
- One persistent symptom of fatigue or neurocognitive dysfunction as defined by rating
their symptoms as moderate to severe on the screening form.
- English as a primary language OR comprehension of English suitable to understand
research staff instructions.
The first 5 male and first 5 female participants to enroll will be invited to participate
in the MRI portion of the study, provided they have no contraindications to MRI on
screening. If participants decline to participate in the MRI portion, it will be offered
to subsequent participants upon enrollment, ensuring there is no gender imbalance greater
than 6 to 4 for the MRI portion.
Exclusion Criteria:
Contraindications to ketamine therapy:
- Current substance use disorder
- Current mania or psychosis
- Recent myocardial infarction or stroke (within 1 year)
- Unstable cardiovascular disease (including uncontrolled high blood pressure >
180/110 mmHg)
- Uncontrolled seizure disorder
- Pregnancy
Additional exclusion criteria include:
- Recent COVID-19 infection or reinfection within 8 weeks
- Prior receipt of ketamine treatment
- History of treatment resistant depression (TRD) prior to development of LC
- Defined as completing a trial (2 months of treatment at highest tolerated dose)
of 3 or more psychotropic medications from at least 2 classes of medications
(i.e. SSRIs, SNRIs, antipsychotic medications, or mood stabilizers such as
lithium, lamotrigine, Depakote, or oxcarbazepine)
- Psychotropic medications used during treatment of LC will not be counted as
medications used for TRD
- Current severe depression or anxiety, and/or active suicidal ideation
- Severe depression and anxiety defined as scoring > 19 on PHQ-9 screening or >
14 on GAD-7 screening.
- Active suicidal ideation is defined as answering "yes" to question #9 on the
PHQ-9
- History of bipolar disorder, schizophrenia, or schizoaffective disorder
- History of suicide attempt or psychiatric hospitalization for any reason in the last
5 years
- Current benzodiazepine or naltrexone medication use within 4 weeks of enrollment as
these may decrease or block the therapeutic effect of ketamine treatment
Note participants with contraindications to MRI imaging will be excluded from the subset
of 10 patients undergoing that testing
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Kristina Kashyap
512-270-0614
kristina.kashyap@austin.utexas.edu
W. Michael Brode, MD, Principal Investigator
University of Texas at Austin