Original Outpatient convalescent plasma therapy for high-risk patients with early COVID-19: a randomized placebo-controlled trial

被引：19

作者：

Gharbharan, Arvind ^{[1
,2
]}

Jordans, Carlijn ^{[1
,2
]}

Zwaginga, Lisa ^{[3
,4
]}

Papageorgiou, Grigorios ^{[5
]}

van Geloven, Nan ^{[6
]}

van Wijngaarden, Peter ^{[7
]}

den Hollander, Jan ^{[8
]}

Karim, Faiz ^{[9
]}

van Leeuwen-Segarceanu, Elena ^{[10
]}

Soetekouw, Robert

Lammers, Jolanda ^{[11
]}

Postma, Douwe ^{[12
]}

Kampschreur, Linda ^{[13
]}

Groeneveld, Geert ^{[14
]}

Swaneveld, Francis ^{[15
]}

van der Schoot, C. Ellen ^{[16
]}

Gotz, Hannelore ^{[17
,18
]}

Haagmans, Bart ^{[19
]}

Koopmans, Marion ^{[19
]}

Bogers, Susanne ^{[19
]}

Geurtsvankessel, Corine ^{[19
]}

Zwaginga, Jaap Jan

Rokx, Casper ^{[1
,2
]}

Rijnders, Bart ^{[1
,2
]}

机构：

[1] Erasmus MC, Univ Med Ctr, Dept Internal Med, Sect Infect Dis, Rotterdam, Netherlands

[2] Erasmus MC, Univ Med Ctr, Dept Med Microbiol & Infect Dis, Rotterdam, Netherlands

[3] Leiden Univ, Dept Haematol, Med Ctr, Leiden, Netherlands

[4] Sanquin Blood Supply, CCTR, Amsterdam, Netherlands

[5] Erasmus MC, Univ Med Ctr, Dept Biostat, Rotterdam, Netherlands

[6] Leiden Univ, Dept Biomed Data Sci, Sect Med Stat, Med Ctr, Leiden, Netherlands

[7] Amphia Hosp, Dept Internal Med, Breda, Netherlands

[8] Maasstad Ziekenhuis, Dept Internal Med, Rotterdam, Netherlands

[9] Groene Hart Hosp, Dept Internal Med, Gouda, Netherlands

[10] St Antonius Hosp, Dept Internal Med, Nieuwegein, Netherlands

[11] Isala Hosp, Dept Internal Med, Zwolle, Netherlands

[12] Univ Med Ctr Groningen, Dept Internal Med & Infect Dis, Groningen, Netherlands

[13] Med Ctr Leeuwarden, Dept Internal Med, Leeuwarden, Netherlands

[14] Leiden Univ, Dept Infect Dis & Acute Internal Med, Med Ctr, Leiden, Netherlands

[15] Sanquin Blood Supply, Unit Transfus Med, Amsterdam, Netherlands

[16] Sanquin Res, Dept Expt Immunohematol, Amsterdam, Netherlands

[17] Publ Hlth Serv Rotterdam Rijnmond, Dept Publ Hlth, Rotterdam, Netherlands

[18] Erasmus MC, Univ Med Ctr Rotterdam, Dept Publ Hlth, Rotterdam, Netherlands

[19] Erasmus MC, Dept Virosci, Rotterdam, Netherlands

来源：

CLINICAL MICROBIOLOGY AND INFECTION | 2023年 / 29卷 / 02期

关键词：

Antibodies; Convalescent plasma; COVID-19; Outpatients; Therapy;

D O I：

10.1016/j.cmi.2022.08.005

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Objectives: The potential benefit of convalescent plasma (CP) therapy for coronavirus disease 2019 (COVID-19) is highest when administered early after symptom onset. Our objective was to determine the effectiveness of CP therapy in improving the disease course of COVID-19 among high-risk outpatients. Methods: A multicentre, double-blind randomized trial was conducted comparing 300 mL of CP with non-CP. Patients were >= 50 years, were symptomatic for <8 days, had confirmed RT-PCR or antigen test result for COVID-19 and had at least one risk factor for severe COVID-19. The primary endpoint was the highest score on a 5-point ordinal scale ranging from fully recovered (score = 1) or not (score = 2) on day 7, over hospital admission (score = 3), intensive care unit admission (score = 4) and death (score = 5) in the 28 days following randomization. Secondary endpoints were hospital admission, symptom duration and viral RNA excretion. Results: After the enrolment of 421 patients and the transfusion in 416 patients, recruitment was dis-continued when the countrywide vaccination uptake in those aged >50 years was 80%. Patients had a median age of 60 years, symptoms for 5 days, and 207 of 416 patients received CP therapy. During the 28 day follow-up, 28 patients were hospitalized and two died. The OR for an improved disease severity score with CP was 0.86 (95% credible interval, 0.59-1.22). The OR was 0.58 (95% CI, 0.33-1.02) for patients with <5 days of symptoms. The hazard ratio for hospital admission was 0.61 (95% CI, 0.28-1.34). No difference was found in viral RNA excretion or in the duration of symptoms. Conclusions: In patients with early COVID-19, CP therapy did not improve the 5-point disease severity score. Arvind Gharbharan, Clin Microbiol Infect 2023;29:208 (c) 2022 The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页码：208 / 214

页数：7

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