Trial intelligence / Profile preview

Evaluating the Neuromodulatory Effect of Ketamine in Long COVID

NCT06821087Phase 2

Key facts

Status
Completed
Start
Jun 2025
Primary completion
Jun 2026
Countries
1
Sponsor
University of Texas at Austin
Modality
Small Molecules
Conditions
post-COVID-19 condition (PCC)
01

Overview

Phase 2, open-label, single-arm trial of ketamine in post-COVID-19 condition (PCC), sponsored by University of Texas at Austin. Primary endpoints: PROMIS SF v1.0 - Fatigue 8a at 8 weeks and PROMIS SF v2.0 Cognitive Function 4a at 8 weeks. Started Jun 2025; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Ketamine Therapy

    Four IM ketamine injections over a two-week period.

03

Who it enrols

Adults aged 18-65 with Long COVID and persistent fatigue or neurocognitive dysfunction, excluding those with severe psychiatric disorders, unstable cardiovascular disease, or recent use of benzodiazepines or naltrexone.

04

Endpoints

Primary

  • PROMIS SF v1.0 - Fatigue 8a

  • PROMIS SF v2.0 Cognitive Function 4a

Secondary

  • PROMIS Global 10 v1.2

  • NASA Task Load Index

  • Patient Health Questionnaire-9

  • Number of participants with treatment-related adverse events

  • BrainCheck Cognitive Battery

  • Generalized Anxiety Disorder-7

  • Depression in Medically Ill 10 Scale

  • Long COVID Review of Systems

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