Etiotropic Therapy of Mild COVID-19 in Outpatient Patients: Molnupiravir is in Focus

DOI: 10.47026/2413-4864-2023-3-1-15

UDC: 616-085:616-036.21
BBC: Р28

Balykova L.A., Pshenichnaya N.Yu., Omarova Kh.G., Pushkar D.Yu., Zaslavskaia K.Ya., Zemskov D.N., Taganov A.V., Belyi P.A., Gorelov A.V., Kozlov E.D., Shepeleva O.I., Prekina V.I., Semenova E.V.

Etiotropic Therapy of Mild COVID-19 in Outpatient Patients: Molnupiravir is in Focus

Keywords: COVID-19, SARS-CoV-2, etiotropic therapy, disease progression, Molnupiravir, virus elimination

The aim of the study was to evaluate the efficacy and tolerability of the drug Molnupiravir in adult outpatients with mild Covid–19. Materials and methods. A randomized comparative open clinical trial of Molnupiravir (800 mg twice daily for 5 days in addition to symptomatic/pathogenetic therapy) was conducted in confirmed COVID-19 in comparison with a standard therapy. 240 patients (average age – 43.5 years; 70% had risk factors) were randomized in a 1:1 ratio to the Molnupiravir group and the standard therapy group. Clinical efficacy was assessed based on the analysis of the patient's daily diary, physical examination data and SARS-CoV-2 RNA in the smear from the oropharynx and nasopharynx. The primary endpoint was the proportion of patients with the transition of COVID-19 course to a more severe degree relative to the initial state 2 weeks after the onset of the disease. Significance was assessed using a two-sided version of the Fisher Exact test. Results. Molnupiravir: a) reduced the risk of disease progression by 4 times by the 14^th –15^th day of follow-up, compared with the risk in the control group (2.5% and 10% of patients, respectively, p = 0.0149); b) accelerated virus elimination by the 6^th – 7^th day of follow-up (71.67% vs. 58.33%, respectively); c) accelerated clinical recovery (which by day 6-7 had 19% of patients in the Molnupiravir group, and 6% of patients on standard therapy); d) reduced the frequency and severity of COVID-19 symptoms: cough, ageusia. The incidence of adverse events in the study participants was comparable. Conclusions. Molnupiravir administration reduces the risk of COVID-19 progression to a severe course, reduces the severity of COVID-19 clinical manifestations, probably by accelerating the virus elimination. The data obtained indicate feasibility of using Molnupiravir for COVID-19 treatment on an outpatient basis.

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About authors

Balykova Larisa A.: Doctor of Medical Sciences, Professor, Corresponding Member of RAS, Director of the Medicine Institute, Head of the Pediatrics Department, National Research Ogarev Mordovia State University, Russia, Saransk (larisabalykova@yandex.ru; ORCID: https://orcid.org/0000-0002-2290-0013)

Pshenichnaya Natalia Yu.: Doctor of Medical Sciences, Professor, Deputy Director for Clinical and Analytical Work, Central Research Institute of Epidemiology of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Russia, Moscow (natalia-pshenichnaya@yandex.ru; ORCID: https://orcid.org/0000-0003-2570-711X)

Omarova Khadizhat G.: Candidate of Medical Sciences, Head of the Clinical Research Department, Central Research Institute of Epidemiology of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Russia, Moscow (omarova@cmd.su; ORCID: https://orcid.org/0000-0002-9682-2230)

Pushkar Dmitrii Yu.: Academician of RAS, Doctor of Medical Sciences, Professor, Member of the Academic Consortium of the Academic Community for the Study of COVID-19, Chief Freelance Urologist of the Ministry of Health of the Russian Federation, Head of the Urology Department, A.I. Evdokimov Moscow University of Medicine and Dentistry, Russia, Moscow (pushkardm@mail.ru; ORCID: https://orcid.org/0000-0002-6096-5723)

Zaslavskaia Kira Ya.: Assistant Lecturer, Department of Biological and Pharmaceutical Chemistry with the Course of Organization and Management of Pharmacy, Institute of Medicine, National Research Ogarev Mordovia State University, Russia, Saransk (kiryonok@yandex.ru; ORCID: https://orcid.org/0000-0002-7348-9412)

Zemskov Dmitrii N.: Assistant Lecturer, Department of Pharmacology and Clinical Pharmacology with a Course in Pharmaceutical Technology, Institute of Medicine, National Research Ogarev Mordovia State University, Russia, Saransk (dizem1978@gmail.com; ORCID: https://orcid.org/0000-0002-0181-4327)

Taganov Aleksei V.: Doctor of Medical Sciences, Professor, Department of Dermatovenereology with a Course of Cosmetology, Faculty of Continuous Medical Education, Institute of Medicine, RUDN University, Russia, Moscow (matis87177@yandex.ru; ORCID: https://orcid.org/0000-0001-5056-374X)

Belyi Petr A.: Candidate of Medical Sciences, Senior Laboratory Assistant, Department of Propaedeutics of Internal Diseases and Gastroenterology, A.I. Evdokimov Moscow University of Medicine and Dentistry, Russia, Moscow (pbely@ncpharm.ru; ORCID: https://orcid.org/0000-0001-5998-4874)

Gorelov Aleksandr V.: Academician of RAS, Doctor of Medical Sciences, Professor, Deputy Director for Research, Central Research Institute of Epidemiology of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing; Professor, Department of Pediatric Diseases, I.M. Sechenov First Moscow State Medical University (Sechenovskiy University), Russia, Moscow (zdn@pcr.ru; ORCID: https://orcid.org/0000-0001-9257-0171)

Kozlov Evgenii D.: Senior Lecturer, Department of Outpatient Therapy, Institute of Medicine, National Research Ogarev Mordovia State University, Russia, Saransk (dr.kozlov@yandex.ru; ORCID: https://orcid.org/0000-0001-8373-6109)

Shepeleva Olga I.: Candidate of Medical Sciences, Associate Professor, Department of Hospital Therapy, Institute of Medicine, National Research Ogarev Mordovia State University, Russia, Saransk (shepeleva-oi@mail.ru; ORCID: https://orcid.org/0000-0001-8307-2787)

Prekina Valentina I.: Candidate of Medical Sciences, Associate Professor, Department of Outpatient Therapy, Institute of Medicine, National Research Ogarev Mordovia State University, Russia, Saransk (vprekina@mail.ru; ORCID: https://orcid.org/0000-0002-2306-722X)

Semenova Elena V.: Candidate of Medical Sciences, Associate Professor, Department of Pharmacology and Clinical Pharmacology with a Course in Pharmaceutical Technology, National Research Ogarev Mordovia State University, Russia, Saransk (yelenadan@mail.ru; ORCID: https://orcid.org/0000-0001-7671-7110)

Article link

Balykova L.A., Pshenichnaya N.Yu., Omarova Kh.G., Pushkar D.Yu., Zaslavskaia K.Ya., Zemskov D.N., Taganov A.V., Belyi P.A., Gorelov A.V., Kozlov E.D., Shepeleva O.I., Prekina V.I., Semenova E.V. Etiotropic Therapy of Mild COVID-19 in Outpatient Patients: Molnupiravir is in Focus [Electronic resource] // Acta medica Eurasica. – 2023. – №3. P. 1-15. – URL: https://acta-medica-eurasica.ru/en/single/2023/3/1/. DOI: 10.47026/2413-4864-2023-3-1-15.

Single article

Balykova L.A., Pshenichnaya N.Yu., Omarova Kh.G., Pushkar D.Yu., Zaslavskaia K.Ya., Zemskov D.N., Taganov A.V., Belyi P.A., Gorelov A.V., Kozlov E.D., Shepeleva O.I., Prekina V.I., Semenova E.V.