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

Author

Gharbharan, Arvind, Jordans, Carlijn, Zwaginga, Lisa, Papageorgiou, Grigorios, van Geloven, Nan, van Wijngaarden, Peter, den Hollander, Jan, Karim, Faiz, van Leeuwen-Segarceanu, Elena, Soetekouw, Robert, Lammers, Jolanda, Postma, Douwe, Kampschreur, Linda, Groeneveld, Geert, Swaneveld, Francis, van der Schoot, C. Ellen, Götz, Hannelore, Haagmans, Bart, Koopmans, Marion, Bogers, Susanne, Geurtsvankessel, Corine, Zwaginga, Jaap Jan, Rokx, Casper, and Rijnders, Bart

Published
2023
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2. Outpatient convalescent plasma therapy for high-risk patients with early COVID-19:a randomized placebo-controlled trial

Author

Gharbharan, Arvind, Jordans, Carlijn, Zwaginga, Lisa, Papageorgiou, Grigorios, van Geloven, Nan, van Wijngaarden, Peter, den Hollander, Jan, Karim, Faiz, van Leeuwen-Segarceanu, Elena, Soetekouw, Robert, Lammers, Jolanda, Postma, Douwe, Kampschreur, Linda, Groeneveld, Geert, Swaneveld, Francis, van der Schoot, C. Ellen, Götz, Hannelore, Haagmans, Bart, Koopmans, Marion, Bogers, Susanne, Geurtsvankessel, Corine, Zwaginga, Jaap Jan, Rokx, Casper, Rijnders, Bart, Gharbharan, Arvind, Jordans, Carlijn, Zwaginga, Lisa, Papageorgiou, Grigorios, van Geloven, Nan, van Wijngaarden, Peter, den Hollander, Jan, Karim, Faiz, van Leeuwen-Segarceanu, Elena, Soetekouw, Robert, Lammers, Jolanda, Postma, Douwe, Kampschreur, Linda, Groeneveld, Geert, Swaneveld, Francis, van der Schoot, C. Ellen, Götz, Hannelore, Haagmans, Bart, Koopmans, Marion, Bogers, Susanne, Geurtsvankessel, Corine, Zwaginga, Jaap Jan, Rokx, Casper, and Rijnders, Bart

Abstract

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 discontinued 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.

Published
2023

4. Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients

Author

Rokx, Casper, Lammers, Jolanda, Buitenhuis, Lonneke, Postma, Douwe, Koster, David, Lukens, Michaèl, Scholtens, Thea, Boomgaard, Maartje van den, Kampschreur, Linda, Ubals, Maria, Prat, Núria, Díez Sánchez, Beatriz, Vértiz Guidotti, Thatiana, Pons Barber, Maria, Gonzalez Ruiz, Cristian, Navarrete Gonzalez, Laura, Ancochea, Àgueda, Ferrer, Magí, Videla, Sebas, Gudiol, Carlota, Fernández Rivas, Gema, CoV-Early Study Group, Vonderen, Marit van, Bianco, Andrea Sofia, Bravo, Anna, Otero, Aurema, Ruibal Suarez, Jose Carlos, Benavent, Sergio, Zarauza Pellejero, Alvaro, Línio, Rosa, Malchair, Pierre, Llopis Roca, Ferran, Blanco, Julian, Rodriguez Cortez, Orlando, Casares Gonzalez, Pablo, Arcos Vila, Gemma, García, Yolanda, Roca Font, Judit, Carrasco Matos, Katherine M., Saüch Valmaña, Glòria, Vidal Obradors, Carla, Koopmans, Marion, Ara, Jordi, COnV-ert Study Group, Rodríguez Codina, Joana, Tarres García, Silvia, Blanco, Ignacio, Hernández, Águeda, González Soler, Victoria, Curriu Sabatès, Margarida, Nieto Rodríguez, Raquel, Grífols, Joan Ramon, Briones Zambrano, Ney Nicanor, Millan, Anna, Capdevila Jáuregui, Mar, Fornos, Miriam, Casamitjana, Natàlia, Bordoy, Antoni E., Alonso, Eva, Zwet, Erik van, Miedema, Jelle, Martinez, Núria, Ramírez Morros, Anna, Bogers, Susanne, Maglio, Laura Analía, Amado Simon, Rosa, Comellas Fernandez, Laura, Garcia, Nadia, Ruiz Comellas, Anna, Baro, Bàrbara, Hernández, Luis, Viozquez Meya, Maria, Costes, Gèlia, Pradenas, Edwars, Forcada, Anna, Ginneken, Betty van, Harvala, Heli, Marfil, Silvia, Troxel, Andrea, Mooijaart, Simon, Trinité, Benjamin, Piccolo Ferreira, Francini, Bonet, Mireia, Cantoni, Jordi, Russcher, Henk, Marks, Michael, Zwaginga, Jaap Jan, Torrano Soler, Pamela, Mitjà, Oriol, Rijnders, Bart J. A., Droog, José de, Corbacho Monné, Marc, Scherpenisse, Cees, Hollander, Jan den, Gharbharan, Arvind, Jordans, Carlijn, Geurtsvankessel, Corine, Albersen, Arjan, Papageourgiou, Grigorios, Katsikis, Peter, Vall Mayans, Martí, Müller, Yvonne, Reusken, Chantal, San José, Alba, Ferrer, Susana, Engen, Rene van, Karisli, Ayten, Götz, Hannelore, Struik, Jelle, París, Alexa, Suñer Navarro, Clara, Clotet, Bonaventura, 1953, Reimerink, Johan, Rokx-Niemantsverdriet, Lotte, Rodriguez Arias, Miquel Angel, Jiménez, Zahida, Verstijnen, Jose, Geloven, Nan van, Groeneveld, Geert, Zwaginga, Lisa, Oud, Josine, Meier, Romy, González Beiras, Camila, Swaneveld, Francis, Ramírez Viaplana, Ferran, Schoot, Ellen van der, Vrielink, Hans, Flores Aguilera, Begoña, Vivero Larraza, Ainhoa, Watering, Leo van de, Hogema, Boris, González García, David, Wijngaarden, Peter van, Vidal Alaball, Josep, Etten, Ronald van, Gammeren, Adriaan van, Alemany, Andrea, Puig, Jordi, Maas, Nanda, Berg – Rahman, Juliette van der, Karim, Faiz, Hiddema, Siepke, Elst, Kim van, García García, Vanesa, Casañ Lopez, Cristina, Leeuwen-Segarceanu, Elena van, Nieto, Aroa, Rodríguez Sevilla, Graciela, Reitsma, Annette, Molenkamp, Karin, Soetekouw, Robert, Band, Caterina, Carceles Peiró, Victor, Gallardo, Mireia, Galvan Femenia, Ivan, Comas Leon, Xavier, Millat Martínez, Pere, Bassat Orellana, Quique, González, María Isabel, Verdaguer, Joaquim, Roquer López, Clàudia, Contreras, Enric, Giménez, Montserrat, Ouchi, Dan, Blanco Guillermo, Ignacio, Bonet Papell, Glòria, Dastis Arias, Macarena, Delgado Capel, Maria, Faculteit Medische Wetenschappen/UMCG, Internal Medicine, Medical Microbiology & Infectious Diseases, Virology, and Epidemiology

Subjects
Immunoregulació, Multidisciplinary, SARS-CoV-2, Immunization, Passive, Immunoregulation, COVID-19, General Physics and Astronomy, Bayes Theorem, General Chemistry, Middle Aged, General Biochemistry, Genetics and Molecular Biology, Treatment Outcome, Outpatients, Humans, Multicenter Studies as Topic, COVID-19 Serotherapy, Randomized Controlled Trials as Topic
Abstract

Data on convalescent plasma (CP) treatment in COVID-19 outpatients are scarce. We aimed to assess whether CP administered during the first week of symptoms reduced the disease progression or risk of hospitalization of outpatients. Two multicenter, double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when Trial registration: Clinicaltrials.gov NCT04621123 and NCT04589949. Registration: NCT04621123 and NCT04589949 on https://www.clinicaltrials.gov

Published
2022

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