Safety and efficacy of convalescent plasma for COVID-19: the preliminary results of a clinical trial
- Authors: Baklaushev V.P.1, Averyanov A.V.1,2, Sotnikova A.G.1,2, Perkina A.S.1,2, Ivanov A.V.3, Yusubalieva G.M.1, Novikova O.N.1, Shikina V.E.1, Dupik N.V.1, Kedrova A.G.1, Sanzharov A.E.1, Shirshova E.V.1, Balionis O.I.1, Valuev-Elliston V.T.3, Zakirova N.F.1,3, Glazov Y.N.4, Panukhina I.A.1, Soloviev N.A.1, Vinokurov A.G.1, Ivanov Y.V.1, Vasilev V.N.1, Klypa T.V.1, Troitsky A.V.1
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Affiliations:
- Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
- Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia
- Engelhardt Institute of Molecular Biology of the Russian Academy of Sciences
- Blood Center of the Federal Medical and Biological Agency of Russia
- Issue: Vol 11, No 2 (2020)
- Pages: 38-50
- Section: Original Study Articles
- URL: https://journals.rcsi.science/clinpractice/article/view/35168
- DOI: https://doi.org/10.17816/clinpract35168
- ID: 35168
Cite item
Abstract
Background. The lack of effective etiotropic therapy for COVID-19 has prompted researchers around the globe to seekr various methods of SARS-CoV-2 elimination, including the use of convalescent plasma.
Aim. The aim of this work was to study the safety and efficacy of the convalescence plasma treatment of severe COVID-19 using the plasma containing specific antibodies to the receptor binding domain (RBD) of SARS-CoV-2 S protein in a titer of at least 1:1000.
Methods. A single-center, randomized, prospective clinical study was performed at the FRCC FMBA of Russia with the participation of 86 patients who were stratified in two groups. The first group included 20 critically ill patients who were on mechanical ventilation the second group included 66 patients with moderate to severe COVID-19 and with spontaneous respiration. The patients in the second group were randomized into two cohorts in a ratio of 2:1. In the first cohort (46 patients), pathogen-reduced convalescent plasma was transfused (twice, 320 ml each), in the second cohort (20 patients) a similar amount of non-immune freshly frozen plasma was transfused to the patients.
Results. The use of plasma of convalescents in patients with severe COVID-19 being on mechanical ventilation does not affect the disease outcome in these patients. The mortality rate in this group was 60%, which corresponds to the average mortality of COVID patients on mechanical ventilation in our hospital. In the second group, clinical improvement was detected in 75% and 51%, for convalescent and non-immune plasma, respectively. Of the 46 people who received convalescent plasma, three patients (6.5%) were transferred to mechanical ventilation, two of them died. In the group receiving non-immune plasma, the need for mechanical ventilation also arose in three patients (15%), of which two died. The hospital mortality in the group of convalescent plasma was 4.3%, which is significantly lower than the average COVID-19 hospital mortality at our Center (6.73%) and more than two times lower than the hospital mortality in the control group (n=150), matched by age and by the disease severity.
Conclusions. Thus, we demonstrated a relative safety of convalescent plasma transfusion and the effectiveness of such therapy for COVID-19 at least in terms of the survival of hospitalized patients with severe respiratory failure without mechanical ventilation. In the absence of bioengineered neutralizing antibodies and effective etiotropic therapy, the use of hyperimmune convalescent plasma is the simplest and most effective method of specific etiopathogenetic therapy of severe forms of COVID-19.
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##article.viewOnOriginalSite##About the authors
Vladimir P. Baklaushev
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Author for correspondence.
Email: baklaushev.vp@fnkc-fmba.ru
ORCID iD: 0000-0003-1039-4245
SPIN-code: 3968-2971
https://fnkc-fmba.ru/about/komanda-upravleniya/
MD, PhD, Chief Scientific Officer
Russian Federation, MoscowAlexander V. Averyanov
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia; Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia
Email: averyanovav@mail.ru
ORCID iD: 0000-0003-1031-6933
SPIN-code: 2229-7100
MD, PhD, Professor
Russian Federation, MoscowAnna G. Sotnikova
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia; Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia
Email: sotnikoffaa@gmail.com
ORCID iD: 0000-0003-1237-8134
MD, PhD
Russian Federation, MoscowAnastasia S. Perkina
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia; Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia
Email: anastasyaperkina@gmail.com
ORCID iD: 0000-0003-0351-1802
MD
Russian Federation, MoscowAlexander V. Ivanov
Engelhardt Institute of Molecular Biology of the Russian Academy of Sciences
Email: aivanov@yandex.ru
ORCID iD: 0000-0002-5659-9679
PhD
Russian Federation, MoscowGaukhar M. Yusubalieva
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: gaukhar@gaukhar.org
ORCID iD: 0000-0003-3056-4889
SPIN-code: 1559-5866
MD, PhD
Russian Federation, MoscowOksana N. Novikova
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: Novikova_oksana_@mail.ru
ORCID iD: 0000-0003-2779-0383
MD, PhD
Russian Federation, MoscowValentina E. Shikina
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: shik-val@mail.ru
ORCID iD: 0000-0002-6672-4269
MD, PhD
Russian Federation, MoscowNikolay V. Dupik
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: dnv-74@yandex.ru
ORCID iD: 0000-0002-6672-4269
MD
Russian Federation, MoscowAnna G. Kedrova
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: kedrova.anna@gmail.com
ORCID iD: 0000-0003-1031-9376
SPIN-code: 3184-9760
MD, PhD
Russian Federation, MoscowAndrey E. Sanzharov
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: sanzh@mail.ru
ORCID iD: 0000-0003-1056-3053
SPIN-code: 5713-5791
MD
Russian Federation, MoscowElena V. Shirshova
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: shirshova60@rambler.ru
ORCID iD: 0000-0001-9193-0534
MD, PhD
Russian Federation, MoscowOlga I. Balionis
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: balionis.oi@gmail.com
ORCID iD: 0000-0002-8251-4050
SPIN-code: 7208-4442
MD
Russian Federation, MoscowVladimir T. Valuev-Elliston
Engelhardt Institute of Molecular Biology of the Russian Academy of Sciences
Email: gansfaust@mail.ru
ORCID iD: 0000-0003-0365-570X
SPIN-code: 3492-4501
Russian Federation, Moscow
Natalia F. Zakirova
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia; Engelhardt Institute of Molecular Biology of the Russian Academy of Sciences
Email: nat_zakirova@mail.ru
ORCID iD: 0000-0001-9704-6977
SPIN-code: 8050-2592
PhD
Russian Federation, MoscowYaroslav N. Glazov
Blood Center of the Federal Medical and Biological Agency of Russia
Email: yglazov@bloodfmba.ru
ORCID iD: 0000-0001-7761-8093
MD
Russian Federation, MoscowIrina A. Panukhina
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: panyuirina@yandex.ru
ORCID iD: 0000-0002-8662-3457
MD
Russian Federation, MoscowNikolay A. Soloviev
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: my_docs@mail.ru
ORCID iD: 0000-0001-9760-289X
SPIN-code: 8024-7220
MD, PhD
Russian Federation, MoscowAlexei G. Vinokurov
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: avinok@yandex.ru
ORCID iD: 0000-0002-6672-4269
MD, PhD
Russian Federation, MoscowYu. V. Ivanov
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: ivanovkb83@yandex.ru
ORCID iD: 0000-0001-6209-4194
SPIN-code: 3240-4335
MD, PhD
Russian Federation, MoscowValentin N. Vasilev
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: vasilievvn@list.ru
ORCID iD: 0000-0002-2853-4528
MD
Russian Federation, MoscowTatyana V. Klypa
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: tvklypa@gmail.com
ORCID iD: 0000-0002-2732-967X
MD, PhD
Russian Federation, MoscowAlexander V. Troitsky
Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Technologies of the Federal Medical and Biological Agency of Russia
Email: drtroitskiy@gmail.com
ORCID iD: 0000-0003-2411-6043
MD, PhD, Professor
Russian Federation, MoscowReferences
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