NCT04592354: AEO

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

Status unknown NA Last updated 19 October 2020

What this trial tests

NA trial testing Oxaloacetate Medical Food/Dietary Supplement in Treatment of Fatigue After Resolution of COVID-19 Infection in 40 participants. Status unknown.

Timeline

15 October 2020

Primary endpoint
15 April 2021

15 June 2021

Quick facts

Lead sponsor	Terra Biological LLC
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	15 October 2020
Primary completion	15 April 2021
Estimated completion	15 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Oxaloacetate Medical Food/Dietary Supplement

Conditions studied

• Treatment of Fatigue After Resolution of COVID-19 Infection — all drugs for Treatment of Fatigue After Resolution of COVID-19 Infection →

Sponsor

Terra Biological LLC

Who can join

Adults 18 to 65, female only, with Treatment of Fatigue After Resolution of COVID-19 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trials on the pharmacological treatment of long COVID: A systematic review.
   Chee YJ, Fan BE, Young BE, Dalan R, et al · · 2023 · cited 55× · PMID 36349400 · DOI 10.1002/jmv.28289
2. Oxaloacetate Treatment For Mental And Physical Fatigue In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long-COVID fatigue patients: a non-randomized controlled clinical trial.
   Cash A, Kaufman DL. · · 2022 · cited 42× · PMID 35764955 · DOI 10.1186/s12967-022-03488-3