Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2020-04-14
2021-09-01
Brief Summary
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What is our study about? In light of recent promising data on plasma therapy in the treatment of COVID-19 and other viral epidemics, there is a need for better understanding the cytokine response to the virus in order to better characterize the target population for convalescent plasma therapy.
Our hypothesis is that convalescent plasma transfusion from healthy donors who recovered from SARS CoV-2 is able to reduce the cytokine storm in addition to replenish the patient's own antibodies in the acutely infected phase of the disease.
A plasmapheresis donation of 400ml will be performed in subjects who recovered from COVID-19 and who are otherwise eligible for plasma donation. The sample will be tested for anti-SARS CoV-2 neutralizing antibody titers and those that reach the level of 1:320 will be processed for transfusion at the Hungarian National Transfusion Service.
Recipients will be COVID-19 patients requiring hospitalization regardless of the severity of the disease or other co-morbidities. A blood-type matched transfusion of 200 ml convalescent plasma will be infused in a single sitting through an iv. infusion of 4 hours.
Recipients will be followed up at days 1, 3,7,12, 17, 28 for clinical symptoms, antibody levels and cytokine response.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hospitalized patients with SARS CoV-2 infection
anti-SARS-CoV-2 convalescent plasma
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~200 mL over 4 hours
Interventions
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anti-SARS-CoV-2 convalescent plasma
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~200 mL over 4 hours
Eligibility Criteria
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Inclusion Criteria
* body weight : \>50 kg
* confirmed previous SARS CoV-2 infection
* 2 negative SARS CoV-2 test result
* written informed consent
* neutralizing antibody titer min. 1 : 120
* age : \>18 years
* admitted to hospital due to SARS CoV-2 infection
* written informed consent
Exclusion Criteria
* female subjects who are pregnant
* HIV1,2 hepatitis B,C or syphilis infection
to minimize the transfusional side effects our aim is to include mostly male donors.
* age : \<18 years
* female subjects who are pregnant or breastfeeding
* patients with prior allergic reaction to transfusion
* patients who received in the past 30 days immunoglobulin therapy
18 Years
ALL
Yes
Sponsors
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Semmelweis University
OTHER
University of Pecs
OTHER
Hungarian National Blood Service
UNKNOWN
Humán Bioplazma Kft - Kedrion
UNKNOWN
Orthosera Kft.
OTHER
Responsible Party
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Principal Investigators
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Veronika Müller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University
Locations
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Semmelweis University's Department of Pulmonology
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Veronika Müller, MD
Role: primary
References
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Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
Belyakov IM, Hel Z, Kelsall B, Kuznetsov VA, Ahlers JD, Nacsa J, Watkins DI, Allen TM, Sette A, Altman J, Woodward R, Markham PD, Clements JD, Franchini G, Strober W, Berzofsky JA. Mucosal AIDS vaccine reduces disease and viral load in gut reservoir and blood after mucosal infection of macaques. Nat Med. 2001 Dec;7(12):1320-6. doi: 10.1038/nm1201-1320.
Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. 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. Epub 2020 Jan 24.
Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
Kardos D, Marschall B, Simon M, Hornyak I, Hinsenkamp A, Kuten O, Gyevnar Z, Erdelyi G, Bardos T, Paukovits TM, Magos K, Beres G, Szenthe K, Banati F, Szathmary S, Nehrer S, Lacza Z. Investigation of Cytokine Changes in Osteoarthritic Knee Joint Tissues in Response to Hyperacute Serum Treatment. Cells. 2019 Aug 3;8(8):824. doi: 10.3390/cells8080824.
Nacsa J, Edghill-Smith Y, Tsai WP, Venzon D, Tryniszewska E, Hryniewicz A, Moniuszko M, Kinter A, Smith KA, Franchini G. Contrasting effects of low-dose IL-2 on vaccine-boosted simian immunodeficiency virus (SIV)-specific CD4+ and CD8+ T cells in macaques chronically infected with SIVmac251. J Immunol. 2005 Feb 15;174(4):1913-21. doi: 10.4049/jimmunol.174.4.1913.
Related Links
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12\. Ethics of using convalescent whole blood and convalescent plasma during the Ebola epidemic. Interim guidance for ethics review committees, researchers, national health authorities and blood transfusion services. 2015 WHO/HIS/KER/GHE/15.1
Other Identifiers
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AntiCOVID19ORT
Identifier Type: -
Identifier Source: org_study_id
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