COMPLETED

REGAIN: RCT of Oxaloacetate for Fatigue in Long COVID

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

REGAIN: A Randomized, Double Blind, Placebo Controlled Trial to Determine the Effects of Oxaloacetate on Improving Fatigue in Long COVID

Quick Facts

Study Start:2023-06-01
Study Completion:2025-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05840237

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form. Male or female, 18 to 65 years of age. Able to read, understand and voluntarily sign the informed consent form.
  1. * Exclusion Criteria Alternate medical or psychiatric illness that explains Long COVID symptoms in the opinion of the Investigator or sub-investigator.

Contacts and Locations

Principal Investigator

Lucinda Bateman, MD
PRINCIPAL_INVESTIGATOR
Bateman Horne Center

Study Locations (Sites)

Bateman Horne Center
Salt Lake City, Utah, 84102
United States

Collaborators and Investigators

Sponsor: Terra Biological LLC

  • Lucinda Bateman, MD, PRINCIPAL_INVESTIGATOR, Bateman Horne Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2025-01-30

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2025-01-30

Terms related to this study

Keywords Provided by Researchers

  • Long COVID
  • COVID
  • Fatigue
  • Oxaloacetate
  • COVID Fatigue

Additional Relevant MeSH Terms

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