Clinical trial NCT04592354: Anhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors
Official title: Anhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment of Fatigue After Resolution of COVID-19 Infection
Lead sponsor: Terra Biological LLC
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blinded placebo controlled comparison study
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fatigue
timeFrame: 6 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 6 weeks
measure: Depression
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Energy Medicine research Institute
state: Colorado
Study officials:
affiliation: Energy Medicine Research Institute
name: Lisa Tully, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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