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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Arm 2 (n=80) received Placebo in the same way. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to Visit 3 (day 11) |
| Asthenia on a scale MFI-20 after the completion of the oral therapy |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion of patients from the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Research Institution "Research Centre of Neurology" | Moscow | Russia | ||||
| OsteoVita LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37167167 | Background | 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. |
| Label | URL |
|---|---|
| Cyberleninka is an open access scientific electronic library | View source |
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| ID | Term |
|---|---|
| D001247 | Asthenia |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| C050147 | 3-(2,2,2-trimethylhydrazine)propionate |
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|
|
| Placebo | Drug | Placebo was used in the same way |
|
Mean decrease of MFI-20 asthenia scale score 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 | Score dynamics by VAS for the headache evaluation 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 | Score dynamics by VAS for the headache evaluation 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 | Score dynamics by VAS for the headache evaluation after the completion of the oral therapy | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From baseline to Visit 3 (day 11) |
| 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 |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |