Controlled trials needed to prove efficacy and safety of convalescent plasma therapy in coronavirus disease 2019.
Controlled trials needed to prove efficacy and safety of convalescent plasma therapy in coronavirus disease 2019.
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DOI：
10.1016/j.anai.2020.11.005
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发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Rajasekaran S
中科院分区：
文献类型：
--
作者：
Hartog N;Holsworth A;Rajasekaran S
The novel coronavirus disease 2019 (COVID-19) emerged from Wuhan, People’s Republic of China, in December 2019, and by March 2020, it was recognized as a global pandemic by the World Health Organization. The speed with which the disease has spread and its sizable case fatality have led to the clinical application of various therapies with at most minimal evidence of efficacy or safety. This is of renewed and persistent importance as the number of polymerase chain reactionepositive cases of COVID-19 continues to increase in much of the United States of America. Use of convalescent plasma therapy for COVID-19 was initially reported in 5 patients in the People’s Republic of China. Its use has grown rapidly to become a mainstay of COVID-19 therapy owing to the United States Food and Drug Administration (FDA) expanded access and single-arm expanded access coordinated through the Mayo Clinic with greater than 105,000 patients being treated before the program closure owing to the FDA approving emergency use authorization (EUA). As the pandemic continues, the efficacy of convalescent plasma therapy remains to be established and has been unconvincing at best in its previous use in Ebola, influenza, severe acute respiratory syndromeeassociated coronavirus 1, or Middle East respiratory syndrome coronaviral infections. 1 Thus far, no placebo-controlled randomized controlled trial has revealed the efficacy of convalescent plasma in COVID-19. Despite this lack of evidence from a clinical trial, the FDA recently issued an EUA for convalescent plasma in COVID-19. In the past 2 decades, the use of blood products in critically ill patients has been discouraged by multiple societies and guidelines owing to inferior outcomes. The risks of convalescent plasma therapy include but are not limited to transfusion-associated circulatory overload, transfusion-related acute lung injury, complement-mediated tissue damage, allergic reactions, and antibody-dependent enhancement of disease. 2 The very nature of transfusion-mediated injuries dictates that an “inflammatory first hit” be present, thus laying the foundation for virus-related pulmonary manifestations to serve that role. Therefore, the adverse effects could not only be amplified in COVID-19 infections but also go clinically unrecognized and be attributed to the natural course of the disease without the close monitoring afforded by randomized, placebo-controlled trials. 2 The safety data for the first 5000 patients infected with COVID-19 and treated with convalescent plasma have revealed 36 serious adverse events, including 7 cases of transfusion-associated circulatory overload, 11 cases of transfusion-related acute lung injury, 3 cases of severe allergic reactions, 15 total deaths, and 4 deaths judged to be secondary to plasma therapy. 3 In that article, the authors provide a somewhat lukewarm support, stating convalescent plasma provides no signal of toxicity beyond what is expected in plasma use in severely ill patients and the mortality rate does not seem excessive. 3 However, this statement is made without a control group to compare. Potential for unexpected harm from convalescent plasma was recently highlighted by the presence of neutralizing immunoglobulin G autoantibodies against interferon found in 10.2% of patients with life-threatening COVID-19 and were absent in patients with mild or asymptomatic COVID-19. 4 This adds to mounting evidence of a defective type I interferon response
危及生命的Covid-19患者中针对I型IFN的自身抗体。
DOI：
10.1126/science.abd4585
发表时间：
2020-10-23
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
Bastard P;Rosen LB;Zhang Q;Michailidis E;Hoffmann HH;Zhang Y;Dorgham K;Philippot Q;Rosain J;Béziat V;Manry J;Shaw E;Haljasmägi L;Peterson P;Lorenzo L;Bizien L;Trouillet-Assant S;Dobbs K;de Jesus AA;Belot A;Kallaste A;Catherinot E;Tandjaoui-Lambiotte Y;Le Pen J;Kerner G;Bigio B;Seeleuthner Y;Yang R;Bolze A;Spaan AN;Delmonte OM;Abers MS;Aiuti A;Casari G;Lampasona V;Piemonti L;Ciceri F;Bilguvar K;Lifton RP;Vasse M;Smadja DM;Migaud M;Hadjadj J;Terrier B;Duffy D;Quintana-Murci L;van de Beek D;Roussel L;Vinh DC;Tangye SG;Haerynck F;Dalmau D;Martinez-Picado J;Brodin P;Nussenzweig MC;Boisson-Dupuis S;Rodríguez-Gallego C;Vogt G;Mogensen TH;Oler AJ;Gu J;Burbelo PD;Cohen JI;Biondi A;Bettini LR;D'Angio M;Bonfanti P;Rossignol P;Mayaux J;Rieux-Laucat F;Husebye ES;Fusco F;Ursini MV;Imberti L;Sottini A;Paghera S;Quiros-Roldan E;Rossi C;Castagnoli R;Montagna D;Licari A;Marseglia GL;Duval X;Ghosn J;HGID Lab;NIAID-USUHS Immune Response to COVID Group;COVID Clinicians;COVID-STORM Clinicians;Imagine COVID Group;French COVID Cohort Study Group;Milieu Intérieur Consortium;CoV-Contact Cohort;Amsterdam UMC Covid-19 Biobank;COVID Human Genetic Effort;Tsang JS;Goldbach-Mansky R;Kisand K;Lionakis MS;Puel A;Zhang SY;Holland SM;Gorochov G;Jouanguy E;Rice CM;Cobat A;Notarangelo LD;Abel L;Su HC;Casanova JL
通讯作者：
Casanova JL
影响因子：
4.6
作者：
Prokop, Jeremy W.;Shankar, Rama;Rajasekaran, Surender
通讯作者：
Rajasekaran, Surender
影响因子：
15.9
作者：
Joyner, Michael J.;Wright, R. Scott;Casadevall, Arturo
通讯作者：
Casadevall, Arturo