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COMPLETEDPHASE4

Safety and Efficacy of the Therapy With BRAINMAX® for the Treatment of Patients With Asthenia After COVID-19

Prospective Multicentre Comparative Randomized Double Blind Placebo Controlled Study of Safety and Efficacy of the Therapy With BRAINMAX® for the Treatment of Patients With Asthenia After Having the Novel Coronavirus Infection (COVID-19)

NCT05689827•Promomed, LLC

View on ClinicalTrials.gov

Summary

This is prospective multicentre comparative randomized double blind placebo controlled study conducted in 6 medical facilities.The objective of the study is to assess the safety and efficacy of the sequential therapy with BRAINMAX®, solution for intravenous infusion and intramuscular injection, and BRAINMAX®, capsules for the treatment of patients with asthenia after having the novel coronavirus infection (COVID-19)

Detailed Description

Upon signing the informed consent form and screening, 160 eligible patients from 18 to 65 years of age with asthenia after having the novel coronavirus infection (COVID-19) were randomized at a 1:1 ratio. 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; total number of injections for the treatment course is 10 and then orally with the dosage regimen of 2 capsules (500 mg of ethyl methyl hydroxypyridine succinate + 500 mg of meldonium) twice per day for 30 days; total number of capsules for the treatment course is 120. Second group received Placebo in the same way.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients able to sign the patient informed consent form for the participation in the clinical study
•2. Patients of both sexes of 18-65 years of age
•3. Patient's negative test result for severe acute respiratory syndrome (SARS) -CoV-2 RNA obtained by polymerase chain reaction (PCR) method within 72 hours
•4. COVID-19 diagnosis documented in the history more than 12 weeks ago\*
•5. Minimum two symptoms of asthenic state: fatigue, atony, dizziness, sleeping disorder, feeling of energy loss and decreased functioning, intellectual function disorder, attention and memory disorder, which appeared during or after COVID-19, retain for more than 12 weeks and cannot be explained by an alternative diagnosis
•6. Patients capable of following the requirements of the Clinical Study Protocol
•7. Negative pregnancy test result (for women with the active childbearing potential)
•8. MFI-20 scale score is more than 30 at the moment of screening.

Exclusion Criteria

•1. Allergic reactions to the components of the study product
•2. Oxygen saturation by pulse oximetry (SpO2) oxygen saturation ≤ 95%
•3. Depression level score by Hamilton Depression Rating Scale (HDRS) at the screening ≥ 8
•4. Intracranial pressure rise (for the reason of venous outflow disorder and intracranial tumours)
•5. Severe hepatic failure
•6. Severe renal failure
•7. Chronic liver and hepatic diseases
•8. Thyroid diseases
•9. Anaemia
•10. Malignant tumour of any localization currently or during 5 years before the inclusion into the study except for completely treated carcinoma in situ
+21 more criteria

Locations (6)

Federal State Budgetary Research Institution "Research Centre of Neurology"

Moscow, Russia

OsteoVita LLC

Saint Petersburg, Russia

Saint Petersburg State Budgetary Healthcare Institution "Municipal Hospital No. 40 of Kurortny District"

Sestroretsk, Russia

Centre For Evidence-Based Medicine Llc

Yaroslavl, Russia

Medical Centre of Diagnostics and Prevention Plus LLC

Yaroslavl, Russia

State Budgetary Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Hospital for War Veterans - International Elderly People Centre 'Zdorovoe Dolgoletie'

Yaroslavl, Russia

Key Dates

Start Date

April 5, 2022

Primary Completion Date

November 10, 2022

Completion Date

November 10, 2022

Last Updated

July 13, 2023

Enrollment

160

ACTUAL participants

Conditions

AstheniaCOVID-19

Interventions

Ethyl methyl hydroxypyridine succinate + Meldonium

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of the Therapy With BRAINMAX® for the Treatment of Patients With Asthenia After COVID-19

Inclusion Criteria

Exclusion Criteria

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