Post-COVID-19 SyndromeNCT05840237
REGAIN: RCT of Oxaloacetate for Fatigue in Long COVID
A study testing Anhydrous Enol-Oxaloacetate, a "Medical Food" and White Rice Flour in people with Post-COVID-19 Syndrome and Fatigue Syndrome, Chronic, run by Terra Biological LLC at 1 site in United States.
Trial summary
Following acute COVID-19, some patients develop a group of debilitating symptoms that include fatigue, orthostatic intolerance, difficulty with attention and concentration (often called "brain fog"), myalgias and disrupted sleep. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-COVID-19 Syndrome, Fatigue Syndrome, Chronic
- What is being tested?
- Anhydrous Enol-Oxaloacetate, a "Medical Food" and White Rice Flour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Jan 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form. Male or female, 18 to 65 years of age. Able to read, understand and voluntarily sign the informed consent form.
- Diagnosed with Long COVID by a provider after suspected, probable or confirmed infection with SARS-CoV-2 as defined by the WHO (see full protocol for details). Patients have experienced moderate to severe fatigue at least 50% of the time over the past 6 months that is not relieved by rest and post-exertional malaise (PEM) which is unusual worsening of symptoms after minimal physical or cognitive exertion, which can occur or persist 24 hours or more after the exertion.
- Agree to refrain from taking medications that would affect assessment of the effectiveness of study IP for the duration of the study.
- Females of childbearing potential should be on adequate contraception such as oral, implantable, injectable or transdermal hormonal contraceptives (should have been used for a minimum of one full cycle prior to administration of study drug), intrauterine devices (IUD), vasectomized partner, double barrier method (male or female condom, sponge, diaphragm or vaginal ring with simultaneous use of spermicidal jelly or cream).
- Each patient of child-bearing potential must have a negative urine pregnancy test at Visit 1. The urine test at Visit 1 must be confirmed negative prior to dispensing IP. Women of child-bearing potential will have a urine pregnancy test at each visit (2 and 3) and it must be negative to continue. Women who are confirmed to be of non-childbearing potential do not require pregnancy testing. To be considered of non-child-bearing potential, the patient must be: post-menopausal (defined as no menses for at least one year); or surgically sterile (s/p hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months prior to randomization); or at least 3 months s/p a non-surgical permanent sterilization procedure.
- Stated willingness to comply with all study procedures. Be available and appear for the 3 in-person visits of the study. Have mobile (smart) phone and access to the internet. Willingness to wear a device on their ankle.
Who cannot join
- Exclusion Criteria Alternate medical or psychiatric illness that explains Long COVID symptoms in the opinion of the Investigator or sub-investigator.
- Active or uncontrolled co-morbidities (including depression, untreated endocrine diagnoses), which may interfere with the ability of the patient to participate in the study in the opinion of the Principal Investigator or Sub-Investigator.
- Body Mass Index >40 Known allergy to rice flour. Any investigational drug use in the past 30 days. Fatigue improvement because of a current treatment intervention. Treatment within the past 14 days or current treatment with stimulants including methylphenidate, amphetamine-dextroamphetamine, phentermine, lisdexamfetamine, modafinil, and armodafinil Previous or current use of oxaloacetate. Pregnancy, or while breast feeding. Women should not be enrolled within 6 months of giving birth and within 3 months of cessation of breast feeding.
- Past medical history of:
- Untreated or uncontrolled major depressive disorder, untreated or uncontrolled endocrine diagnoses including hypothyroidism (Hashimoto's, etc.), Grave's disease, adrenal insufficiency, hypogonadism (testosterone deficiency), diabetes mellitus or insipidus.
- In the last 3 years have they experienced a concussion with loss of consciousness, brain surgery, an automobile accident with head/neck injury, and/or other traumatic brain injury.
- Active supra-ventricular tachycardia or ventricular tachycardia, e.g., atrial fibrillation or flutter, paroxysmal atrial fibrillation, junctional tachycardia, ventricular tachycardia.
- Symptomatic hypotension defined as rested sitting systolic BP < 90 mmHg or rested sitting diastolic BP < 60 mmHg, Substance abuse in the past 12 months as determined by self-report or in the opinion of the PI and Sub-I
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REGAIN: A Randomized, Double Blind, Placebo Controlled Trial to Determine the Effects of Oxaloacetate on Improving Fatigue in Long COVID
Following acute COVID-19, some patients develop a group of debilitating symptoms that include fatigue, orthostatic intolerance, difficulty with attention and concentration (often called "brain fog"), myalgias and disrupted sleep. The term Long COVID is used to describe these symptoms after the initial viral infection has passed. These symptoms are the same as those that define myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
A "Proof of Concept" trial showed significant fatigue benefit in Long COVID patients. This randomized, placebo controlled follow-on trial will determine whether oxaloacetate can reduce fatigue and improve other symptoms in patients with Long COVID who meet diagnostic criteria for ME/CFS.
Read the detailed description
Following acute COVID-19, some patients develop a group of debilitating symptoms that include fatigue, orthostatic intolerance, difficulty with attention and concentration (often called "brain fog"), myalgias and disrupted sleep (1-8). The term Long COVID is used to describe the prolonged multisystem illness that occurs after acute infection with SARS-CoV-2. The frequency with which this syndrome occurs following acute COVID-19 ranges from 2-40% of cases (8, 9). Although individuals with more severe acute COVID-19 are more likely to develop Long COVID, it is prevalent in people who were mildly symptomatic or asymptomatic at the time of acute infection with SARS-CoV-2 (8, 10, 11).
Many people with Long COVID remain ill for many months. Currently there are thousands of people in the U.S. that have been suffering with Long COVID for the past three years since the onset of the COVID-19 pandemic in January 2020 (12). In a recent study, the Imperial College in London estimated that there are 2 million adults suffering from Long COVID in the UK (13). According to the US News, Long COVID has become the 'Pandemic After the Pandemic (14). There is evidence that diagnosis and treatment early in the course of illness improves the likelihood of recovery and sustained remission of post-infectious illness (15, 16).
A code U09.9 was added to ICD-10 in October 2021 to document post-acute sequela of COVID-19 after infection and Long COVID. The WHO published a Long COVID clinical case definition coincident with the ICD code that described the common symptoms of Long COVID including fatigue, shortness of breath, cognitive dysfunction but also others and these generally have an impact on everyday functioning (17). The signs and symptoms described in this case definition were also described in survey responses from an international cohort of more than 6,000 people with Long COVID (18). This study found that signs and symptoms that persisted more than 6 months of illness included fatigue, brain fog, post-exertional malaise, insomnia, joint and muscle pain, orthostatic intolerance, gastrointestinal symptoms, and sensorimotor symptoms including tremors and nerve pain. These symptoms are the same as those that define myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). ME/CFS is defined by the National Academy of Medicine as a substantial reduction or impairment in the ability to engage in pre-illness levels of activity (occupational, educational, social, or personal life) that lasts for more than 6 months and is accompanied by profound fatigue of new onset that is not a result of ongoing or unusual excessive exertion and is not alleviated by rest; post-exertional malaise (PEM) which is the worsening of symptoms after physical, mental, or emotional exertion that would not have caused a problem before the illness; unrefreshing sleep; and at least one of the following two additional manifestations must be present, cognitive impairment or orthostatic intolerance (18).
Oxaloacetate is an energy metabolite found in every cell of the human body. It holds a key place in the TCA cycle within the mitochondria, providing energy to the cells. It is also a critical early metabolite in gluconeogenesis, which provides glucose for the heart and brain during times of low glucose. In addition, oxaloacetate is found in the urea cycle (which converts toxic ammonia to urea), amino acid synthesis, and fatty acid synthesis. It is critical to human metabolism and proper cellular function, and it is central to energy production and use in the body.
A "Proof of Concept" trial showed significant fatigue benefit in Long COVID patients. This randomized, placebo controlled follow-on trial will determine whether oxaloacetate can reduce fatigue and improve other symptoms in patients with Long COVID who meet diagnostic criteria for ME/CFS.
- Conditions
- Post-COVID-19 Syndrome, Fatigue Syndrome, Chronic
- Being tested
- Anhydrous Enol-Oxaloacetate, a "Medical Food", White Rice Flour
- Keywords
- Long COVID, COVID, Fatigue, Oxaloacetate, COVID Fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anhydrous Enol-Oxaloacetate, a "Medical Food"Other
Also called Oxaloacetate, Oxaloacetate CFS
Treatment with the medical food "Oxaloacetate CFS", 2 - 500 mg capsules BID with food
White Rice FlourOther
Also called Rice Flour
Treatment with the food "White Rice Flour", 2- 500 mg capsules BID with food
| Study group | Role | What they receive |
|---|---|---|
| Oxaloacetate Arm | Experimental | 1,000 mg of Anhydrous Enol-Oxaloacetate taken BID with Breakfast and Lunch Receives: Other: Anhydrous Enol-Oxaloacetate, a "Medical Food" |
| Placebo Arm | Placebo comparator | 1,000 mg of white Rice Flour taken BID with Breakfast and Lunch Receives: Other: White Rice Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chalder Fatigue Score
A Validated patient derived survey of fatigue
Measured: 42 days
Secondary outcomes (2)
Global Impression of Change
A Validated patient derived survey for overall improvment
Measured: 42 days
Up-Time
Measurement of physical activity with a device attached to the ankle
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2023
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies 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
- Single Center, Randomized, Placebo Controlled, Double Blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terra Biological LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bateman Horne Center
- Responsible party
- Sponsor
- Investigators
- Lucinda Bateman, MD, Principal investigator, Bateman Horne Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840237
- Sponsor's protocol ID
- TB-2023-AEO LC
- Status last verified
- Nov 2024
- First submitted
- 28 Apr 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cash A, Kaufman DL. Oxaloacetate Treatment For Mental And Physical Fatigue In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long-COVID fatigue patients: a non-randomized controlled clinical trial. J Transl Med. 2022 Jun 28;20(1):295. doi: 10.1186/s12967-022-03488-3.
PubMed 35764955
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REGAIN: A Randomized, Double Blind, Placebo Controlled Trial to Determine the Effects of Oxaloacetate on Improving Fatigue in Long COVID
- ClinicalTrials.gov ID
- NCT05840237
- Acronym / sponsor ID
- TB-2023-AEO LC
- Conditions
- Post-COVID-19 Syndrome, Fatigue Syndrome, Chronic
- Keywords
- Long COVID, COVID, Fatigue, Oxaloacetate, COVID Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Terra Biological LLCIndustry (pharma, biotech, devices)
- Collaborators
- Bateman Horne Center
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 3 May 2023 (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.
Following acute COVID-19, some patients develop a group of debilitating symptoms that include fatigue, orthostatic intolerance, difficulty with attention and concentration (often called "brain fog"), myalgias and disrupted sleep. The term Long COVID is used to describe these symptoms after the initial viral infection has passed. These symptoms are the same as those that define myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
A "Proof of Concept" trial showed significant fatigue benefit in Long COVID patients. This randomized, placebo controlled follow-on trial will determine whether oxaloacetate can reduce fatigue and improve other symptoms in patients with Long COVID who meet diagnostic criteria for ME/CFS.
Detailed description
Following acute COVID-19, some patients develop a group of debilitating symptoms that include fatigue, orthostatic intolerance, difficulty with attention and concentration (often called "brain fog"), myalgias and disrupted sleep (1-8). The term Long COVID is used to describe the prolonged multisystem illness that occurs after acute infection with SARS-CoV-2. The frequency with which this syndrome occurs following acute COVID-19 ranges from 2-40% of cases (8, 9). Although individuals with more severe acute COVID-19 are more likely to develop Long COVID, it is prevalent in people who were mildly symptomatic or asymptomatic at the time of acute infection with SARS-CoV-2 (8, 10, 11).
Many people with Long COVID remain ill for many months. Currently there are thousands of people in the U.S. that have been suffering with Long COVID for the past three years since the onset of the COVID-19 pandemic in January 2020 (12). In a recent study, the Imperial College in London estimated that there are 2 million adults suffering from Long COVID in the UK (13). According to the US News, Long COVID has become the 'Pandemic After the Pandemic (14). There is evidence that diagnosis and treatment early in the course of illness improves the likelihood of recovery and sustained remission of post-infectious illness (15, 16).
A code U09.9 was added to ICD-10 in October 2021 to document post-acute sequela of COVID-19 after infection and Long COVID. The WHO published a Long COVID clinical case definition coincident with the ICD code that described the common symptoms of Long COVID including fatigue, shortness of breath, cognitive dysfunction but also others and these generally have an impact on everyday functioning (17). The signs and symptoms described in this case definition were also described in survey responses from an international cohort of more than 6,000 people with Long COVID (18). This study found that signs and symptoms that persisted more than 6 months of illness included fatigue, brain fog, post-exertional malaise, insomnia, joint and muscle pain, orthostatic intolerance, gastrointestinal symptoms, and sensorimotor symptoms including tremors and nerve pain. These symptoms are the same as those that define myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). ME/CFS is defined by the National Academy of Medicine as a substantial reduction or impairment in the ability to engage in pre-illness levels of activity (occupational, educational, social, or personal life) that lasts for more than 6 months and is accompanied by profound fatigue of new onset that is not a result of ongoing or unusual excessive exertion and is not alleviated by rest; post-exertional malaise (PEM) which is the worsening of symptoms after physical, mental, or emotional exertion that would not have caused a problem before the illness; unrefreshing sleep; and at least one of the following two additional manifestations must be present, cognitive impairment or orthostatic intolerance (18).
Oxaloacetate is an energy metabolite found in every cell of the human body. It holds a key place in the TCA cycle within the mitochondria, providing energy to the cells. It is also a critical early metabolite in gluconeogenesis, which provides glucose for the heart and brain during times of low glucose. In addition, oxaloacetate is found in the urea cycle (which converts toxic ammonia to urea), amino acid synthesis, and fatty acid synthesis. It is critical to human metabolism and proper cellular function, and it is central to energy production and use in the body.
A "Proof of Concept" trial showed significant fatigue benefit in Long COVID patients. This randomized, placebo controlled follow-on trial will determine whether oxaloacetate can reduce fatigue and improve other symptoms in patients with Long COVID who meet diagnostic criteria for ME/CFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Single Center, Randomized, Placebo Controlled, Double Blind
| Arm | Type | Receives |
|---|---|---|
| Oxaloacetate Arm | Experimental | Other: Anhydrous Enol-Oxaloacetate, a "Medical Food"1,000 mg of Anhydrous Enol-Oxaloacetate taken BID with Breakfast and Lunch |
| Placebo Arm | Placebo comparator | Other: White Rice Flour1,000 mg of white Rice Flour taken BID with Breakfast and Lunch |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form. Male or female, 18 to 65 years of age. Able to read, understand and voluntarily sign the informed consent form.
- Diagnosed with Long COVID by a provider after suspected, probable or confirmed infection with SARS-CoV-2 as defined by the WHO (see full protocol for details). Patients have experienced moderate to severe fatigue at least 50% of the time over the past 6 months that is not relieved by rest and post-exertional malaise (PEM) which is unusual worsening of symptoms after minimal physical or cognitive exertion, which can occur or persist 24 hours or more after the exertion.
- Agree to refrain from taking medications that would affect assessment of the effectiveness of study IP for the duration of the study.
- Females of childbearing potential should be on adequate contraception such as oral, implantable, injectable or transdermal hormonal contraceptives (should have been used for a minimum of one full cycle prior to administration of study drug), intrauterine devices (IUD), vasectomized partner, double barrier method (male or female condom, sponge, diaphragm or vaginal ring with simultaneous use of spermicidal jelly or cream).
- Each patient of child-bearing potential must have a negative urine pregnancy test at Visit 1. The urine test at Visit 1 must be confirmed negative prior to dispensing IP. Women of child-bearing potential will have a urine pregnancy test at each visit (2 and 3) and it must be negative to continue. Women who are confirmed to be of non-childbearing potential do not require pregnancy testing. To be considered of non-child-bearing potential, the patient must be: post-menopausal (defined as no menses for at least one year); or surgically sterile (s/p hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months prior to randomization); or at least 3 months s/p a non-surgical permanent sterilization procedure.
Key exclusion criteria (8 listed)
- Exclusion Criteria Alternate medical or psychiatric illness that explains Long COVID symptoms in the opinion of the Investigator or sub-investigator.
- Active or uncontrolled co-morbidities (including depression, untreated endocrine diagnoses), which may interfere with the ability of the patient to participate in the study in the opinion of the Principal Investigator or Sub-Investigator.
- Body Mass Index >40 Known allergy to rice flour. Any investigational drug use in the past 30 days. Fatigue improvement because of a current treatment intervention. Treatment within the past 14 days or current treatment with stimulants including methylphenidate, amphetamine-dextroamphetamine, phentermine, lisdexamfetamine, modafinil, and armodafinil Previous or current use of oxaloacetate. Pregnancy, or while breast feeding. Women should not be enrolled within 6 months of giving birth and within 3 months of cessation of breast feeding.
- Untreated or uncontrolled major depressive disorder, untreated or uncontrolled endocrine diagnoses including hypothyroidism (Hashimoto's, etc.), Grave's disease, adrenal insufficiency, hypogonadism (testosterone deficiency), diabetes mellitus or insipidus.
- In the last 3 years have they experienced a concussion with loss of consciousness, brain surgery, an automobile accident with head/neck injury, and/or other traumatic brain injury.
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 |
|---|---|---|
| Anhydrous Enol-Oxaloacetate, a "Medical Food"Also: Oxaloacetate, Oxaloacetate CFSTreatment with the medical food "Oxaloacetate CFS", 2 - 500 mg capsules BID with food | Other | Oxaloacetate Arm |
| White Rice FlourAlso: Rice FlourTreatment with the food "White Rice Flour", 2- 500 mg capsules BID with food | Other | Placebo Arm |
Primary outcome
Chalder Fatigue Score
Time frame: 42 days
A Validated patient derived survey of fatigue
2 secondary outcomes
Global Impression of Change
Time frame: 42 days
Up-Time
Time frame: 42 days
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 4 Feb 2025.
- Results publication: PubMed 35764955Cash A, Kaufman DL. Oxaloacetate Treatment For Mental And Physical Fatigue In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long-COVID fatigue patients: a non-randomized controlled clinical trial. J Transl Med. 2022 Jun 28;20(1):295. doi: 10.1186/s12967-022-03488-3.
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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.
Lucinda Bateman, MD principal investigator
Bateman Horne Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anhydrous Enol-Oxaloacetate, a "Medical Food" and White Rice Flour in people with Post-COVID-19 Syndrome and Fatigue Syndrome, Chronic, 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 6 inclusion and 8 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 4 Feb 2025. 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?
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?
Chalder Fatigue Score (time frame: 42 days). 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 NCT05840237, which also lists 1 linked publication.
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 4 Feb 2025.