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Medical Food

Oxaloacetate for Post-COVID Syndrome

N/A

Recruiting

Led By Suzanne Vernon, PhD

Research Sponsored by Terra Biological LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients have experienced moderate to severe fatigue at least 50% of the time over the past 6 months that is not relieved by rest and post-exertional malaise (PEM)

Male or female, 18 to 65 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days

Awards & highlights

Study Summary

This trial will test if a drug can help reduce the fatigue and other symptoms in people who have had COVID-19 and now have ME/CFS-like symptoms (aka "Long COVID").

Who is the study for?

This trial is for adults aged 18-65 with Long COVID and symptoms like severe fatigue, brain fog, muscle pains, and sleep issues. Participants must have had these symptoms for at least six months after a confirmed or suspected SARS-CoV-2 infection. They should not be on medications that could affect the study's results and must agree to use contraception if applicable.Check my eligibility

What is being tested?

The REGAIN trial is testing whether Oxaloacetate can reduce fatigue in Long COVID patients who also meet criteria for Chronic Fatigue Syndrome (ME/CFS). It's a randomized study where participants will either receive Oxaloacetate or a placebo made of white rice flour to compare effects.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions to ingredients such as rice flour. As with any medical intervention, there might be unforeseen side effects once the trial begins.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I often feel very tired and resting doesn't help, especially after physical activity.

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I am between 18 and 65 years old.

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I often feel very tired and resting doesn't help, especially after small tasks.

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I have been diagnosed with Long COVID following a COVID-19 infection.

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I can attend all 3 in-person visits required by the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Chalder Fatigue Score

Secondary outcome measures

Global Impression of Change

Up-Time

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oxaloacetate ArmExperimental Treatment1 Intervention

1,000 mg of Anhydrous Enol-Oxaloacetate taken BID with Breakfast and Lunch

Group II: Placebo ArmPlacebo Group1 Intervention

1,000 mg of white Rice Flour taken BID with Breakfast and Lunch

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Terra Biological LLCLead Sponsor

6 Previous Clinical Trials

237 Total Patients Enrolled

Bateman Horne CenterOTHER

2 Previous Clinical Trials

140 Total Patients Enrolled

Suzanne Vernon, PhDPrincipal InvestigatorBateman Horne Center

Media Library

Anhydrous Enol-Oxaloacetate (Medical Food) Clinical Trial Eligibility Overview. Trial Name: NCT05840237 — N/A

Chronic Fatigue Syndrome Clinical Trial 2023: Anhydrous Enol-Oxaloacetate Highlights & Side Effects. Trial Name: NCT05840237 — N/A

Anhydrous Enol-Oxaloacetate (Medical Food) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05840237 — N/A

Chronic Fatigue Syndrome Research Study Groups: Oxaloacetate Arm, Placebo Arm

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial offering opportunities to elderly individuals?

"Patients aged between 18 to 70 are eligible for this trial, while those younger and older will have the option of participating in 16 or 220 clinical trials respectively."

Answered by AI

Who is allowed to participate in this research experiment?

"The ideal candidate for this trial is someone with chronic fatigue syndrome aged between 18 and 70. In total, the researchers are looking to recruit 70 individuals into their study."

Answered by AI

How many participants are actively engaged in this experiment?

"Affirmative. Information made available on clinicaltrials.gov reveals that researchers are actively seeking out potential candidates for this study; it was initially posted on May 1st 2023 and updated recently on April 28th 2021. A total of 70 participants need to be sourced from a single site."

Answered by AI

Is this research endeavor taking on any new recruits at the moment?

"Affirmative. According to the clinicaltrials.gov website, this study is still seeking participants having initially been posted on May 1st 2023 and more recently updated April 28th of the same year. The research team needs 70 people from a single site for enrollment."

Answered by AI