Long COVIDPhase 2NCT06821087
Evaluating the Neuromodulatory Effect of Ketamine in Long COVID-19
A Phase 2 study testing Ketamine only in people with Long COVID, run by University of Texas at Austin at 1 site in United States.
Trial summary
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"). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Ketamine only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 22 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- All participants must be eligible for MRI and will undergo MRI scans pre- and post-treatment
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Neuromodulatory Effect of Ketamine in Long COVID: A Pilot Study Targeting Fatigue and Neurocognitive Symptoms
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.
Read more
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. All 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, 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.
- Conditions
- Long COVID
- Being tested
- Ketamine only
- Keywords
- Long COVID, Post-COVID Condition, Post-Acute Sequelae of COVID-19, Brain Fog, Fatigue, Ketamine
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mental Fatigue, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine onlyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Therapy | Experimental | 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. Participants will receive fMRI imaging pre- and post-treatment. Receives: Drug: Ketamine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS SF v1.0 - Fatigue 8a
A patient-reported questionnaire measuring the severity and impact of fatigue on daily activities over the past 7 days. Higher scores indicate greater fatigue.
Measured: At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment.
PROMIS SF v2.0 Cognitive Function 4a
A patient-reported tool that measures perceived cognitive abilities, such as memory, concentration, and mental clarity, over the past 7 days. Higher scores reflect better cognitive function.
Measured: At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment.
Secondary outcomes (10)
PROMIS Global 10 v1.2
A 10-item questionnaire assessing overall physical, mental, and social health, including pain, fatigue, and emotional well-being.
Measured: Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session).
NASA Task Load Index (NASA-TLX)
A tool used to evaluate perceived mental workload, assessing factors like mental demand, effort, and frustration during cognitive tasks like BrainCheck.
Measured: Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session).
Patient Health Questionnaire-9 (PHQ-9)
A widely used self-report measure to assess the severity of depressive symptoms over the past two weeks.
Measured: Collected before each ketamine treatment session, at baseline, and at the post-treatment assessment (6 weeks post-treatment).
Number of participants with treatment-related adverse events as assessed by standardized interview
A standardized interview conducted post-treatment to identify and record any physical or psychological side effects experienced by participants during the ketamine therapy.
Measured: Adverse events will be assessed at each of the four ketamine treatment sessions and during the final post-treatment assessment, which occurs six weeks after the last ketamine injection.
BrainCheck Cognitive Battery
A computerized series of neuropsychological tests assessing objective cognitive functions, including memory, attention, executive function, processing speed, and response inhibition. Scores are age-normalized.
Measured: At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment.
Generalized Anxiety Disorder-7 (GAD-7)
A widely used 7-item scale measuring the severity of anxiety symptoms over the past two weeks.
Measured: Collected before each ketamine treatment session, at baseline, and at the post-treatment assessment (6 weeks post-treatment).
Depression in Medically Ill 10 Scale (DMI-10)
A measure designed to assess depressive symptoms specifically in individuals with medical conditions, focusing on somatic and cognitive symptoms.
Measured: Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session).
Long COVID Review of Systems
A comprehensive symptom checklist adapted from the WHO's Global COVID-19 Clinical Platform, evaluating the range and severity of Long COVID symptoms.
Measured: Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session).
Neuroimaging (MRI) Outcomes
Functional MRI (fMRI) scans will evaluate changes in brain structure and connectivity, providing insight into the neurological effects and mechanisms of ketamine.
Measured: Performed at baseline and repeated at the post-treatment assessment (6 weeks after the final ketamine session).
Serum Biomarker Analysis
Blood samples will be analyzed for inflammatory and metabolic markers, including cytokines and metabolites in the kynurenine pathway, to assess biological responses to ketamine treatment.
Measured: Collected at baseline and at the post-treatment assessment (6 weeks after the final ketamine session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start5 Jun 2025
- Primary completion22 Jun 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Roots Behavioral Health
- Responsible party
- Principal investigator, William Michael Brode, University of Texas at Austin
- Investigators
- W. Michael Brode, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821087
- Sponsor's protocol ID
- STUDY00006367
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) to be shared will include de-identified data related to primary and secondary outcomes, such as patient-reported outcomes (e.g., PROMIS Fatigue and Cognitive Function scores), objective cognitive assessments from the BrainCheck battery, and adverse event reports. Additionally, de-identified neuroimaging data (for participants undergoing MRI) and biomarker data from blood samples will be included. Only data used in the results publication and relevant to the study's primary and secondary outcomes will be shared. All shared data will be stripped of personal identifiers to maintain participant confidentiality, following HIPAA guidelines.
Publications
Chakraborty C, Bhattacharya M. The current landscape of long COVID clinical trials: NIH's RECOVER to Stanford Medicine's STOP-PASC initiative. Mol Ther Nucleic Acids. 2023 Aug 28;33:887-889. doi: 10.1016/j.omtn.2023.08.016. eCollection 2023 Sep 12. No abstract available.
PubMed 37680987Herrera JE, Niehaus WN, Whiteson J, Azola A, Baratta JM, Fleming TK, Kim SY, Naqvi H, Sampsel S, Silver JK, Verduzco-Gutierrez M, Maley J, Herman E, Abramoff B. Multidisciplinary collaborative consensus guidance statement on the assessment and treatment of fatigue in postacute sequelae of SARS-CoV-2 infection (PASC) patients. PM R. 2021 Sep;13(9):1027-1043. doi: 10.1002/pmrj.12684. Epub 2021 Aug 24. No abstract available.
PubMed 34346558Cheng AL, Anderson J, Didehbani N, Fine JS, Fleming TK, Karnik R, Longo M, Ng R, Re'em Y, Sampsel S, Shulman J, Silver JK, Twaite J, Verduzco-Gutierrez M, Kurylo M. Multi-disciplinary collaborative consensus guidance statement on the assessment and treatment of mental health symptoms in patients with post-acute sequelae of SARS-CoV-2 infection (PASC). PM R. 2023 Dec;15(12):1588-1604. doi: 10.1002/pmrj.13085. Epub 2023 Nov 8. No abstract available.
PubMed 37937672Blitshteyn S, Whiteson JH, Abramoff B, Azola A, Bartels MN, Bhavaraju-Sanka R, Chung T, Fleming TK, Henning E, Miglis MG, Sampsel S, Silver JK, Tosto J, Verduzco-Gutierrez M, Putrino D. Multi-disciplinary collaborative consensus guidance statement on the assessment and treatment of autonomic dysfunction in patients with post-acute sequelae of SARS-CoV-2 infection (PASC). PM R. 2022 Oct;14(10):1270-1291. doi: 10.1002/pmrj.12894. Epub 2022 Oct 8. No abstract available.
PubMed 36169154Melamed E, Rydberg L, Ambrose AF, Bhavaraju-Sanka R, Fine JS, Fleming TK, Herman E, Phipps Johnson JL, Kucera JR, Longo M, Niehaus W, Oleson CV, Sampsel S, Silver JK, Smith MM, Verduzco-Gutierrez M. Multidisciplinary collaborative consensus guidance statement on the assessment and treatment of neurologic sequelae in patients with post-acute sequelae of SARS-CoV-2 infection (PASC). PM R. 2023 May;15(5):640-662. doi: 10.1002/pmrj.12976. Epub 2023 May 9. No abstract available.
PubMed 36989078Global COVID-19 Clinical Platform Case Report Form (CRF) for Post COVID condition (Post COVID-19 CRF). Accessed June 11, 2023. https://www.who.int/publications-detail-redirect/global-covid-19-clinical-platform-case-report-form-(crf)-for-post-covid-conditions-(post-covid-19-crf-)
Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351.
PubMed 3496763Valdes Hernandez Mdel C, Armitage PA, Thrippleton MJ, Chappell F, Sandeman E, Munoz Maniega S, Shuler K, Wardlaw JM. Rationale, design and methodology of the image analysis protocol for studies of patients with cerebral small vessel disease and mild stroke. Brain Behav. 2015 Nov 26;5(12):e00415. doi: 10.1002/brb3.415. eCollection 2015 Dec.
PubMed 26807340Groppell S, Soto-Ruiz KM, Flores B, Dawkins W, Smith I, Eagleman DM, Katz Y. A Rapid, Mobile Neurocognitive Screening Test to Aid in Identifying Cognitive Impairment and Dementia (BrainCheck): Cohort Study. JMIR Aging. 2019 Mar 21;2(1):e12615. doi: 10.2196/12615.
PubMed 31518280Marcantoni WS, Akoumba BS, Wassef M, Mayrand J, Lai H, Richard-Devantoy S, Beauchamp S. A systematic review and meta-analysis of the efficacy of intravenous ketamine infusion for treatment resistant depression: January 2009 - January 2019. J Affect Disord. 2020 Dec 1;277:831-841. doi: 10.1016/j.jad.2020.09.007. Epub 2020 Sep 7.
PubMed 33065824Nikolin S, Rodgers A, Schwaab A, Bahji A, Zarate C Jr, Vazquez G, Loo C. Ketamine for the treatment of major depression: a systematic review and meta-analysis. EClinicalMedicine. 2023 Aug 3;62:102127. doi: 10.1016/j.eclinm.2023.102127. eCollection 2023 Aug.
PubMed 37593223Lenze EJ, Reiersen AM, Zorumski CF, Santosh PJ. Beyond "Psychotropic": Repurposing Psychiatric Drugs for COVID-19, Alzheimer's Disease, and Cancer. J Clin Psychiatry. 2023 Mar 20;84(3):22r14494. doi: 10.4088/JCP.22r14494.
PubMed 36946597Nikolich JZ, Rosen CJ. Toward Comprehensive Care for Long Covid. N Engl J Med. 2023 Jun 8;388(23):2113-2115. doi: 10.1056/NEJMp2304550. Epub 2023 May 9. No abstract available.
PubMed 37158440Walsh Z, Mollaahmetoglu OM, Rootman J, Golsof S, Keeler J, Marsh B, Nutt DJ, Morgan CJA. Ketamine for the treatment of mental health and substance use disorders: comprehensive systematic review. BJPsych Open. 2021 Dec 23;8(1):e19. doi: 10.1192/bjo.2021.1061.
PubMed 35048815McIntyre RS, Rosenblat JD, Nemeroff CB, Sanacora G, Murrough JW, Berk M, Brietzke E, Dodd S, Gorwood P, Ho R, Iosifescu DV, Lopez Jaramillo C, Kasper S, Kratiuk K, Lee JG, Lee Y, Lui LMW, Mansur RB, Papakostas GI, Subramaniapillai M, Thase M, Vieta E, Young AH, Zarate CA Jr, Stahl S. Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation. Am J Psychiatry. 2021 May 1;178(5):383-399. doi: 10.1176/appi.ajp.2020.20081251. Epub 2021 Mar 17.
PubMed 33726522
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Neuromodulatory Effect of Ketamine in Long COVID: A Pilot Study Targeting Fatigue and Neurocognitive Symptoms
- ClinicalTrials.gov ID
- NCT06821087
- Acronym / sponsor ID
- STUDY00006367
- Conditions
- Long COVID
- Keywords
- Long COVID, Post-COVID Condition, Post-Acute Sequelae of COVID-19, Brain Fog, Fatigue, Ketamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Roots Behavioral Health
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. All 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine Therapy | Experimental | Drug: Ketamine onlyParticipants 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. Participants will receive fMRI imaging pre- and post-treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- All participants must be eligible for MRI and will undergo MRI scans pre- and post-treatment
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine onlyParticipants 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. | Drug | Ketamine Therapy |
Primary outcome
PROMIS SF v1.0 - Fatigue 8a
Time frame: At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment.
A patient-reported questionnaire measuring the severity and impact of fatigue on daily activities over the past 7 days. Higher scores indicate greater fatigue.
PROMIS SF v2.0 Cognitive Function 4a
Time frame: At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment.
A patient-reported tool that measures perceived cognitive abilities, such as memory, concentration, and mental clarity, over the past 7 days. Higher scores reflect better cognitive function.
10 secondary outcomes
PROMIS Global 10 v1.2
Time frame: Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session).
NASA Task Load Index (NASA-TLX)
Time frame: Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session).
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Collected before each ketamine treatment session, at baseline, and at the post-treatment assessment (6 weeks post-treatment).
Number of participants with treatment-related adverse events as assessed by standardized interview
Time frame: Adverse events will be assessed at each of the four ketamine treatment sessions and during the final post-treatment assessment, which occurs six weeks after the last ketamine injection.
BrainCheck Cognitive Battery
Time frame: At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Collected before each ketamine treatment session, at baseline, and at the post-treatment assessment (6 weeks post-treatment).
Depression in Medically Ill 10 Scale (DMI-10)
Time frame: Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session).
Long COVID Review of Systems
Time frame: Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session).
Neuroimaging (MRI) Outcomes
Time frame: Performed at baseline and repeated at the post-treatment assessment (6 weeks after the final ketamine session).
Serum Biomarker Analysis
Time frame: Collected at baseline and at the post-treatment assessment (6 weeks after the final ketamine session).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 37680987Chakraborty C, Bhattacharya M. The current landscape of long COVID clinical trials: NIH's RECOVER to Stanford Medicine's STOP-PASC initiative. Mol Ther Nucleic Acids. 2023 Aug 28;33:887-889. doi: 10.1016/j.omtn.2023.08.016. eCollection 2023 Sep 12. No abstract available.
- Background: PubMed 34346558Herrera JE, Niehaus WN, Whiteson J, Azola A, Baratta JM, Fleming TK, Kim SY, Naqvi H, Sampsel S, Silver JK, Verduzco-Gutierrez M, Maley J, Herman E, Abramoff B. Multidisciplinary collaborative consensus guidance statement on the assessment and treatment of fatigue in postacute sequelae of SARS-CoV-2 infection (PASC) patients. PM R. 2021 Sep;13(9):1027-1043. doi: 10.1002/pmrj.12684. Epub 2021 Aug 24. No abstract available.
- Background: PubMed 37937672Cheng AL, Anderson J, Didehbani N, Fine JS, Fleming TK, Karnik R, Longo M, Ng R, Re'em Y, Sampsel S, Shulman J, Silver JK, Twaite J, Verduzco-Gutierrez M, Kurylo M. Multi-disciplinary collaborative consensus guidance statement on the assessment and treatment of mental health symptoms in patients with post-acute sequelae of SARS-CoV-2 infection (PASC). PM R. 2023 Dec;15(12):1588-1604. doi: 10.1002/pmrj.13085. Epub 2023 Nov 8. No abstract available.
- Background: PubMed 36169154Blitshteyn S, Whiteson JH, Abramoff B, Azola A, Bartels MN, Bhavaraju-Sanka R, Chung T, Fleming TK, Henning E, Miglis MG, Sampsel S, Silver JK, Tosto J, Verduzco-Gutierrez M, Putrino D. Multi-disciplinary collaborative consensus guidance statement on the assessment and treatment of autonomic dysfunction in patients with post-acute sequelae of SARS-CoV-2 infection (PASC). PM R. 2022 Oct;14(10):1270-1291. doi: 10.1002/pmrj.12894. Epub 2022 Oct 8. No abstract available.
- Background: PubMed 36989078Melamed E, Rydberg L, Ambrose AF, Bhavaraju-Sanka R, Fine JS, Fleming TK, Herman E, Phipps Johnson JL, Kucera JR, Longo M, Niehaus W, Oleson CV, Sampsel S, Silver JK, Smith MM, Verduzco-Gutierrez M. Multidisciplinary collaborative consensus guidance statement on the assessment and treatment of neurologic sequelae in patients with post-acute sequelae of SARS-CoV-2 infection (PASC). PM R. 2023 May;15(5):640-662. doi: 10.1002/pmrj.12976. Epub 2023 May 9. No abstract available.
- BackgroundGlobal COVID-19 Clinical Platform Case Report Form (CRF) for Post COVID condition (Post COVID-19 CRF). Accessed June 11, 2023. https://www.who.int/publications-detail-redirect/global-covid-19-clinical-platform-case-report-form-(crf)-for-post-covid-conditions-(post-covid-19-crf-)
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- Background: PubMed 31518280Groppell S, Soto-Ruiz KM, Flores B, Dawkins W, Smith I, Eagleman DM, Katz Y. A Rapid, Mobile Neurocognitive Screening Test to Aid in Identifying Cognitive Impairment and Dementia (BrainCheck): Cohort Study. JMIR Aging. 2019 Mar 21;2(1):e12615. doi: 10.2196/12615.
- Background: PubMed 33065824Marcantoni WS, Akoumba BS, Wassef M, Mayrand J, Lai H, Richard-Devantoy S, Beauchamp S. A systematic review and meta-analysis of the efficacy of intravenous ketamine infusion for treatment resistant depression: January 2009 - January 2019. J Affect Disord. 2020 Dec 1;277:831-841. doi: 10.1016/j.jad.2020.09.007. Epub 2020 Sep 7.
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- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) to be shared will include de-identified data related to primary and secondary outcomes, such as patient-reported outcomes (e.g., PROMIS Fatigue and Cognitive Function scores), objective cognitive assessments from the BrainCheck battery, and adverse event reports. Additionally, de-identified neuroimaging data (for participants undergoing MRI) and biomarker data from blood samples will be included. Only data used in the results publication and relevant to the study's primary and secondary outcomes will be shared. All shared data will be stripped of personal identifiers to maintain participant confidentiality, following HIPAA guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Michael Brode, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine only in people with Long COVID, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS SF v1.0 - Fatigue 8a (time frame: At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821087, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.