GY48LS6

Сан-Диего
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Плазма от доноров-реконвалесцентов COVID-19 (COVID-19 Convalescent Plasma)
Международное непатентованное наименование Плазма от доноров-реконвалесцентов COVID-19 (COVID-19 Convalescent Plasma)
Торговое наименование -
Производитель, страна -
Лекарственная форма свежезамороженная патоген-редуцированная плазма от доноров-реконвалесцентов COVID-19
Механизм действия

Clinical trials are being conducted to evaluate the use of COVID-19 convalescent plasma to treat patients with severe or immediately life-threatening COVID-19 infections.

 

COVID-19 convalescent plasma is not intended for prevention of the infection.

 

  • To participate in these trials, investigators should submit requests to the FDA for investigational use under the traditional IND regulatory pathway.
  • In addition to clinical trials, licensed physicians may obtain COVID-19 convalescent plasma for an individual patient through the process of single patient eINDs.
Опыт использования

In a case series of 5 critically ill patients with confirmed COVID-19 and acute respiratory distress syndrome (ARDS), patients received convalescent plasma.

 

Treatment: 2 consecutive transfusions of 200 mL to 250 mL of convalescent plasma (total dose: 400 mL) with a SARS-CoV-2-specific antibody (IgG) titer greater than 1:1,000 on the same day it was obtained from the donor.

 

Patient criteria included:

  • Severe pneumonia with rapid progression and continuously high viral load despite antiviral treatment
  • PAO2/FIO2 less than 300
  • Mechanical ventilation

 

After plasma infusion, body temperature normalized within 3 days in 4 of 5 patients, Sequential Organ Failure Assess (SOFA) score decreased and PAO2/FIO2 increased within 12 days.

 

Viral loads decreased and became negative within 12 days after the transfusion with the SARS-CoV-2-specific ELISA and neutralizing antibody titers increased after the transfusion.

 

ARDS resolved in 4 patients by day 12 after the transfusion and 3 patients were weaned from mechanical ventilation within 2 weeks of treatment.

Публикации COVID-19

Правительство Москвы. Департамент Здравоохранения города Москвы. Приказ от 01.04.2020 №325. О внедрении технологии использования свежезамороженной плазмы от доноров-реконвалесцентов COVID-19.

 

Evan M. Bloch, Shmuel Shoham, et al. Deployment of convalescent plasma for the prevention and treatment of COVID-19. The Journal of Clinical Investigation. 2020 April 7. 

 

Libo Zhang, Rongrong Pang, et al. Anti-SARS-CoV-2 virus antibody levels in convalescent plasma of six donors who have recovered from COVID-19. DOI: 10.18632/aging.103102.

 

Shen C, Wang Z, Zhao F, et al. Treatment of 5 critically ill patients with COVID-19 with convalescent plasma. JAMA 2020 Mar 27. PMID: 32219428.

 

Kai Duan, Bende Liu, et al. The feasibility of convalescent plasma therapy in severe COVID-19 patients: a pilot study. Posted March 23, 2020. doi: https://doi.org/10.1101/2020.03.16.20036145.

 

Kai Duan, Bende Liu, et al. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. PNAS. March 18, 2020. DOI: 10.1073/pnas.2004168117.

 

Mehta P, McAuley DF et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 16. pii: S0140-6736(20)30628-0. doi: 10.1016/S0140-6736(20)30628-0. 

 

Huang C, Wang Y et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. 

 

Kardos D, Marschall B, et al. Investigation of Cytokine Changes in Osteoarthritic Knee Joint Tissues in Response to Hyperacute Serum Treatment. Cells. 2019 Aug 3;8(8). pii: E824. doi: 10.3390/cells8080824.

 

Arabi Y, Balkhy H, Hajeer AH, et al. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015;4:709.

Клинические исследования
1.
Название протокола An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
Дата начала и окончания КИ May 1, 2020 - May 1, 2023
Название организации, проводящей КИ Medical College of Wisconsin
Страны USA
Фаза II
Кол-во пациентов 131
2.
Название протокола Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19
Дата начала и окончания КИ May 1, 2020 - January 2023
Название организации, проводящей КИ Johns Hopkins University
Страны USA
Фаза II
Кол-во пациентов 150
3.
Название протокола Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multi-stage, 6-armed Placebo-controlled Trial in the Framework of an Adaptive Trial Platform
Дата начала и окончания КИ April 20, 2020 - June 15, 2021
Название организации, проводящей КИ Hvidovre University Hospital
Страны Denmark
Фаза III
Кол-во пациентов 1500
4.
Название протокола A Pilot Study for Collection of Anti-SARS-CoV-2 Immune Plasma
Дата начала и окончания КИ April 15, 2020 - April 1, 2025
Название организации, проводящей КИ National Institutes of Health Clinical Center
Страны USA
Фаза -
Кол-во пациентов 2800
5.
Название протокола Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
Дата начала и окончания КИ April 15, 2020 - April 30, 2021
Название организации, проводящей КИ Hospital San Jose Tec de Monterrey
Страны Mexico
Фаза I
Кол-во пациентов 20
6.
Название протокола Anti COVID-19 Convalescent Plasma Therapy
Дата начала и окончания КИ April 14, 2020 - April 1, 2021
Название организации, проводящей КИ Orthosera Kft.
Страны Hungary
Фаза I
Кол-во пациентов 20
7.
Название протокола Convalescent Plasma in the Treatment of COVID 19
Дата начала и окончания КИ April 10, 2020 - April 1, 2021
Название организации, проводящей КИ Saint Francis Care
Страны USA
Фаза II
Кол-во пациентов 15
8.
Название протокола Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center
Дата начала и окончания КИ April 10, 2020 - December 31, 2021
Название организации, проводящей КИ University of Chicago
Страны USA
Фаза I
Кол-во пациентов 10
9.
Название протокола Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection
Дата начала и окончания КИ April 8, 2020 - August 31, 2021
Название организации, проводящей КИ Stony Brook University
Страны USA
Фаза I-II
Кол-во пациентов 500
10.
Название протокола Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients
Дата начала и окончания КИ April 3, 2020 - July 2020
Название организации, проводящей КИ Puerta de Hierro University Hospital
Страны Spain
Фаза II
Кол-во пациентов 278
11.
Название протокола Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19
Дата начала и окончания КИ April 1, 2020 - December 31, 2022
Название организации, проводящей КИ Baylor Research Institute
Страны USA
Фаза I
Кол-во пациентов 115
12.
Название протокола Convalescent Plasma for Patients With COVID-19: A Randomized, Open Label, Parallel, Controlled Clinical Study
Дата начала и окончания КИ April 1, 2020 - December 31, 2020
Название организации, проводящей КИ Universidad del Rosario
Страны Colombia
Фаза II-III
Кол-во пациентов 80
13.
Название протокола Convalescent Plasma for Patients With COVID-19: A Pilot Study
Дата начала и окончания КИ April 1, 2020 - December 31, 2020
Название организации, проводящей КИ Universidad del Rosario
Страны Colombia
Фаза II
Кол-во пациентов 10
14.
Название протокола Convalescent Plasma Therapy From Recovered Covid-19 Patients as Therapy for Hospitalized Patients With Covid-19
Дата начала и окончания КИ April 1, 2020 - July 1, 2020
Название организации, проводящей КИ Erasmus Medical Center
Страны Netherlands
Фаза II-III
Кол-во пациентов 426
15.
Название протокола Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection
Дата начала и окончания КИ April 2020 - April 2021
Название организации, проводящей КИ Hackensack Meridian Health
Страны USA
Фаза IIa
Кол-во пациентов 55
16.
Название протокола Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
Дата начала и окончания КИ March 28, 2020 - September 30, 2020
Название организации, проводящей КИ Mazandaran University of Medical Sciences
Страны Iran
Фаза -
Кол-во пациентов 30
17.
Название протокола The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study
Дата начала и окончания КИ February 1, 2020 - December 31, 2020
Название организации, проводящей КИ Shanghai Public Health Clinical Center
Страны China
Фаза -
Кол-во пациентов 15