Safety and Efficacy of the Therapy With BREINMAX® for the Treatment of Patients With Asthenia After 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 BREINMAX®, solution for intravenous infusion and intramuscular injection, and BREINMAX®, capsules for the treatment of patients with asthenia after having the novel coronavirus infection (COVID-19)

Inclusion Criteria:Patients able to sign the patient informed consent form for the participation in the clinical studyPatients of both sexes of 18-65 years of agePatient's negative test result for severe acute respiratory syndrome (SARS) -CoV-2 RNA obtained by polymerase chain reaction (PCR) method within 72 hoursCOVID-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 diagnosisPatients capable of following the requirements of the Clinical Study ProtocolNegative pregnancy test result (for women with the active childbearing potential)MFI-20 scale score is more than 30 at the moment of screening.Exclusion Criteria:Allergic reactions to the components of the study productOxygen saturation by pulse oximetry (SpO2) oxygen saturation ≤ 95%Depression level score by Hamilton Depression Rating Scale (HDRS) at the screening ≥ 8Intracranial pressure rise (for the reason of venous outflow disorder and intracranial tumours)Severe hepatic failureSevere renal failureChronic liver and hepatic diseasesThyroid diseasesAnaemiaMalignant tumour of any localization currently or during 5 years before the inclusion into the study except for completely treated carcinoma in situAutoimmune diseasesOther chronical diseases which, according to the investigator, can cause astheniaG lomerular filtration rate (GFR) parameter at screening < 30 mL/minPregnancy or lactation periodParticipation in any other clinical study during the last 3 monthsTuberculosis, cancers or positive reaction to the HIV infection, hepatitis B & C, syphilis according to the history dataSevere 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 historyAlcohol, drug abuse or drug dependence in the historyPatients 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 discomfortOther diseases, symptoms or conditions not listed above, which, according to the investigator, are predicaments for the participation in the clinical studyExclusion of patients from the studyErroneous 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.