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NCT05840237
REGAIN: RCT of Oxaloacetate for Fatigue in Long COVID
NA trial testing Anhydrous Enol-Oxaloacetate, a "Medical Food" in Post-COVID-19 Syndrome in 70 participants. Completed in 30 January 2025.
30 January 2025
Quick facts
| Lead sponsor | Terra Biological LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 June 2023 |
| Primary completion | 30 January 2025 |
| Estimated completion | 30 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Anhydrous Enol-Oxaloacetate, a "Medical Food"
- White Rice Flour
Conditions studied
- Post-COVID-19 Syndrome — all drugs for Post-COVID-19 Syndrome →
- Fatigue Syndrome, Chronic — all drugs for Fatigue Syndrome, Chronic →
Sponsor
Terra Biological LLC
Who can join
Adults 18 to 70, any sex, with Post-COVID-19 Syndrome or Fatigue Syndrome, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
REGAIN: a randomized controlled clinical trial of oxaloacetate for improving the symptoms of long COVID.
Vernon SD, Rond C, Bell J, Butler B, et al · · 2025 · PMID 40757370 · DOI 10.3389/fnins.2025.1627462
Verify or expand the search:
- PubMed search for NCT05840237
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Post-COVID-19 Syndrome
Currently open trials in the same condition.
- NCT06156176 — Pursuing Reduction in Fatigue After COVID-19 Via Exercise and Rehabilitation (PREFACER): A Randomized Feasibility Trial · NA · recruiting
- NCT06231238 — Balance Acceptance and Commitment Therapy for Long COVID · NA · active not recruiting
- NCT06042751 — Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom · NA · active not recruiting
- NCT06073002 — Effects of a Home-Based Exercise Intervention in Subjects with Long COVID · NA · active not recruiting
- NCT05890599 — Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome · NA · recruiting
Other Terra Biological LLC trials
Trials by the same sponsor.
- NCT05273372 — RESTORE ME -- RCT of Oxaloacetate on Improving Fatigue in ME/CFS · NA · completed
- NCT04592354 — Anhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors · NA · unknown
- NCT03509714 — Oxaloacetate Supplementation for Emotional PMS · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05840237 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Terra Biological LLC
- Last refreshed: 4 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05840237.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing