Evaluating the Neuromodulatory Effect of Ketamine in Long COVID-19

Launched by UNIVERSITY OF TEXAS AT AUSTIN · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is researching whether ketamine, a medication originally used for anesthesia, can help improve symptoms of Long COVID, such as fatigue and “brain fog” (difficulty thinking clearly). Long COVID can affect people even after they have recovered from COVID-19, leading to ongoing issues like tiredness and memory problems. The study will involve 20 adults aged 18 to 65 who have these symptoms. Participants will first complete health questionnaires and tests to assess their thinking skills. Then, they will receive four ketamine treatments over two weeks. After six weeks, they will return for follow-up tests to see if their symptoms have improved.

To join the study, participants must be diagnosed with Long COVID and experiencing significant fatigue or thinking difficulties. However, certain health conditions, like severe heart disease or uncontrolled high blood pressure, may prevent someone from participating. Throughout the trial, healthcare professionals will closely monitor participants to ensure their safety, as ketamine can cause side effects like dizziness or increased heart rate. This research is important because it aims to explore a potential new treatment for Long COVID, which affects millions of people and currently has limited options for relief.

Gender

ALL

Eligibility criteria

• 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