COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04592354

Alan B Cash, MS

acash@TerraBiological.com

2020-10-19

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Long covid

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.

- 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.

2

Terra Biological LLC

18

65

United States

Patients recovered from covid

N/A

40

Fatigue

None

Not reported

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