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Purpose

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"). Long COVID is a condition that affects people even after they have recovered from COVID-19, causing ongoing health issues like tiredness, memory problems, and difficulty concentrating. Right now, there are very few treatments available for these symptoms, and many people are looking for new options to feel better. What is the study trying to find out? Does ketamine help reduce fatigue and improve thinking skills in people with Long COVID? Does ketamine improve overall quality of life and mental health for people with Long COVID? Is ketamine safe and well-tolerated for people with Long COVID? How does ketamine affect the body's biological processes, like inflammation and brain function? How will the study work? The study will include 20 adults between 18 and 65 years old who have Long COVID symptoms like fatigue or brain fog. Participants will first meet with researchers to answer health questions, take surveys about their symptoms, and do tests to check their thinking skills. Some participants will also 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 specialized clinic. The ketamine will be given as an injection, with the dose slightly increasing during the treatment period. After six weeks, participants will return for follow-up tests to see if their symptoms have improved. This includes repeating the surveys, thinking tests, and for some, another MRI and blood test. Why ketamine? Ketamine is a medicine originally used for anesthesia but has also been found to help with depression and other mental health issues. Researchers think it might help with Long COVID symptoms because it can reduce inflammation in the brain and improve how the brain functions. People with Long COVID often have signs of inflammation and changes in brain chemicals, which ketamine might help balance. What are the potential benefits? Participants might experience less fatigue and clearer thinking after ketamine treatment. They could also feel better overall in terms of mood and quality of life. Since ketamine can work quickly, some people may notice improvements shortly after starting the treatment. What are the risks? Ketamine can cause side effects like feeling dizzy, anxious, or having an unusual sense of reality (sometimes called dissociation). It may also cause temporary increases in blood pressure or heart rate. All treatments will be carefully monitored by healthcare professionals to ensure safety. Who can participate? Adults aged 18-65 with Long COVID who have significant fatigue or thinking problems can join. People will not be able to participate if they have certain health conditions like severe heart disease, uncontrolled high blood pressure, or a history of severe mental health disorders. Why is this study important? Long COVID affects millions of people, and many are struggling to find treatments that work. This study is one of the first to explore ketamine as a potential treatment for Long COVID symptoms. If ketamine helps, it could lead to more research and eventually new treatment options for people living with Long COVID.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ketamine Therapy 		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. All treatments will be conducted under medical supervision at a specialized clinic with standard safety protocols in place. Vital signs will be monitored before, during, and after each session to assess tolerability. Participants will also undergo assessments of fatigue, cognitive function, quality of life, and biomarkers pre- and post-treatment. A subset of 10 participants will receive fMRI imaging pre- and post-treatment.
  • 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.

Recruiting Locations

More Details

NCT ID
NCT06821087
Status
Enrolling by invitation
Sponsor
University of Texas at Austin

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.