Therapy of asthenia in patients after acute novel coronavirus infection (COVID-19): results of a multicenter, randomized, double-blind, placebocontrolled clinical study

  • Authors: Ostroumova O.D.1, Ebzeeva E.Y.1, Polyakova O.A.1, Gantseva K.K.2, Malchikova S.V.3, Ershov O.B.4,5, Kamchatnov P.R.6, Avdeeva M.G.7, Filippov E.V.8, Ushakova S.E.9, Khamitov R.F.10, Beloglazov V.A.11, Pyankov A.F.12, Grigorovich M.S.3, Ezhov A.V.13
  • Affiliations:
    1. Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia
    2. Bashkir State Medical University of the Ministry of Healthcare of Russia
    3. Kirov State Medical University of the Ministry of Healthcare of Russia
    4. Center for Medical Consultations and Research - PRACTICA LLC
    5. Yaroslavl State Medical University of the Ministry of Healthcare of Russia
    6. N.I. Pirogov Russian National Research Medical University of the Ministry of Healthcare of Russia
    7. Kuban State Medical University of the Ministry of Healthcare of Russia
    8. Academician I.P. Pavlov Ryazan State Medical University of the Ministry of Healthcare of Russia
    9. Ivanovo State Medical Academy of the Ministry of Healthcare of Russia
    10. Kazan State Medical University of the Ministry of Healthcare of Russia
    11. Medical Academy named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University of the Ministry of Science and Higher Education of the Russia
    12. I.M. Sechenov Academic Research Institute of Physical Methods of Treatment, Medical Climatology and Rehabilitation
    13. City Clinical Hospital No. 9 of the Ministry of Healthcare of the Udmurt Republic
  • Issue: Vol 8, No 8 (2022)
  • Pages: 146-157
  • Section: Articles
  • URL: https://journals.eco-vector.com/2412-4036/article/view/276911
  • DOI: https://doi.org/10.18565/therapy.2022.8.146-157
  • ID: 276911

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Abstract

Fatigue or asthenia is the most common symptom after acute new-onset coronavirus infection (COVID-19), leading to long-term impairment of working ability. The aim of this multicenter, double-blind, placebo-controlled, randomized clinical trial was to evaluate the efficacy and safety of Prospekta medicine in post-COVID-19 asthenia treatment. Material and methods. A total of 676 patients were enrolled in a double-blind, placebo-controlled, randomised, parallel-group clinical trial. The mean age of Prospekta group patients was 44,3±12,5 years. Patients of both sexes, aged 18 years to 65 years inclusive, between 4 and 12 weeks of confirmed acute infection COVID-19, with symptoms of asthenia occurring during or after COVID-19, persisting from 4 to 12 weeks after onset, were included in the study. The presence of asthenia was indicated by FSS score s36. After signing information consent, patients also completed HADS scale followed by the 6-minute walk test (6MW) to assess the possible duration of walking. After randomization, patients in group 1 received Prospekta, 1 tablet 2 times daily for 4 weeks; patients in group 2 received placebo according to the study drug regimen. Results. Patients in both groups had no differences in demographic and baseline clinical characteristics. Patients in Prospekta group had a baseline FSS score of 46,4±6,9 for asthenia symptoms, and 45,9±6,6 for placebo group. Treatment with Prospekta for 4 weeks resulted in a clinically significant decrease of the mean FSS score from 46,4±6,9 to 29,9±9,2, in the placebo group from 45,9±6,6 to 31,9±9,9 (р=0,0016). By the end of 4 weeks of treatment in the Prospekta group, there was a tendency to lengthen the distance walked in the 6MW by 31,4±44,5 m (in the Placebo group by 27,8±38,1 m); the difference between changes in the mean distance (6MW) during the study therapy was 3,62±41,35 m. The 4-week therapy with Prospekta also contributed to a reduction in anxiety/depression severity by decreasing the mean HADS anxiety/depression subscale score from 8,5±4,1 to 5,5±3,2 and from 8,1±3,7 to 4,7±2,9, respectively, in the Placebo group, from 8,8±3,9 to 6,0±3,3 and from 8,3±3,8 to 5,2±3,0, respectively. Conclusion. Prospekta is an effective and safe agent in the treatment of asthenia after acute infection COVID-19.

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About the authors

Olga D. Ostroumova

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia

Email: ostroumova.olga@mail.ru
Dr. med. habil., professor, head of the Department of therapy and polymorbid pathology named after Academician M.S. Vovsi

Elizaveta Yu. Ebzeeva

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia

Email: veta-veta67@mail.ru
PhD in Medicine, associate professor, associate professor of the Department of therapy and polymorbid pathology named after Academician M.S. Vovsi

Olga A. Polyakova

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia

Email: docpolyakova.olga@gmail.com
PhD in Medicine, assistant at the Department of therapy and polymorbid pathology named after Academician M.S. Vovsi

Khalida Kh. Gantseva

Bashkir State Medical University of the Ministry of Healthcare of Russia

Email: gantseva48@mail.ru
Dr. med. habil., professor of the Department of internal medicine

Svetlana V. Malchikova

Kirov State Medical University of the Ministry of Healthcare of Russia

Email: malchikova@list.ru
Dr. med. habil., professor of the Department of hospital therapy

Olga B. Ershov

Center for Medical Consultations and Research - PRACTICA LLC; Yaroslavl State Medical University of the Ministry of Healthcare of Russia

Email: ershova.olga-personal@mail.ru
Dr. med. habil., professor of the Department of therapy of the Institute of continuing professional education

Pavel R. Kamchatnov

N.I. Pirogov Russian National Research Medical University of the Ministry of Healthcare of Russia

Email: pavkam7@gmail.com
Dr. med. habil., professor of the Department of neurology and neurosurgery, faculty of medicine

Marina G. Avdeeva

Kuban State Medical University of the Ministry of Healthcare of Russia

Email: avdeevam@mail.ru
Dr. med. habil., professor, head of the Department of infectious diseases and phthisiopulmonology

Evgeny V. Filippov

Academician I.P. Pavlov Ryazan State Medical University of the Ministry of Healthcare of Russia

Email: dr.philippov@gmail.com
Dr. med. habil., professor, head of the Department of polyclinic therapy and preventive medicine

Svetlana E. Ushakova

Ivanovo State Medical Academy of the Ministry of Healthcare of Russia

Email: svetland1962@mail.ru
Dr. med. habil., associate professor, head of the Department of hospital therapy and endocrinology

Rustem F. Khamitov

Kazan State Medical University of the Ministry of Healthcare of Russia

Email: rhamitov@mail.ru
Dr. med. habil., professor, head of the Department of internal diseases

Vladimir A. Beloglazov

Medical Academy named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University of the Ministry of Science and Higher Education of the Russia

Email: biloglazov@mail.ru
Dr. med. habil., head of the Department of internal medicine No. 2 of the Medical Academy named after S.I. Georgievsky

Alexander F. Pyankov

I.M. Sechenov Academic Research Institute of Physical Methods of Treatment, Medical Climatology and Rehabilitation

Email: a_pyankov@hotmail.com
PhD in Medicine, associate professor, scientific secretary

Marina S. Grigorovich

Kirov State Medical University of the Ministry of Healthcare of Russia

Email: grigorovich-mari@mail.ru
Dr. med. habil., associate professor, head of the Department of family medicine and polyclinic therapy

Andrey V. Ezhov

City Clinical Hospital No. 9 of the Ministry of Healthcare of the Udmurt Republic

Email: andigel2@rambler.ru
Dr. med. habil., general practitioner

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