COMPLETED

REGAIN: RCT of Oxaloacetate for Fatigue in Long COVID

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.

Study Overview

Study Details

Study overview

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.

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

REGAIN: RCT of Oxaloacetate for Fatigue in Long COVID

Condition
Post-COVID-19 Syndrome
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Exclusion Criteria Alternate medical or psychiatric illness that explains Long COVID symptoms in the opinion of the Investigator or sub-investigator.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Terra Biological LLC,

Lucinda Bateman, MD, PRINCIPAL_INVESTIGATOR, Bateman Horne Center

Study Record Dates

2025-01-30