NCT04592354

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Terra Biological LLC · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment of Fatigue After Resolution of COVID-19 Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oxaloacetate Medical Food/Dietary Supplement	500 mg Anhydrous Enol-Oxaloacetate BID

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-04-15
• Completion: 2021-06-15
• First posted: 2020-10-19
• Last updated: 2020-10-19

Locations

1 site across 1 country: United States