AstheniaPhase 4NCT05689827
Safety and Efficacy of the Therapy With BRAINMAX® for the Treatment of Patients With Asthenia After COVID-19
A Phase 4 study testing Ethyl methyl hydroxypyridine succinate + Meldonium in people with Asthenia and COVID-19, run by Promomed, LLC at 6 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Ethyl methyl hydroxypyridine succinate + Meldonium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 6 sitesRussia
- Study dates
- 5 Apr 2022to 10 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 31Show fewer
- Chronic liver and hepatic diseases
- Thyroid diseases
- Anaemia
- Malignant tumour of any localization currently or during 5 years before the inclusion into the study except for completely treated carcinoma in situ
- 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
- Severe eyesight and/or hearing disorders, serious articulation disorders and/or other deviations able to prevent the patient from adequate cooperation during the study)
- Mental disorders in the history
- Alcohol, drug abuse or drug dependence in the history
- Patients which, according to the investigator, are obviously or probably incapable of understanding and evaluating this study information within the process of the informed consent form signing, including but not limited to with regard to expected risks and possible discomfort
- Other diseases, symptoms or conditions not listed above, which, according to the investigator, are predicaments for the participation in the clinical study
- Erroneous inclusion (inclusion and exclusion criteria violation).
- Investigator or Sponsor's decision to exclude the patient from the study because of clinically significant deviation from protocol/protocol violation.
- Serious adverse events or adverse events which do not meet the seriousness criteria and which if developed, according to the investigator, can make the patient's further participation in the study harmful for the patient's health or wellbeing.
- Any adverse event (there might be no connection with the study drug intake) requiring the observation, procedures and/or drug treatment not allowed by this study protocol.
- Patient's refusal to continue the participation in the study or his/her lack of discipline.
- Allergic reaction to the study drug intake, which require its discontinuation.
- Patient's wish to prematurely terminate the study for any reason.
- Loss of contact with the patient and his/her absence for the visit.
- Necessity to use a therapy prohibited by this protocol.
- Occurrence of pregnancy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Federal State Budgetary Research Institution "Research Centre of Neurology"
Moscow
OsteoVita LLC
Saint Petersburg
Saint Petersburg State Budgetary Healthcare Institution "Municipal Hospital No. 40 of Kurortny District"
Sestroretsk
Centre For Evidence-Based Medicine Llc
Yaroslavl
Medical Centre of Diagnostics and Prevention Plus LLC
Yaroslavl
State Budgetary Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Hospital for War Veterans - International Elderly People Centre 'Zdorovoe Dolgoletie'
Yaroslavl
About this study
Official title: 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)
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)
Read the 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.
- Being tested
- Ethyl methyl hydroxypyridine succinate + Meldonium, Placebo
- Medical subject headings
- Asthenia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl methyl hydroxypyridine succinate + MeldoniumDrug
Also called BRAINMAX®
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)
PlaceboDrug
Placebo was used in the same way
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ethyl methyl hydroxypyridine succinate + Meldonium |
| Placebo | Placebo comparator | Arm 2 (n=80) received Placebo in the same way. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to Visit 5 (day 41)
Secondary outcomes (18)
Asthenia on a scale MFI-20 after the completion of the parenteral therapy
Mean decrease of MFI-20 asthenia scale score after the completion of the parenteral therapy
Measured: From baseline to Visit 3 (day 11)
Asthenia on a scale MFI-20 after the completion of the oral therapy
Mean decrease of MFI-20 asthenia scale score after the completion of the oral therapy
Measured: From Visit 3 (day 11) to Visit 5 (day 41)
Headache on a visual analogue scale (VAS) after the completion of the sequential therapy
Score dynamics by VAS for the headache evaluation after the completion of the sequential therapy
Measured: From baseline to Visit 5 (day 41)
Headache on a VAS after the completion of the parenteral therapy
Score dynamics by VAS for the headache evaluation after the completion of the parenteral therapy
Measured: From baseline to Visit 3 (day 11)
Headache on a VAS after the completion of the oral therapy
Score dynamics by VAS for the headache evaluation after the completion of the oral therapy
Measured: From Visit 3 (day 11) to Visit 5 (day 41)
Sleep Quality on a Pittsburgh sleep quality index (PSQI) after the completion of the sequential therapy
Score dynamics by PSQI questionnaire after the completion of the sequential therapy
Measured: From baseline to Visit 5 (day 41)
Fatigue on a Fatigue Assessment Scale (FAS-10) scale after the completion of the sequential therapy
Score dynamics by FAS-10 scale after the completion of the sequential therapy
Measured: From baseline to Visit 5 (day 41)
Fatigue on a FAS-10 scale after the completion of the parenteral therapy
Score dynamics by FAS-10 scale after the completion of the parenteral therapy
Measured: From baseline to Visit 3 (day 11)
Fatigue on a FAS-10 scale after the completion of the oral therapy
Score dynamics by FAS-10 scale after the completion of the oral therapy
Measured: From Visit 3 (day 11) to Visit 5 (day 41)
Dizziness on a Dizziness Handicap Inventory (DHI) questionnaire after the completion of the sequential therapy
Score dynamics by DHI questionnaire after the completion of the sequential therapy
Measured: From baseline to Visit 5 (day 41)
Dizziness on a DHI questionnaire after the completion of the parenteral therapy
Score dynamics by DHI questionnaire after the completion of the parenteral therapy
Measured: From baseline to Visit 3 (day 11)
Dizziness on a DHI questionnaire after the completion of the oral therapy
Score dynamics by DHI questionnaire after the completion of the oral therapy
Measured: From Visit 3 (day 11) to Visit 5 (day 41)
Cognitive function on a Monreal Gognitive Assessment (MoCA) scale after the completion of the sequential therapy
Score dynamics by MoCA scale after the completion of the sequential therapy
Measured: From baseline to Visit 5 (day 41)
Anxiety on a Beck scale after the completion of the sequential therapy
Score dynamics by Beck scale after the completion of the sequential therapy
Measured: From baseline to Visit 5 (day 41)
Anxiety on a Beck scale after the completion of the parenteral therapy
Score dynamics by Beck scale after the completion of the parenteral therapy
Measured: From baseline to Visit 3 (day 11)
Anxiety on a Beck scale after the completion of the oral therapy
Score dynamics by Beck scale after the completion of the oral therapy
Measured: From Visit 3 (day 11) to Visit 5 (day 41)
Regulatory function on a Kerdo vegetation index after the completion of the sequential therapy
Changes in values of Kerdo vegetation index after the completion of the sequential therapy
Measured: From baseline to Visit 5 (day 41)
Regulatory function on a Kerdo vegetation index after the completion of the parenteral therapy
Changes in values of Kerdo vegetation index after the completion of the parenteral therapy
Measured: From baseline to Visit 3 (day 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start5 Apr 2022
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AstheniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promomed, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689827
- Sponsor's protocol ID
- BRAINMAX_ 2021
- Status last verified
- Jul 2023
- First submitted
- 18 Jan 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37167167
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05689827
- Acronym / sponsor ID
- BRAINMAX_ 2021
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Promomed, LLCUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethyl methyl hydroxypyridine succinate + Meldonium | Experimental | Drug: Ethyl methyl hydroxypyridine succinate + MeldoniumArm 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. |
| Placebo | Placebo comparator | Drug: PlaceboArm 2 (n=80) received Placebo in the same way. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethyl methyl hydroxypyridine succinate + MeldoniumAlso: BRAINMAX®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) | Drug | Ethyl methyl hydroxypyridine succinate + Meldonium |
| PlaceboPlacebo was used in the same way | Drug | Placebo |
Primary outcome
Asthenia on a scale Multidimensional Fatigue Inventory (MFI-20) after the completion of the sequential therapy
Time frame: From baseline to Visit 5 (day 41)
Mean decrease of MFI-20 asthenia scale score after the completion of the sequential therapy
18 secondary outcomes
Asthenia on a scale MFI-20 after the completion of the parenteral therapy
Time frame: From baseline to Visit 3 (day 11)
Asthenia on a scale MFI-20 after the completion of the oral therapy
Time frame: From Visit 3 (day 11) to Visit 5 (day 41)
Headache on a visual analogue scale (VAS) after the completion of the sequential therapy
Time frame: From baseline to Visit 5 (day 41)
Headache on a VAS after the completion of the parenteral therapy
Time frame: From baseline to Visit 3 (day 11)
Headache on a VAS after the completion of the oral therapy
Time frame: From Visit 3 (day 11) to Visit 5 (day 41)
Sleep Quality on a Pittsburgh sleep quality index (PSQI) after the completion of the sequential therapy
Time frame: From baseline to Visit 5 (day 41)
Fatigue on a Fatigue Assessment Scale (FAS-10) scale after the completion of the sequential therapy
Time frame: From baseline to Visit 5 (day 41)
Fatigue on a FAS-10 scale after the completion of the parenteral therapy
Time frame: From baseline to Visit 3 (day 11)
Fatigue on a FAS-10 scale after the completion of the oral therapy
Time frame: From Visit 3 (day 11) to Visit 5 (day 41)
Dizziness on a Dizziness Handicap Inventory (DHI) questionnaire after the completion of the sequential therapy
Time frame: From baseline to Visit 5 (day 41)
Dizziness on a DHI questionnaire after the completion of the parenteral therapy
Time frame: From baseline to Visit 3 (day 11)
Dizziness on a DHI questionnaire after the completion of the oral therapy
Time frame: From Visit 3 (day 11) to Visit 5 (day 41)
Cognitive function on a Monreal Gognitive Assessment (MoCA) scale after the completion of the sequential therapy
Time frame: From baseline to Visit 5 (day 41)
Anxiety on a Beck scale after the completion of the sequential therapy
Time frame: From baseline to Visit 5 (day 41)
Anxiety on a Beck scale after the completion of the parenteral therapy
Time frame: From baseline to Visit 3 (day 11)
Anxiety on a Beck scale after the completion of the oral therapy
Time frame: From Visit 3 (day 11) to Visit 5 (day 41)
Regulatory function on a Kerdo vegetation index after the completion of the sequential therapy
Time frame: From baseline to Visit 5 (day 41)
Regulatory function on a Kerdo vegetation index after the completion of the parenteral therapy
Time frame: From baseline to Visit 3 (day 11)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 37167167Tanashyan 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.
- Cyberleninka is an open access scientific electronic libraryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ethyl methyl hydroxypyridine succinate + Meldonium in people with Asthenia and COVID-19, run by Promomed, LLC at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthenia on a scale Multidimensional Fatigue Inventory (MFI-20) after the completion of the sequential therapy (time frame: From baseline to Visit 5 (day 41)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.