deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT05939622

Efficacy of the Therapy With BRAINMAX® Using fMRI for the Treatment of Patients With Asthenia After COVID-19

Prospective Randomized Double Blind Placebo Controlled Study of Efficacy of the Therapy With BRAINMAX® Using Functional Magnetic Resonance Imaging (fMRI) for the Treatment of Patients With Post-COVID Asthenic Syndrome

Sponsor: Promomed, LLC

Updated 4 times since 2023 Last updated: Jul 11, 2023 Started: May 18, 2022 Primary completion: Dec 20, 2022 Completion: Dec 20, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Asthenia and COVID-19 and is currently completed. Promomed, LLC leads this study, which shows 4 recorded versions since 2022 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Study Description(click to expand)

A prospective, randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of therapy using functional MRI of the brain in the setting of neuroprotective therapy for the treatment of patients with chronic fatigue syndrome after COVID-19. The study included 30 patients matched by sex and age with confirmed coronavirus infection. All patients were examined with MFI-20, MoCa, FAS-10 scales, MRI using a Siemens MAGNETOM Prisma 3T scanner before and after a course of therapy with EMHPS-M or placebo (15 patients each) using resting state fMRI and with cognitive paradigm. First group received intramuscularly with the dosage regimen of 5 mL of solution (500 mg of ethyl methyl hydroxypyridine succinate + 500 mg of meldonium) once per day for 10 days. Second group received Placebo in the same way.

A prospective, randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of therapy using functional MRI of the brain in the setting of neuroprotective therapy for the treatment of patients with chronic fatigue syndrome after COVID-19. The study included 30 patients matched by sex and age with confirmed coronavirus infection. All patients were examined with MFI-20, MoCa, FAS-10 scales, MRI using a Siemens MAGNETOM Prisma 3T scanner before and after a course of therapy with EMHPS-M or placebo (15 patients each) using resting state fMRI and with cognitive paradigm. First group received intramuscularly with the dosage regimen of 5 mL of solution (500 mg of ethyl methyl hydroxypyridine succinate + 500 mg of meldonium) once per day for 10 days. Second group received Placebo in the same way.

Status Flow

~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

4 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE4

    First recorded

May 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Promomed, LLC
Data source: Promomed, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations