Results of the CAPSID randomized trial for high-dose convalescent plasma in patients with severe COVID-19

被引：71

作者：

Koerper, Sixten ^{[1
,2
,3
]}

Weiss, Manfred ^{[4
]}

Zickler, Daniel ^{[5
,6
,7
,8
]}

Wiesmann, Thomas ^{[9
]}

Zacharowski, Kai ^{[10
]}

Corman, Victor M. ^{[6
,7
,8
,11
,12
]}

Gruner, Beate ^{[13
]}

Ernst, Lucas ^{[5
,6
,7
,8
]}

Spieth, Peter ^{[14
]}

Lepper, Philipp M. ^{[15
]}

Bentz, Martin ^{[16
]}

Zinn, Sebastian ^{[10
]}

Paul, Gregor ^{[17
]}

Kalbhenn, Johannes ^{[18
]}

Dollinger, Matthias M. ^{[19
]}

Rosenberger, Peter ^{[20
]}

Kirschning, Thomas ^{[21
]}

Thiele, Thomas ^{[22
]}

Appl, Thomas ^{[1
,2
,3
]}

Mayer, Benjamin ^{[23
]}

Schmidt, Michael ^{[24
]}

Drosten, Christian ^{[6
,7
,8
,11
,12
]}

Wulf, Hinnerk ^{[9
]}

Kruse, Jan Matthias ^{[5
,6
,7
,8
]}

Jungwirth, Bettina ^{[4
]}

Seifried, Erhard ^{[24
]}

Schrezenmeier, Hubert ^{[1
,2
,3
]}

机构：

[1] German Red Cross Blood Transfus Serv Baden Wurtte, Inst Clin Transfus Med & Immunogenet Ulm, Frankfurt, Germany

[2] Univ Hosp Ulm, Ulm, Germany

[3] Ulm Univ, Inst Transfus Med, Ulm, Germany

[4] Ulm Univ, Univ Hosp Ulm, Dept Anaesthesiol & Intens Care Med, Ulm, Germany

[5] Charite Univ Med Berlin, Dept Nephrol & Med Intens Care, Berlin, Germany

[6] Free Univ Berlin, Berlin, Germany

[7] Humboldt Univ, Berlin, Germany

[8] Berlin Inst Hlth, Berlin, Germany

[9] Philipps Univ Marburg, Dept Anaesthesiol & Intens Care Med, Marburg, Germany

[10] Univ Hosp Frankfurt, Clin Anaesthesiol Intens Care Med & Pain Therapy, Frankfurt, Germany

[11] Charite Univ Med Berlin, Inst Virol, Berlin, Germany

[12] German Ctr Infect Res, Berlin, Germany

[13] Univ Hosp & Med Ctr Ulm, Div Infect Dis, Ulm, Germany

[14] Tech Univ Dresden, Carl Gustav Canis Univ Hosp, Dept Anesthesiol & Crit Care Med, Dresden, Germany

[15] Saarland Univ Hosp, Dept Internal Med Pneumol Allergol Intens Care Me, Homburg, Germany

[16] Hosp Karlsruhe, Dept Internal Med 3, Karlsruhe, Germany

[17] Klinikum Stuttgart, Dept Gastroenterol Hepatol Pneumol & Infect Dis, Stuttgart, Germany

[18] Univ Freiburg, Fac Med, Med Ctr, Dept Anesthesiol & Crit Care, Freiburg, Germany

[19] Klinikum Landshut, Med Clin 1, Landshut, Germany

[20] Univ Hosp Tubingen, Dept Anesthesiol & Intens Care Med, Tubingen, Germany

[21] Heidelberg Univ, Univ Med Ctr Mannheim, Dept Anaesthesiol & Surg Intens Care Med, Mannheim, Germany

[22] Univ Hosp Greifswald, Inst Immunol & Transfus Med, Greifswald, Germany

[23] Ulm Univ, Inst Epidemiol & Med Biometry, Ulm, Germany

[24] German Red Cross Blood Transfus Serv Baden Wurtte, Inst Transfus Med & Immunohematol, Frankfurt, Germany

来源：

JOURNAL OF CLINICAL INVESTIGATION | 2021年 / 131卷 / 20期

关键词：

Bundesministerium fur Gesundheit (German Federal Ministry of Health); ZMVI1-2520COR802; CORONAVIRUS DISEASE 2019;

D O I：

10.1172/JCI152264

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BACKGROUND. COVID-19 convalescent plasma (CCP) has been considered a treatment option for COVID-19. This trial assessed the efficacy of a neutralizing antibody containing high-dose CCP in hospitalized adults with COVID-19 requiring respiratory support or intensive care treatment. METHODS. Patients (n = 105) were randomized 1:1 to either receive standard treatment and 3 units of CCP or standard treatment alone. Control group patients with progress on day 14 could cross over to the CCP group. The primary outcome was a dichotomous composite outcome of survival and no longer fulfilling criteria for severe COVID-19 on day 21. RESULTS. The primary outcome occurred in 43.4% of patients in the CCP group and 32.7% in the control group (P = 0.32). The median time to clinical improvement was 26 days in the CCP group and 66 days in the control group (P = 0.27). The median time to discharge from the hospital was 31 days in the CCP group and 51 days in the control group (P = 0.24). In the subgroup that received a higher cumulative amount of neutralizing antibodies, the primary outcome occurred in 56.0% of the patients (vs. 32.1%), with significantly shorter intervals to clinical improvement (20 vs. 66 days, P < 0.05) and to hospital discharge (21 vs. 51 days, P = 0.03) and better survival (day-60 probability of survival 91.6% vs. 68.1%, P = 0.02) in comparison with the control group. CONCLUSION. CCP added to standard treatment was not associated with a significant improvement in the primary and secondary outcomes. A predefined subgroup analysis showed a significant benefit of CCP among patients who received a larger amount of neutralizing antibodies. TRIAL REGISTRATION. ClinicalTrials.gov NCT04433910.

引用

页数：13

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