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

Inclusion Criteria:

• 4.1.1 Women with an initial infection diagnosis COVID-19 that has been resolved, asmeasured 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 greateron the Fatigue Questionnaire.

• 4.1.4 Is geographically accessible, or can fill out forms virtually, and able toparticipate 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 recommendedtherapeutic dose are unknown. For this reason, women of childbearing potential mustagree 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 whohave had their ovaries and/or uterus removed will not be at risk for pregnancy andwill not require contraception. Should a woman become pregnant or suspect she ispregnant while participating in this study, she should inform her study physicianimmediately.

• Menopausal status will be established as follows: Women who are 55 years or olderand who are not menstruating will be considered postmenopausal and not at riskfor pregnancy. Women who are less than 55 years old who are menstruating will beconsidered premenopausal and will require contraception. Women who are less than 55 years with an intact uterus and ovaries who are not menstruating and have nothad a menstrual period within the past 2 years will have an FSH and estradiolmeasured. If the values are in postmenopausal range the woman will be consideredpostmenopausal and she will not be considered at risk for pregnancy.

• 4.1.8 Ability to understand and the willingness to sign a written informed consentdocument.

• 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 contributesto substantial physical or emotional disability that would detract from participatingin the planned study.

• 4.2.2 Taking chronic medications that would interfere with cognitive functioning suchas medications for sleep, anxiety, narcotics for pain, use of illicit medical foods orcannabis.

• 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 orbiologic composition to oxaloacetate.

• 4.2.5 Uncontrolled intercurrent illness including, but not limited to, ongoing oractive infection of Covid-19 or other virus, symptomatic congestive heart failure,unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situationsthat would limit compliance with study requirements.

• 4.2.6 Pregnant or breast-feeding women are excluded from this study because the safetyof oxaloacetate in this setting is unknown. A pregnancy test will be performed on allwomen with an intact uterus and ovaries who are not determined to be postmenopausal,as described in section 4.1.7.