Asthenia, COVID-19
Conditions
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)
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.
Interventions
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)
DRUGPlacebo
Placebo was used in the same way
Sponsors
Promomed, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 11. Autoimmune diseases 12. Other chronical diseases which, according to the investigator, can cause asthenia 13. G lomerular filtration rate (GFR) parameter at screening \< 30 mL/min 14. Pregnancy or lactation period 15. Participation in any other clinical study during the last 3 months 16. Tuberculosis, cancers or positive reaction to the HIV infection, hepatitis B & C, syphilis according to the history data 17. Severe eyesight and/or hearing disorders, serious articulation disorders and/or other deviations able to prevent the patient from adequate cooperation during the study) 18. Mental disorders in the history 19. Alcohol, drug abuse or drug dependence in the history 20. 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 21. Other diseases, symptoms or conditions not listed above, which, according to the investigator, are predicaments for the participation in the clinical study Exclusion of patients from the study 1. Erroneous inclusion (inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthenia on a scale Multidimensional Fatigue Inventory (MFI-20) after the completion of the sequential therapy | From baseline to Visit 5 (day 41) | Mean decrease of MFI-20 asthenia scale score after the completion of the sequential therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthenia on a scale MFI-20 after the completion of the oral therapy | From Visit 3 (day 11) to Visit 5 (day 41) | Mean decrease of MFI-20 asthenia scale score after the completion of the oral therapy |
| Headache on a visual analogue scale (VAS) after the completion of the sequential therapy | From baseline to Visit 5 (day 41) | Score dynamics by VAS for the headache evaluation after the completion of the sequential therapy |
| Headache on a VAS after the completion of the parenteral therapy | From baseline to Visit 3 (day 11) | Score dynamics by VAS for the headache evaluation after the completion of the parenteral therapy |
| Headache on a VAS after the completion of the oral therapy | From Visit 3 (day 11) to Visit 5 (day 41) | Score dynamics by VAS for the headache evaluation after the completion of the oral therapy |
| Sleep Quality on a Pittsburgh sleep quality index (PSQI) after the completion of the sequential therapy | From baseline to Visit 5 (day 41) | Score dynamics by PSQI questionnaire after the completion of the sequential therapy |
| Fatigue on a Fatigue Assessment Scale (FAS-10) scale after the completion of the sequential therapy | From baseline to Visit 5 (day 41) | Score dynamics by FAS-10 scale after the completion of the sequential therapy |
| Fatigue on a FAS-10 scale after the completion of the parenteral therapy | From baseline to Visit 3 (day 11) | Score dynamics by FAS-10 scale after the completion of the parenteral therapy |
| Fatigue on a FAS-10 scale after the completion of the oral therapy | From Visit 3 (day 11) to Visit 5 (day 41) | Score dynamics by FAS-10 scale after the completion of the oral therapy |
| Asthenia on a scale MFI-20 after the completion of the parenteral therapy | From baseline to Visit 3 (day 11) | Mean decrease of MFI-20 asthenia scale score after the completion of the parenteral therapy |
| Dizziness on a DHI questionnaire after the completion of the parenteral therapy | From baseline to Visit 3 (day 11) | Score dynamics by DHI questionnaire after the completion of the parenteral therapy |
| Dizziness on a DHI questionnaire after the completion of the oral therapy | From Visit 3 (day 11) to Visit 5 (day 41) | Score dynamics by DHI questionnaire after the completion of the oral therapy |
| Cognitive function on a Monreal Gognitive Assessment (MoCA) scale after the completion of the sequential therapy | From baseline to Visit 5 (day 41) | Score dynamics by MoCA scale after the completion of the sequential therapy |
| Anxiety on a Beck scale after the completion of the sequential therapy | From baseline to Visit 5 (day 41) | Score dynamics by Beck scale after the completion of the sequential therapy |
| Anxiety on a Beck scale after the completion of the parenteral therapy | From baseline to Visit 3 (day 11) | Score dynamics by Beck scale after the completion of the parenteral therapy |
| Anxiety on a Beck scale after the completion of the oral therapy | From Visit 3 (day 11) to Visit 5 (day 41) | Score dynamics by Beck scale after the completion of the oral therapy |
| Regulatory function on a Kerdo vegetation index after the completion of the sequential therapy | From baseline to Visit 5 (day 41) | Changes in values of Kerdo vegetation index after the completion of the sequential therapy |
| Regulatory function on a Kerdo vegetation index after the completion of the parenteral therapy | From baseline to Visit 3 (day 11) | Changes in values of Kerdo vegetation index after the completion of the parenteral therapy |
| Dizziness on a Dizziness Handicap Inventory (DHI) questionnaire after the completion of the sequential therapy | From baseline to Visit 5 (day 41) | Score dynamics by DHI questionnaire after the completion of the sequential therapy |
Countries
Russia
Outcome results
None listed