Recruiting

Anhydrous Enol-OxaloacetateAnhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors

Sponsor:

Terra Biological LLC

Code:

NCT04592354

Conditions

Treatment of Fatigue After Resolution of COVID-19 Infection

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Oxaloacetate Medical Food/Dietary Supplement

Study Details

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.

Conditions

Treatment of Fatigue After Resolution of COVID-19 Infection

Study ID

NCT04592354

Start date

Oct 15, 2020

Status verified date

Oct, 2020

Completion date

Jun 15, 2021

Anticipated

Primary completion date

Apr 15, 2021

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Oxaloacetate Therapeutic Arm

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 comparator: Placebo Arm

Rice Flour
A 500 mg rice flour capsule taken by mouth twice a day

Interventions

Oxaloacetate Medical Food/Dietary Supplement

500 mg Anhydrous Enol-Oxaloacetate BID

Primary outcome measure

Fatigue [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Alan B Cash, MS

8589475722 acash@TerraBiological.com

Locations

Energy Medicine research Institute

Recruiting

Boulder, Colorado, United States, 80304

Contacts

Lisa Tully, Ph.D.

303-440-3649 lisa@energymedicineri.com

More Information

Sponsor

Terra Biological LLC

Last update posted

Oct 19, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Terra Biological LLC on 2020-10-19.