Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma
NCT ID: NCT04468009
Last Updated: 2021-08-25
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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COMPLETED
PHASE2
134 participants
INTERVENTIONAL
2020-06-25
2021-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Standard of care
Standard of care for Covid-19
No interventions assigned to this group
PCC-19
Treatment with convalescent plasma
Convalescent plasma
Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies
Interventions
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Convalescent plasma
Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies
Eligibility Criteria
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Inclusion Criteria
* Patient with Covid-19 confirmed with nuclear acid testing
* Critically ill patients with Covid-19 on mechanical ventilation. Potencially critically ill patients (with acute respiratory distress syndrome, septic shock and/or multiple organ failure) with Covid-19.
* Diagnosed with acute respiratory distress syndrome.
* Informed consent.
Exclusion Criteria
* Symptoms for a period longer than 20 days.
* Not detectable by acid nuclear testing within 48 hours prior to elegibility.
* Descompensated congestive heart failure, in which receiving 500ml of intrasvascular volume signifies a life risk.
* History of severe adverse events or anaphylaxis to plasma components
18 Years
100 Years
ALL
Yes
Sponsors
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Hospital de Infecciosas Francisco Javier Muniz
OTHER_GOV
Responsible Party
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Carlos Alberto Gonzalez
Blood Bank Director in Hospital de Infecciosas Francisco Javier Muniz
Principal Investigators
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Carlos A Gonzalez, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Infecciosas Francisco Javier Muniz
Locations
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Hospital Francisco Javier Muñiz
Ciudad Autonoma de Buenos Aire, , Argentina
Countries
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References
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Enria DA, Briggiler AM, Fernandez NJ, Levis SC, Maiztegui JI. Importance of dose of neutralising antibodies in treatment of Argentine haemorrhagic fever with immune plasma. Lancet. 1984 Aug 4;2(8397):255-6. doi: 10.1016/s0140-6736(84)90299-x.
Rojas M, Rodriguez Y, Monsalve DM, Acosta-Ampudia Y, Camacho B, Gallo JE, Rojas-Villarraga A, Ramirez-Santana C, Diaz-Coronado JC, Manrique R, Mantilla RD, Shoenfeld Y, Anaya JM. Convalescent plasma in Covid-19: Possible mechanisms of action. Autoimmun Rev. 2020 Jul;19(7):102554. doi: 10.1016/j.autrev.2020.102554. Epub 2020 May 5.
Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
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.
Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Jul;158(1):e9-e13. doi: 10.1016/j.chest.2020.03.039. Epub 2020 Mar 31.
Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.
Ye M, Fu D, Ren Y, Wang F, Wang D, Zhang F, Xia X, Lv T. Treatment with convalescent plasma for COVID-19 patients in Wuhan, China. J Med Virol. 2020 Oct;92(10):1890-1901. doi: 10.1002/jmv.25882. Epub 2020 Jun 29.
Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.
Joyner M, Wright RS, Fairweather D, Senefeld J, Bruno K, Klassen S, Carter R, Klompas A, Wiggins C, Shepherd JR, Rea R, Whelan E, Clayburn A, Spiegel M, Johnson P, Lesser E, Baker S, Larson K, Ripoll Sanz J, Andersen K, Hodge D, Kunze K, Buras M, Vogt M, Herasevich V, Dennis J, Regimbal R, Bauer P, Blair J, van Buskirk C, Winters J, Stubbs J, Paneth N, Casadevall A. Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients. medRxiv [Preprint]. 2020 May 14:2020.05.12.20099879. doi: 10.1101/2020.05.12.20099879.
Valk SJ, Piechotta V, Chai KL, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review. Cochrane Database Syst Rev. 2020 May 14;5(5):CD013600. doi: 10.1002/14651858.CD013600.
Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.
To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: passive immunotherapy for influenza and other serious infections. Crit Care Med. 2010 Apr;38(4 Suppl):e66-73. doi: 10.1097/CCM.0b013e3181d44c1e.
Wong VW, Dai D, Wu AK, Sung JJ. Treatment of severe acute respiratory syndrome with convalescent plasma. Hong Kong Med J. 2003 Jun;9(3):199-201.
Kong LK, Zhou BP. Successful treatment of avian influenza with convalescent plasma. Hong Kong Med J. 2006 Dec;12(6):489. No abstract available.
Leider JP, Brunker PA, Ness PM. Convalescent transfusion for pandemic influenza: preparing blood banks for a new plasma product? Transfusion. 2010 Jun;50(6):1384-98. doi: 10.1111/j.1537-2995.2010.02590.x. Epub 2010 Feb 11.
Zhou B, Zhong N, Guan Y. Treatment with convalescent plasma for influenza A (H5N1) infection. N Engl J Med. 2007 Oct 4;357(14):1450-1. doi: 10.1056/NEJMc070359. No abstract available.
Wong HK, Lee CK, Hung IF, Leung JN, Hong J, Yuen KY, Lin CK. Practical limitations of convalescent plasma collection: a case scenario in pandemic preparation for influenza A (H1N1) infection. Transfusion. 2010 Sep;50(9):1967-71. doi: 10.1111/j.1537-2995.2010.02651.x.
Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.
Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
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Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.
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Toy P. Update on transfusion-related acute lung injury. Clin Adv Hematol Oncol. 2019 Jul;17(7):378-381. No abstract available.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1725
Identifier Type: -
Identifier Source: org_study_id
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