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REGAIN: RCT of Oxaloacetate for Fatigue in Long COVID

NCT05840237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-02-04

No results posted yet for this study

Summary

Following acute COVID-19, some patients develop a group of debilitating symptoms that include fatigue, orthostatic intolerance, difficulty with attention and concentration (often called "brain fog"), myalgias and disrupted sleep. The term Long COVID is used to describe these symptoms after the initial viral infection has passed. These symptoms are the same as those that define myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

A "Proof of Concept" trial showed significant fatigue benefit in Long COVID patients. This randomized, placebo controlled follow-on trial will determine whether oxaloacetate can reduce fatigue and improve other symptoms in patients with Long COVID who meet diagnostic criteria for ME/CFS.

Conditions

  • Post-COVID-19 Syndrome
  • Fatigue Syndrome, Chronic

Interventions

OTHER

Anhydrous Enol-Oxaloacetate, a "Medical Food"

Treatment with the medical food "Oxaloacetate CFS", 2 - 500 mg capsules BID with food

OTHER

White Rice Flour

Treatment with the food "White Rice Flour", 2- 500 mg capsules BID with food

Sponsors & Collaborators

  • Bateman Horne Center

    collaborator OTHER

  • Terra Biological LLC

    lead INDUSTRY

Principal Investigators

  • Lucinda Bateman, MD · Bateman Horne Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05840237 on ClinicalTrials.gov