Efficacy and safety of original drug based on hexapeptide succinate in complex COVID-19 therapy in adults hospitalized patients

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Currently, there are data that that make it possible to speak about a high clinical efficacy of the use of succinic salt of tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine (hexapeptide succinate) for the COVID-19 treatment. This article is devoted to the results of clinical trials of the original Russian drug based on it.

The aim of the study was to evaluate a clinical efficacy, safety and tolerability of intramuscular and inhalation use of hexapeptide succinate in complex therapy in comparison with standard therapy in patients with moderate COVID-19.

Materials and methods. The research was conducted from February 28, 2022 to November 22, 2022 based on 10 research centers in the Russian Federation. The study included hospitalized patients (n=312) over 18 years of age with moderate COVID-19 who had undergone a screening procedure and were randomized into 3 groups: group 1 received standard therapy in accordance with the Interim Guidelines in force at the time of the study, within 10 days; group 2 received hexapeptide succinate (Ambervin® Pulmo) intramuscularly at the dose of 1 mg once a day for 10 days; group 3 received hexapeptide succinate (Ambervin® Pulmo) 10 mg once a day by inhalation for 10 days.

Results. According to the results of the study, therapy with the drug hexapeptide succinate, both intramuscular and inhaled, provided an acceleration of recovery up to the complete absence of the disease signs in more than 80% of hospitalized COVID-19 patients. By the end of the therapy course with the drug, more than 60% of patients had met the criteria for discharge from hospital and could continue the treatment on an outpatient basis. About 70% of patients in the inhalation group and 80% in the intramuscular hexapeptide succinate injection group had concomitant diseases (hypertension – 28%, obesity – 14%), which indicates the effectiveness of this drug use in comorbid patients. The use of the drug contributed to the restoration of damaged lung tissues, normalization of oxygenation, the disappearance of shortness of breath and a decrease in the duration of the disease symptoms compared with standard therapy. As a result of a comparative analysis of adverse events in terms of their presence, severity, causal relationship with the therapy and outcome, there were no statistically significant differences between the treatment groups.

Conclusion. Thus, the results of the clinical study of the succinate hexapeptide efficacy and safety showed the feasibility of using the drug in pathogenetic therapy COVID-19 regimens.

作者简介

Larisa Balykova

National Research Ogarev Mordovia State University

Email: larisabalykova@yandex.ru
ORCID iD: 0000-0002-2290-0013

Doctor of Sciences (Medicine), Professor, Corresponding Member of the Russian Academy of Sciences, Head of the Department of Pediatrics, Director

俄罗斯联邦, 68, Bol’shevistskaya Str., Saransk, Republic of Mordovia, 430005

Olga Radaeva

National Research Ogarev Mordovia State University

Email: radaevamed@mail.ru
ORCID iD: 0000-0003-1383-2474

Doctor of Sciences (Medicine), Associate Professor, Head of the Department of Immunology, Microbiology and Virology with a Course of Clinical Immunology and Allergology

俄罗斯联邦, 68, Bol’shevistskaya Str., Saransk, Republic of Mordovia, 430005

Kira Zaslavskaya

National Research Ogarev Mordovia State University

编辑信件的主要联系方式.
Email: kiryonok@yandex.ru
ORCID iD: 0000-0002-7348-9412

Assistant of the Department of Biological and Pharmaceutical Chemistry with a Course of Organization and Management of Pharmacy

俄罗斯联邦, 68, Bol’shevistskaya Str., Saransk, Republic of Mordovia, 430005

Petr Bely

Moscow State Medical and Dental University named after A.I. Evdokimov

Email: pbely@ncpharm.ru
ORCID iD: 0000-0001-5998-4874

Candidate of Sciences (Medicine), Senior Laboratory Assistant, Department of Propaedeutics of Internal Diseases and Gastroenterology

俄罗斯联邦, Bld. 1, 20, Delegatskaya Str., Moscow, 127473

Vera Pavelkina

National Research Ogarev Mordovia State University

Email: pavelkina@rambler.ru
ORCID iD: 0000-0001-9582-9986

Doctor of Sciences (Medicine), Professor, Head of the Department of Infectious Diseases with courses in Epidemiology, Phthisiology, Skin and Venereal Diseases

俄罗斯联邦, 68, Bol’shevistskaya Str., Saransk, Republic of Mordovia, 430005

Nikolai Pyataev

National Research Ogarev Mordovia State University

Email: pyataevna@mail.ru
ORCID iD: 0000-0002-9688-7640

Doctor of Sciences (Medicine), Associate Professor, Head of the Department of Anesthesiology and Resuscitation

俄罗斯联邦, 68, Bol’shevistskaya Str., Saransk, Republic of Mordovia, 430005

Anastasia Ivanova

Regional Clinical Hospital; Ryazan State Medical University named after academician I.P. Pavlov

Email: Nastya_doctor@list.ru
ORCID iD: 0000-0002-4112-5382

Сardiologist, Ryazan State Medical University n. a. аcademician I.P. Pavlov; anesthesiologist-resuscitator, cardiologist of Regional Clinical Hospital, Ryazan

俄罗斯联邦, Bld. A, 3, Internatsionalnaya Str., Ryazan, 390039; 9, Vysokovoltnaya Str., Ryazan, 390026

Grigory Rodoman

Municipal clinical hospital No. 24, Moscow City Health Department

Email: generalsurgery24@mail.ru
ORCID iD: 0000-0001-6692-1425

Doctor of Sciences (Medicine), Chief Physician

俄罗斯联邦, 10, Pistsovaya Str., Moscow, 127015

Natalya Kostina

Voronezh Regional Clinical Hospital No. 1

Email: nata166k@yahoo.com
ORCID iD: 0000-0002-5128-5005

Head of the Department of Pulmonology

俄罗斯联邦, 151, Moskovsky Ave., Voronezh, 394066

Viktor Filimonov

Ryazan State Medical University named after academician I.P. Pavlov

Email: filimonov1974@mail.ru
ORCID iD: 0000-0002-2199-0715

Doctor of Sciences (Medicine), Professor, Head of the Department of Urology with a Course of Surgical Diseases

俄罗斯联邦, 9, Vysokovoltnaya Str., Ryazan, 390026

Elena Simakina

Smolensk Clinical Hospital No. 1

Email: e.simakina@mail.ru
ORCID iD: 0000-0002-5709-8913

Infectious Disease Specialist, Head of the Infectious Diseases Department

俄罗斯联邦, 40, Frunze Str., Smolensk, 214006

Dmitry Bystritsky

Infectious Clinical Hospital No. 1, Moscow City Health Department

Email: bistritskiyda@ikb1.ru
ORCID iD: 0000-0001-9253-9684

Specialist of the Organizational and Methodological Department of the Moscow Department of Health for infectious diseases, infectious diseases doctor, methodologist, Head of the department for the Provision of Paid Medical Services

俄罗斯联邦, 63, Volokolamsk Hwy, Moscow, 125367

Alina Agafyina

City Hospital No. 40, Kurortny District

Email: a.agafina@mail.ru
ORCID iD: 0000-0003-2598-4440

Candidate of Sciences (Medicine), Head of the Department of Clinical Research

俄罗斯联邦, 9B, Borisov Str., Sestroretsk, St. Petersburg, 197706

Ksenia Koryanova

Pyatigorsk Medical and Pharmaceutical Institute – branch of Volgograd State Medical University

Email: kskor-16@mail.ru
ORCID iD: 0000-0003-1571-9301

Candidate of Sciences (Pharmacy), Associate Professor of the Department of Pharmacology with a Course of Clinical Pharmacology

俄罗斯联邦, 11, Kalinin Ave., Pyatigorsk, 357532

Dmitry Pushkar

Moscow State Medical and Dental University named after A.I. Evdokimov; City Clinical Hospital named after S.I. Spasokukotsky, Moscow City Health Department

Email: pushkardm@mail.ru
ORCID iD: 0000-0002-6096-5723

Doctor of Sciences (Medicine), Professor, Head of the Department of Urology, Evdokimov Moscow State Medical and Dental University; urologist, City Clinical Hospital named after S.I. Spasokukotsky, Moscow City Health Department; Academician of the Russian Academy of Sciences

俄罗斯联邦, Bld. 1, 20, Delegatskaya Str., Moscow, 127473; 21, Vuchetich Str., Moscow, Russia, 127206

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版权所有 © Balykova L., Radaeva O., Zaslavskaya K., Bely P., Pavelkina V., Pyataev N., Ivanova A., Rodoman G., Kostina N., Filimonov V., Simakina E., Bystritsky D., Agafyina A., Koryanova K., Pushkar D., 2023

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