Treatment of Fatigue After Resolution of COVID-19 InfectionAEONCT04592354
Anhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors
A study testing Oxaloacetate Medical Food/Dietary Supplement in people with Treatment of Fatigue After Resolution of COVID-19 Infection, run by Terra Biological LLC at 1 site in United States.
Trial summary
We will conduct a double arm, randomized, double-blinded placebo controlled trial of oxaloacetate for treatment of fatigue in women with a history of COVID-19 infection, resolution of the infection, and remaining fatigue that interfere with everyday activities, based on use of a standardized questionnaire to screen… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Treatment of Fatigue After Resolution of COVID-19 Infection
- What is being tested?
- Oxaloacetate Medical Food/Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 15 Jun 2021
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4.1.1 Women with an initial infection diagnosis COVID-19 that has been resolved, as measured by rRT PCR, who are at least 2 months after proven viral resolution.
- 4.1.2 No evidence of active/recurrent COVID-19 or other serious chronic illness.
- 4.1.3 Have significant fatigue complaints, defined as a bimodal score of 4 or greater on the Fatigue Questionnaire.
- 4.1.4 Is geographically accessible, or can fill out forms virtually, and able to participate in a study of 6-10 weeks duration.
- 4.1.5 Age >18 years and less than 65.
- 4.1.6 Ability to complete evaluation surveys in English.
Show all 11Show fewer
- 4.1.7 The effects of oxaloacetate on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (barrier method of birth control; IUD; abstinence) prior to study entry and for the duration of study participation. Women of any age who have had their ovaries and/or uterus removed will not be at risk for pregnancy and will not require contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
- Menopausal status will be established as follows: Women who are 55 years or older and who are not menstruating will be considered postmenopausal and not at risk for pregnancy. Women who are less than 55 years old who are menstruating will be considered premenopausal and will require contraception. Women who are less than 55 years with an intact uterus and ovaries who are not menstruating and have not had a menstrual period within the past 2 years will have an FSH and estradiol measured. If the values are in postmenopausal range the woman will be considered postmenopausal and she will not be considered at risk for pregnancy.
- 4.1.8 Ability to understand and the willingness to sign a written informed consent document.
- 4.1.9 No diagnosis of Clinical Depression
- 4.1.10 Is not taking an oxaloacetate supplement.
Who cannot join
- 4.2.1 Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in the planned study.
- 4.2.2 Taking chronic medications that would interfere with cognitive functioning such as medications for sleep, anxiety, narcotics for pain, use of illicit medical foods or cannabis.
- 4.2.3 Participants may not be receiving any other investigational agents.
- 4.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaloacetate.
- 4.2.5 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of Covid-19 or other virus, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- 4.2.6 Pregnant or breast-feeding women are excluded from this study because the safety of oxaloacetate in this setting is unknown. A pregnancy test will be performed on all women with an intact uterus and ovaries who are not determined to be postmenopausal, as described in section 4.1.7.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Energy Medicine research Institute
Boulder, Colorado, 80304
Lisa Tully, Ph.D., 303-440-3649, lisa@energymedicineri.com
About this study
We will conduct a double arm, randomized, double-blinded placebo controlled trial of oxaloacetate for treatment of fatigue in women with a history of COVID-19 infection, resolution of the infection, and remaining fatigue that interfere with everyday activities, based on use of a standardized questionnaire to screen for impairment.
Participants will receive a 6-week supply of the active or placebo and will be asked to take one capsule twice a day with water and food. They will be contacted weekly for two weeks by the study coordinator to assess for any side effects or difficulty taking the medication. They will be asked to again to complete the standardized questionnaire to screen for impairment after 2 weeks, and again at the end of the study at 6 weeks. Finally, any adverse reactions and symptoms will be evaluated once again four weeks later to ensure that any symptoms that may have been present during treatment have resolved.
Read the detailed description
We will conduct a double arm, randomized, double-blinded placebo controlled trial of oxaloacetate for treatment of fatigue in women with a history of COVID-19 infection, resolution of the infection, and remaining fatigue that interfere with everyday activities, based on use of a standardized questionnaire to screen for impairment. Women will be recruited from a variety of settings including clinics affiliated with our existing doctor base, outreach through social media and notification of community organizations that serve this patient population. The study will take place at the residences of the participants, being performed virtually after receipt of informed consent paperwork, COVID-19 positive test data, and COVID -19 negative resolution data by us, and by receipt of the test product by the participant. Efforts will be made to conduct as much of this trial virtually as possible due to the Covid-19 pandemic. Women who could potentially be pregnant will undergo pregnancy testing and determination of menopausal status, if appropriate. Participants will complete baseline questionnaires that assess fatigue and depressive symptoms.
Subsequently, the participants will receive a 6-week supply of the active or placebo and will be asked to take one capsule twice a day with water and food. They will be contacted weekly for two weeks by the study coordinator to assess for any side effects or difficulty taking the medication. They will be asked to again to complete the standardized questionnaire to screen for impairment after 2 weeks, and again at the end of the study at 6 weeks. Finally, any adverse reactions and symptoms will be evaluated once again four weeks later to ensure that any symptoms that may have been present during treatment have resolved.
- Being tested
- Oxaloacetate Medical Food/Dietary Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaloacetate Medical Food/Dietary SupplementDietary supplement
500 mg Anhydrous Enol-Oxaloacetate BID
| Study group | Role | What they receive |
|---|---|---|
| Oxaloacetate Therapeutic Arm | Active comparator | * Anhydrous Enol-Oxaloacetate
* A 500 mg oxaloacetate capsule taken by mouth twice a day
* Planned study duration is 6 weeks with an interim assessment at the end of 2 weeks and final assessment at 6 weeks Receives: Dietary Supplement: Oxaloacetate Medical Food/Dietary Supplement |
| Placebo Arm | Placebo comparator | * Rice Flour
* A 500 mg rice flour capsule taken by mouth twice a day Receives: Dietary Supplement: Oxaloacetate Medical Food/Dietary Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Evaluation of self-reported Fatigue with the Fatigue Questionnaire (FQ)
Measured: 6 weeks
Secondary outcomes (2)
Fatigue
Evaluation of self-reported Fatigue with the Fatigue Severity Scale (FSS)
Measured: 6 weeks
Depression
Evaluation of self-reported depression with Beck's Depression Inventory (BDI)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Oct 2020
- Primary completion15 Apr 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Treatment of Fatigue After Resolution of COVID-19 InfectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blinded placebo controlled comparison study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terra Biological LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Tully, Ph.D., Principal investigator, Energy Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592354
- Sponsor's protocol ID
- TB-AEO-2020 Post Covid Fatigue
- Acronym
- AEO
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to publish the data so that it is available to other researchers.
Publications
Rasa S, Nora-Krukle Z, Henning N, Eliassen E, Shikova E, Harrer T, Scheibenbogen C, Murovska M, Prusty BK; European Network on ME/CFS (EUROMENE). Chronic viral infections in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). J Transl Med. 2018 Oct 1;16(1):268. doi: 10.1186/s12967-018-1644-y.
PubMed 30285773Lyons D, Frampton M, Naqvi S, Donohoe D, Adams G, Glynn K. Fallout from the COVID-19 pandemic - should we prepare for a tsunami of post viral depression? Ir J Psychol Med. 2020 Dec;37(4):295-300. doi: 10.1017/ipm.2020.40. Epub 2020 May 15.
PubMed 32408926Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2020 Sep 1;3(9):e2019686. doi: 10.1001/jamanetworkopen.2020.19686.
PubMed 32876685Yamamoto HA, Mohanan PV. Effect of alpha-ketoglutarate and oxaloacetate on brain mitochondrial DNA damage and seizures induced by kainic acid in mice. Toxicol Lett. 2003 Jul 20;143(2):115-22. doi: 10.1016/s0378-4274(03)00114-0.
PubMed 12749815Campos F, Sobrino T, Ramos-Cabrer P, Castillo J. Oxaloacetate: a novel neuroprotective for acute ischemic stroke. Int J Biochem Cell Biol. 2012 Feb;44(2):262-5. doi: 10.1016/j.biocel.2011.11.003. Epub 2011 Nov 10.
PubMed 22085530Ruban A, Berkutzki T, Cooper I, Mohar B, Teichberg VI. Blood glutamate scavengers prolong the survival of rats and mice with brain-implanted gliomas. Invest New Drugs. 2012 Dec;30(6):2226-35. doi: 10.1007/s10637-012-9799-5.
PubMed 22392507Nagy D, Marosi M, Kis Z, Farkas T, Rakos G, Vecsei L, Teichberg VI, Toldi J. Oxaloacetate decreases the infarct size and attenuates the reduction in evoked responses after photothrombotic focal ischemia in the rat cortex. Cell Mol Neurobiol. 2009 Sep;29(6-7):827-35. doi: 10.1007/s10571-009-9364-8. Epub 2009 Mar 4.
PubMed 19259807Zlotnik A, Gurevich B, Tkachov S, Maoz I, Shapira Y, Teichberg VI. Brain neuroprotection by scavenging blood glutamate. Exp Neurol. 2007 Jan;203(1):213-20. doi: 10.1016/j.expneurol.2006.08.021. Epub 2006 Oct 2.
PubMed 17014847Nagy D, Knapp L, Marosi M, Farkas T, Kis Z, Vecsei L, Teichberg VI, Toldi J. Effects of blood glutamate scavenging on cortical evoked potentials. Cell Mol Neurobiol. 2010 Oct;30(7):1101-6. doi: 10.1007/s10571-010-9542-8. Epub 2010 Jul 6.
PubMed 20607387Swerdlow RH, Bothwell R, Hutfles L, Burns JM, Reed GA. Tolerability and pharmacokinetics of oxaloacetate 100 mg capsules in Alzheimer's subjects. BBA Clin. 2016 Mar 10;5:120-3. doi: 10.1016/j.bbacli.2016.03.005. eCollection 2016 Jun.
PubMed 27051598Vidoni ED, Choi IY, Lee P, Reed G, Zhang N, Pleen J, Mahnken JD, Clutton J, Becker A, Sherry E, Bothwell R, Anderson H, Harris RA, Brooks W, Wilkins HM, Mosconi L, Burns JM, Swerdlow RH. Safety and target engagement profile of two oxaloacetate doses in Alzheimer's patients. Alzheimers Dement. 2021 Jan;17(1):7-17. doi: 10.1002/alz.12156. Epub 2020 Jul 27.
PubMed 32715609Matsos A, Johnston IN. Chemotherapy-induced cognitive impairments: A systematic review of the animal literature. Neurosci Biobehav Rev. 2019 Jul;102:382-399. doi: 10.1016/j.neubiorev.2019.05.001. Epub 2019 May 4.
PubMed 31063740Dantzer R, Kelley KW. Twenty years of research on cytokine-induced sickness behavior. Brain Behav Immun. 2007 Feb;21(2):153-60. doi: 10.1016/j.bbi.2006.09.006. Epub 2006 Nov 7.
PubMed 17088043Haroon E, Miller AH, Sanacora G. Inflammation, Glutamate, and Glia: A Trio of Trouble in Mood Disorders. Neuropsychopharmacology. 2017 Jan;42(1):193-215. doi: 10.1038/npp.2016.199. Epub 2016 Sep 15.
PubMed 27629368
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors
- ClinicalTrials.gov ID
- NCT04592354
- Acronym / sponsor ID
- AEO / TB-AEO-2020 Post Covid Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Terra Biological LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
We will conduct a double arm, randomized, double-blinded placebo controlled trial of oxaloacetate for treatment of fatigue in women with a history of COVID-19 infection, resolution of the infection, and remaining fatigue that interfere with everyday activities, based on use of a standardized questionnaire to screen for impairment.
Participants will receive a 6-week supply of the active or placebo and will be asked to take one capsule twice a day with water and food. They will be contacted weekly for two weeks by the study coordinator to assess for any side effects or difficulty taking the medication. They will be asked to again to complete the standardized questionnaire to screen for impairment after 2 weeks, and again at the end of the study at 6 weeks. Finally, any adverse reactions and symptoms will be evaluated once again four weeks later to ensure that any symptoms that may have been present during treatment have resolved.
Detailed description
We will conduct a double arm, randomized, double-blinded placebo controlled trial of oxaloacetate for treatment of fatigue in women with a history of COVID-19 infection, resolution of the infection, and remaining fatigue that interfere with everyday activities, based on use of a standardized questionnaire to screen for impairment. Women will be recruited from a variety of settings including clinics affiliated with our existing doctor base, outreach through social media and notification of community organizations that serve this patient population. The study will take place at the residences of the participants, being performed virtually after receipt of informed consent paperwork, COVID-19 positive test data, and COVID -19 negative resolution data by us, and by receipt of the test product by the participant. Efforts will be made to conduct as much of this trial virtually as possible due to the Covid-19 pandemic. Women who could potentially be pregnant will undergo pregnancy testing and determination of menopausal status, if appropriate. Participants will complete baseline questionnaires that assess fatigue and depressive symptoms.
Subsequently, the participants will receive a 6-week supply of the active or placebo and will be asked to take one capsule twice a day with water and food. They will be contacted weekly for two weeks by the study coordinator to assess for any side effects or difficulty taking the medication. They will be asked to again to complete the standardized questionnaire to screen for impairment after 2 weeks, and again at the end of the study at 6 weeks. Finally, any adverse reactions and symptoms will be evaluated once again four weeks later to ensure that any symptoms that may have been present during treatment have resolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blinded placebo controlled comparison study
| Arm | Type | Receives |
|---|---|---|
| Oxaloacetate Therapeutic Arm | Active comparator | Dietary Supplement: Oxaloacetate Medical Food/Dietary Supplement* Anhydrous Enol-Oxaloacetate * A 500 mg oxaloacetate capsule taken by mouth twice a day * Planned study duration is 6 weeks with an interim assessment at the end of 2 weeks and final assessment at 6 weeks |
| Placebo Arm | Placebo comparator | Dietary Supplement: Oxaloacetate Medical Food/Dietary Supplement* Rice Flour * A 500 mg rice flour capsule taken by mouth twice a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 4.1.1 Women with an initial infection diagnosis COVID-19 that has been resolved, as measured by rRT PCR, who are at least 2 months after proven viral resolution.
- 4.1.2 No evidence of active/recurrent COVID-19 or other serious chronic illness.
- 4.1.3 Have significant fatigue complaints, defined as a bimodal score of 4 or greater on the Fatigue Questionnaire.
- 4.1.4 Is geographically accessible, or can fill out forms virtually, and able to participate in a study of 6-10 weeks duration.
- 4.1.5 Age >18 years and less than 65.
Key exclusion criteria (6 listed)
- 4.2.1 Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in the planned study.
- 4.2.2 Taking chronic medications that would interfere with cognitive functioning such as medications for sleep, anxiety, narcotics for pain, use of illicit medical foods or cannabis.
- 4.2.3 Participants may not be receiving any other investigational agents.
- 4.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaloacetate.
- 4.2.5 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of Covid-19 or other virus, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Oxaloacetate Medical Food/Dietary Supplement500 mg Anhydrous Enol-Oxaloacetate BID | Dietary supplement | Oxaloacetate Therapeutic Arm, Placebo Arm |
Primary outcome
Fatigue
Time frame: 6 weeks
Evaluation of self-reported Fatigue with the Fatigue Questionnaire (FQ)
2 secondary outcomes
Fatigue
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 30285773Rasa S, Nora-Krukle Z, Henning N, Eliassen E, Shikova E, Harrer T, Scheibenbogen C, Murovska M, Prusty BK; European Network on ME/CFS (EUROMENE). Chronic viral infections in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). J Transl Med. 2018 Oct 1;16(1):268. doi: 10.1186/s12967-018-1644-y.
- Background: PubMed 32408926Lyons D, Frampton M, Naqvi S, Donohoe D, Adams G, Glynn K. Fallout from the COVID-19 pandemic - should we prepare for a tsunami of post viral depression? Ir J Psychol Med. 2020 Dec;37(4):295-300. doi: 10.1017/ipm.2020.40. Epub 2020 May 15.
- Background: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Background: PubMed 32876685Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2020 Sep 1;3(9):e2019686. doi: 10.1001/jamanetworkopen.2020.19686.
- Background: PubMed 12749815Yamamoto HA, Mohanan PV. Effect of alpha-ketoglutarate and oxaloacetate on brain mitochondrial DNA damage and seizures induced by kainic acid in mice. Toxicol Lett. 2003 Jul 20;143(2):115-22. doi: 10.1016/s0378-4274(03)00114-0.
- Background: PubMed 22085530Campos F, Sobrino T, Ramos-Cabrer P, Castillo J. Oxaloacetate: a novel neuroprotective for acute ischemic stroke. Int J Biochem Cell Biol. 2012 Feb;44(2):262-5. doi: 10.1016/j.biocel.2011.11.003. Epub 2011 Nov 10.
- Background: PubMed 22392507Ruban A, Berkutzki T, Cooper I, Mohar B, Teichberg VI. Blood glutamate scavengers prolong the survival of rats and mice with brain-implanted gliomas. Invest New Drugs. 2012 Dec;30(6):2226-35. doi: 10.1007/s10637-012-9799-5.
- Background: PubMed 19259807Nagy D, Marosi M, Kis Z, Farkas T, Rakos G, Vecsei L, Teichberg VI, Toldi J. Oxaloacetate decreases the infarct size and attenuates the reduction in evoked responses after photothrombotic focal ischemia in the rat cortex. Cell Mol Neurobiol. 2009 Sep;29(6-7):827-35. doi: 10.1007/s10571-009-9364-8. Epub 2009 Mar 4.
- Background: PubMed 17014847Zlotnik A, Gurevich B, Tkachov S, Maoz I, Shapira Y, Teichberg VI. Brain neuroprotection by scavenging blood glutamate. Exp Neurol. 2007 Jan;203(1):213-20. doi: 10.1016/j.expneurol.2006.08.021. Epub 2006 Oct 2.
- Background: PubMed 20607387Nagy D, Knapp L, Marosi M, Farkas T, Kis Z, Vecsei L, Teichberg VI, Toldi J. Effects of blood glutamate scavenging on cortical evoked potentials. Cell Mol Neurobiol. 2010 Oct;30(7):1101-6. doi: 10.1007/s10571-010-9542-8. Epub 2010 Jul 6.
- Background: PubMed 27051598Swerdlow RH, Bothwell R, Hutfles L, Burns JM, Reed GA. Tolerability and pharmacokinetics of oxaloacetate 100 mg capsules in Alzheimer's subjects. BBA Clin. 2016 Mar 10;5:120-3. doi: 10.1016/j.bbacli.2016.03.005. eCollection 2016 Jun.
- Background: PubMed 32715609Vidoni ED, Choi IY, Lee P, Reed G, Zhang N, Pleen J, Mahnken JD, Clutton J, Becker A, Sherry E, Bothwell R, Anderson H, Harris RA, Brooks W, Wilkins HM, Mosconi L, Burns JM, Swerdlow RH. Safety and target engagement profile of two oxaloacetate doses in Alzheimer's patients. Alzheimers Dement. 2021 Jan;17(1):7-17. doi: 10.1002/alz.12156. Epub 2020 Jul 27.
- Individual participant dataSharing planned: Yes. The plan is to publish the data so that it is available to other researchers.
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.
Lisa Tully, Ph.D. principal investigator
Energy Medicine Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxaloacetate Medical Food/Dietary Supplement in people with Treatment of Fatigue After Resolution of COVID-19 Infection, run by Terra Biological LLC 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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan B Cash, MS (8589475722, acash@TerraBiological.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 6 weeks). 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 NCT04592354, which also lists 25 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 19 Oct 2020.