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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
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)
Placebo was used in the same way
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
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
Time frame: From baseline to Visit 5 (day 41)
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
Time frame: 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
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
Score dynamics by VAS for the headache evaluation 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
Score dynamics by VAS for the headache evaluation 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
Score dynamics by VAS for the headache evaluation 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
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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
Score dynamics by PSQI questionnaire 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
Score dynamics by 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
Score dynamics by 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
Score dynamics by 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
Score dynamics by 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
Score dynamics by 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
Score dynamics by 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
Score dynamics by 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
Score dynamics by 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
Score dynamics by 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
Score dynamics by 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
Changes in values of 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
Changes in values of Kerdo vegetation index after the completion of the parenteral therapy
Time frame: From baseline to Visit 3 (day 11)