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

NCT05689827 | Completed Phase 4

• 1 other identifier: BRAINMAX_ 2021
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 6

Brief 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)

Conditions

Asthenia; COVID-19

Outcome Measures

Primary Outcomes (1)

• Asthenia on a scale Multidimensional Fatigue Inventory (MFI-20) after the completion of the sequential therapy

  Mean decrease of MFI-20 asthenia scale score after the completion of the sequential therapy

  From baseline to Visit 5 (day 41)

Secondary Outcomes (18)

• Asthenia on a scale MFI-20 after the completion of the parenteral therapy

  From baseline to Visit 3 (day 11)

• Asthenia on a scale MFI-20 after the completion of the oral therapy

  From Visit 3 (day 11) to Visit 5 (day 41)

• Headache on a visual analogue scale (VAS) after the completion of the sequential therapy

  From baseline to Visit 5 (day 41)

• Headache on a VAS after the completion of the parenteral therapy

  From baseline to Visit 3 (day 11)

• Headache on a VAS after the completion of the oral therapy

  From Visit 3 (day 11) to Visit 5 (day 41)

Study Arms (2)

Ethyl methyl hydroxypyridine succinate + Meldonium

EXPERIMENTAL

Arm 1 (n=80) 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.

Drug: Ethyl methyl hydroxypyridine succinate + Meldonium

Placebo

PLACEBO COMPARATOR

Arm 2 (n=80) received Placebo in the same way.

Drug: Placebo

Interventions

Ethyl methyl hydroxypyridine succinate + Meldonium DRUG

Ethyl methyl hydroxypyridine succinate 100.0 mg/mL, meldonium dihydrate - 100.0 mg/mL (Solution for intravenous and intramuscular administration), then Ethyl methyl hydroxypyridine succinate - 250.0 mg, meldonium dihydrate based on dihydrate without adsorption moisture - 250.0 mg (oral capsules)

Also known as: BRAINMAX®

Ethyl methyl hydroxypyridine succinate + Meldonium

Placebo DRUG

Placebo was used in the same way

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients able to sign the patient informed consent form for the participation in the clinical study
• Patients of both sexes of 18-65 years of age
• Patient's negative test result for severe acute respiratory syndrome (SARS) -CoV-2 RNA obtained by polymerase chain reaction (PCR) method within 72 hours
• COVID-19 diagnosis documented in the history more than 12 weeks ago\*
• 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
• Patients capable of following the requirements of the Clinical Study Protocol
• Negative pregnancy test result (for women with the active childbearing potential)
• MFI-20 scale score is more than 30 at the moment of screening.

You may not qualify if:

• Allergic reactions to the components of the study product
• Oxygen saturation by pulse oximetry (SpO2) oxygen saturation ≤ 95%
• Depression level score by Hamilton Depression Rating Scale (HDRS) at the screening ≥ 8
• Intracranial pressure rise (for the reason of venous outflow disorder and intracranial tumours)
• Severe hepatic failure
• Severe renal failure
• Chronic liver and hepatic diseases
• Thyroid diseases
• Anaemia
• Autoimmune diseases
• Other chronical diseases which, according to the investigator, can cause asthenia
• G lomerular filtration rate (GFR) parameter at screening \< 30 mL/min
• Pregnancy or lactation period
• Participation in any other clinical study during the last 3 months
• Tuberculosis, cancers or positive reaction to the HIV infection, hepatitis B \& C, syphilis according to the history data

Sponsors & Collaborators

• Promomed, LLC: lead

Study Sites (6)

Federal State Budgetary Research Institution "Research Centre of Neurology"

Moscow, Russia

Location

OsteoVita LLC

Saint Petersburg, Russia

Location

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

Sestroretsk, Russia

Location

Centre For Evidence-Based Medicine Llc

Yaroslavl, Russia

Location

Medical Centre of Diagnostics and Prevention Plus LLC

Yaroslavl, Russia

Location

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

Yaroslavl, Russia

Location

Related Publications (1)

• Tanashyan MM, Raskurazhev AA, Kuznetsova PI, Bely PA, Zaslavskaya KI. [Prospects and possibilities for the treatment of patients with long COVID-19 syndrome]. Ter Arkh. 2022 Dec 26;94(11):1285-1293. doi: 10.26442/00403660.2022.11.201981. Russian.

  PMID: 37167167 BACKGROUND

Related Links

• Cyberleninka is an open access scientific electronic library

MeSH Terms

Conditions

Asthenia; COVID-19

Interventions

3-(2,2,2-trimethylhydrazine)propionate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 19, 2023
• Study Start: April 5, 2022
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (6)