A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia
Copyright © 2020 Massachusetts Medical Society..
BACKGROUND: Convalescent plasma is frequently administered to patients with Covid-19 and has been reported, largely on the basis of observational data, to improve clinical outcomes. Minimal data are available from adequately powered randomized, controlled trials.
METHODS: We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia in a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome was the patient's clinical status 30 days after the intervention, as measured on a six-point ordinal scale ranging from total recovery to death.
RESULTS: A total of 228 patients were assigned to receive convalescent plasma and 105 to receive placebo. The median time from the onset of symptoms to enrollment in the trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the most frequent severity criterion for enrollment. The infused convalescent plasma had a median titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to 1:3200). No patients were lost to follow-up. At day 30 day, no significant difference was noted between the convalescent plasma group and the placebo group in the distribution of clinical outcomes according to the ordinal scale (odds ratio, 0.83; 95% confidence interval [CI], 0.52 to 1.35; P = 0.46). Overall mortality was 10.96% in the convalescent plasma group and 11.43% in the placebo group, for a risk difference of -0.46 percentage points (95% CI, -7.8 to 6.8). Total SARS-CoV-2 antibody titers tended to be higher in the convalescent plasma group at day 2 after the intervention. Adverse events and serious adverse events were similar in the two groups.
CONCLUSIONS: No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo. (PlasmAr ClinicalTrials.gov number, NCT04383535.).
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:384 |
|---|---|
| Enthalten in: |
The New England journal of medicine - 384(2021), 7 vom: 18. Feb., Seite 619-629 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Simonovich, Ventura A [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antibodies, Neutralizing |
|---|
| Anmerkungen: |
Date Completed 23.02.2021 Date Revised 23.11.2023 published: Print-Electronic ClinicalTrials.gov: NCT04383535 Citation Status MEDLINE |
|---|
| doi: |
10.1056/NEJMoa2031304 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM317993194 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM317993194 | ||
| 003 | DE-627 | ||
| 005 | 20231225164424.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1056/NEJMoa2031304 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1059.xml |
| 035 | |a (DE-627)NLM317993194 | ||
| 035 | |a (NLM)33232588 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Simonovich, Ventura A |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 23.02.2021 | ||
| 500 | |a Date Revised 23.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04383535 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 Massachusetts Medical Society. | ||
| 520 | |a BACKGROUND: Convalescent plasma is frequently administered to patients with Covid-19 and has been reported, largely on the basis of observational data, to improve clinical outcomes. Minimal data are available from adequately powered randomized, controlled trials | ||
| 520 | |a METHODS: We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia in a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome was the patient's clinical status 30 days after the intervention, as measured on a six-point ordinal scale ranging from total recovery to death | ||
| 520 | |a RESULTS: A total of 228 patients were assigned to receive convalescent plasma and 105 to receive placebo. The median time from the onset of symptoms to enrollment in the trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the most frequent severity criterion for enrollment. The infused convalescent plasma had a median titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to 1:3200). No patients were lost to follow-up. At day 30 day, no significant difference was noted between the convalescent plasma group and the placebo group in the distribution of clinical outcomes according to the ordinal scale (odds ratio, 0.83; 95% confidence interval [CI], 0.52 to 1.35; P = 0.46). Overall mortality was 10.96% in the convalescent plasma group and 11.43% in the placebo group, for a risk difference of -0.46 percentage points (95% CI, -7.8 to 6.8). Total SARS-CoV-2 antibody titers tended to be higher in the convalescent plasma group at day 2 after the intervention. Adverse events and serious adverse events were similar in the two groups | ||
| 520 | |a CONCLUSIONS: No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo. (PlasmAr ClinicalTrials.gov number, NCT04383535.) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Antibodies, Neutralizing |2 NLM | |
| 650 | 7 | |a Immunoglobulin G |2 NLM | |
| 700 | 1 | |a Burgos Pratx, Leandro D |e verfasserin |4 aut | |
| 700 | 1 | |a Scibona, Paula |e verfasserin |4 aut | |
| 700 | 1 | |a Beruto, María V |e verfasserin |4 aut | |
| 700 | 1 | |a Vallone, Marcelo G |e verfasserin |4 aut | |
| 700 | 1 | |a Vázquez, Carolina |e verfasserin |4 aut | |
| 700 | 1 | |a Savoy, Nadia |e verfasserin |4 aut | |
| 700 | 1 | |a Giunta, Diego H |e verfasserin |4 aut | |
| 700 | 1 | |a Pérez, Lucía G |e verfasserin |4 aut | |
| 700 | 1 | |a Sánchez, Marisa Del L |e verfasserin |4 aut | |
| 700 | 1 | |a Gamarnik, Andrea Vanesa |e verfasserin |4 aut | |
| 700 | 1 | |a Ojeda, Diego S |e verfasserin |4 aut | |
| 700 | 1 | |a Santoro, Diego M |e verfasserin |4 aut | |
| 700 | 1 | |a Camino, Pablo J |e verfasserin |4 aut | |
| 700 | 1 | |a Antelo, Sebastian |e verfasserin |4 aut | |
| 700 | 1 | |a Rainero, Karina |e verfasserin |4 aut | |
| 700 | 1 | |a Vidiella, Gabriela P |e verfasserin |4 aut | |
| 700 | 1 | |a Miyazaki, Erica A |e verfasserin |4 aut | |
| 700 | 1 | |a Cornistein, Wanda |e verfasserin |4 aut | |
| 700 | 1 | |a Trabadelo, Omar A |e verfasserin |4 aut | |
| 700 | 1 | |a Ross, Fernando M |e verfasserin |4 aut | |
| 700 | 1 | |a Spotti, Mariano |e verfasserin |4 aut | |
| 700 | 1 | |a Funtowicz, Gabriel |e verfasserin |4 aut | |
| 700 | 1 | |a Scordo, Walter E |e verfasserin |4 aut | |
| 700 | 1 | |a Losso, Marcelo H |e verfasserin |4 aut | |
| 700 | 1 | |a Ferniot, Inés |e verfasserin |4 aut | |
| 700 | 1 | |a Pardo, Pablo E |e verfasserin |4 aut | |
| 700 | 1 | |a Rodriguez, Eulalia |e verfasserin |4 aut | |
| 700 | 1 | |a Rucci, Pablo |e verfasserin |4 aut | |
| 700 | 1 | |a Pasquali, Julieta |e verfasserin |4 aut | |
| 700 | 1 | |a Fuentes, Nora A |e verfasserin |4 aut | |
| 700 | 1 | |a Esperatti, Mariano |e verfasserin |4 aut | |
| 700 | 1 | |a Speroni, Gerardo A |e verfasserin |4 aut | |
| 700 | 1 | |a Nannini, Esteban C |e verfasserin |4 aut | |
| 700 | 1 | |a Matteaccio, Alejandra |e verfasserin |4 aut | |
| 700 | 1 | |a Michelangelo, Hernán G |e verfasserin |4 aut | |
| 700 | 1 | |a Follmann, Dean |e verfasserin |4 aut | |
| 700 | 1 | |a Lane, H Clifford |e verfasserin |4 aut | |
| 700 | 1 | |a Belloso, Waldo H |e verfasserin |4 aut | |
| 700 | 0 | |a PlasmAr Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a Simonovich, Ventura A |e investigator |4 oth | |
| 700 | 1 | |a Burgos Pratx, Leandro D |e investigator |4 oth | |
| 700 | 1 | |a Scibona, Paula |e investigator |4 oth | |
| 700 | 1 | |a Beruto, María V |e investigator |4 oth | |
| 700 | 1 | |a Vallone, Marcelo G |e investigator |4 oth | |
| 700 | 1 | |a Vázquez, Carolina |e investigator |4 oth | |
| 700 | 1 | |a Savoy, Nadia |e investigator |4 oth | |
| 700 | 1 | |a Giunta, Diego H |e investigator |4 oth | |
| 700 | 1 | |a Pérez, Lucía G |e investigator |4 oth | |
| 700 | 1 | |a Del L Sánchez, Marisa |e investigator |4 oth | |
| 700 | 1 | |a Gamarnik, Andrea Vanesa |e investigator |4 oth | |
| 700 | 1 | |a Ojeda, Diego S |e investigator |4 oth | |
| 700 | 1 | |a Santoro, Diego M |e investigator |4 oth | |
| 700 | 1 | |a Camino, Pablo J |e investigator |4 oth | |
| 700 | 1 | |a Antelo, Sebastian |e investigator |4 oth | |
| 700 | 1 | |a Rainero, Karina |e investigator |4 oth | |
| 700 | 1 | |a Vidiella, Gabriela P |e investigator |4 oth | |
| 700 | 1 | |a Miyazaki, Erica A |e investigator |4 oth | |
| 700 | 1 | |a Cornistein, Wanda |e investigator |4 oth | |
| 700 | 1 | |a Trabadelo, Omar A |e investigator |4 oth | |
| 700 | 1 | |a Ross, Fernando M |e investigator |4 oth | |
| 700 | 1 | |a Spotti, Mariano |e investigator |4 oth | |
| 700 | 1 | |a Funtowicz, Gabriel |e investigator |4 oth | |
| 700 | 1 | |a Scordo, Walter E |e investigator |4 oth | |
| 700 | 1 | |a Losso, Marcelo H |e investigator |4 oth | |
| 700 | 1 | |a Ferniot, Inés |e investigator |4 oth | |
| 700 | 1 | |a Pardo, Pablo E |e investigator |4 oth | |
| 700 | 1 | |a Rodriguez, Eulalia |e investigator |4 oth | |
| 700 | 1 | |a Rucci, Pablo |e investigator |4 oth | |
| 700 | 1 | |a Pasquali, Julieta |e investigator |4 oth | |
| 700 | 1 | |a Fuentes, Nora A |e investigator |4 oth | |
| 700 | 1 | |a Esperatti, Mariano |e investigator |4 oth | |
| 700 | 1 | |a Speroni, Gerardo A |e investigator |4 oth | |
| 700 | 1 | |a Nannini, Esteban C |e investigator |4 oth | |
| 700 | 1 | |a Matteaccio, Alejandra |e investigator |4 oth | |
| 700 | 1 | |a Michelangelo, Hernán G |e investigator |4 oth | |
| 700 | 1 | |a Follmann, Dean |e investigator |4 oth | |
| 700 | 1 | |a Lane, H Clifford |e investigator |4 oth | |
| 700 | 1 | |a Belloso, Waldo H |e investigator |4 oth | |
| 700 | 1 | |a Bonella, María B |e investigator |4 oth | |
| 700 | 1 | |a Sujodoles Gazzero, Laila |e investigator |4 oth | |
| 700 | 1 | |a Warley, Fernando |e investigator |4 oth | |
| 700 | 1 | |a Marco, María A |e investigator |4 oth | |
| 700 | 1 | |a Ko, Ery A |e investigator |4 oth | |
| 700 | 1 | |a Comisario, Agueda M |e investigator |4 oth | |
| 700 | 1 | |a Serra Frías, Florencia A |e investigator |4 oth | |
| 700 | 1 | |a Colucci, Giuliana |e investigator |4 oth | |
| 700 | 1 | |a Osorno, María S |e investigator |4 oth | |
| 700 | 1 | |a Odstrcil Bobillo, María S |e investigator |4 oth | |
| 700 | 1 | |a Huaier Arriazu, Emilio F |e investigator |4 oth | |
| 700 | 1 | |a Caccavo, Tomás |e investigator |4 oth | |
| 700 | 1 | |a Moreno Rodriguez, Rocío C |e investigator |4 oth | |
| 700 | 1 | |a Recchioni, Hernán M |e investigator |4 oth | |
| 700 | 1 | |a Guantay, Patricia E |e investigator |4 oth | |
| 700 | 1 | |a Blanco, Juan B |e investigator |4 oth | |
| 700 | 1 | |a Vázquez, Fernando J |e investigator |4 oth | |
| 700 | 1 | |a Cilenti, Flavia L |e investigator |4 oth | |
| 700 | 1 | |a Rappi, Jesica |e investigator |4 oth | |
| 700 | 1 | |a Carlone, Mauro |e investigator |4 oth | |
| 700 | 1 | |a Scherling, Anne J |e investigator |4 oth | |
| 700 | 1 | |a Adra, Sofía |e investigator |4 oth | |
| 700 | 1 | |a Amarilla, Belén |e investigator |4 oth | |
| 700 | 1 | |a Valiente, Verónica L |e investigator |4 oth | |
| 700 | 1 | |a Montoya, Danilo |e investigator |4 oth | |
| 700 | 1 | |a Delgado, Lilian |e investigator |4 oth | |
| 700 | 1 | |a Carolina, Valencia |e investigator |4 oth | |
| 700 | 1 | |a Aramberri, Debora N |e investigator |4 oth | |
| 700 | 1 | |a Veloso, Facundo |e investigator |4 oth | |
| 700 | 1 | |a Montoya, Gabriel |e investigator |4 oth | |
| 700 | 1 | |a Pons, Noelia E |e investigator |4 oth | |
| 700 | 1 | |a Gamboa, Carla V |e investigator |4 oth | |
| 700 | 1 | |a Grottola, Guillermo P |e investigator |4 oth | |
| 700 | 1 | |a Lucas, Moran |e investigator |4 oth | |
| 700 | 1 | |a Salamone, Horacio J |e investigator |4 oth | |
| 700 | 1 | |a Venuti, María S |e investigator |4 oth | |
| 700 | 1 | |a Las Heras, Marcos J |e investigator |4 oth | |
| 700 | 1 | |a Stanek, Vanina C |e investigator |4 oth | |
| 700 | 1 | |a De Paz, Mariana |e investigator |4 oth | |
| 700 | 1 | |a Brun, Noelia Y |e investigator |4 oth | |
| 700 | 1 | |a Seoane, Facundo |e investigator |4 oth | |
| 700 | 1 | |a Vernengo, Ana |e investigator |4 oth | |
| 700 | 1 | |a Arrigo, Diego |e investigator |4 oth | |
| 700 | 1 | |a Giménez, María I |e investigator |4 oth | |
| 700 | 1 | |a Molina, Lucia |e investigator |4 oth | |
| 700 | 1 | |a Larriba, Julian |e investigator |4 oth | |
| 700 | 1 | |a Tambutti, Monica |e investigator |4 oth | |
| 700 | 1 | |a Martínez von Scheidt, Marcela |e investigator |4 oth | |
| 700 | 1 | |a Bustamante, Lucrecia L |e investigator |4 oth | |
| 700 | 1 | |a Sylvestre, Vanina |e investigator |4 oth | |
| 700 | 1 | |a Peralta, Myriam B |e investigator |4 oth | |
| 700 | 1 | |a San Roman, Juan Eduardo |e investigator |4 oth | |
| 700 | 1 | |a Gonzalez Lopez Ledesma, María M |e investigator |4 oth | |
| 700 | 1 | |a Sanchez, Lautaro N |e investigator |4 oth | |
| 700 | 1 | |a Costa Navarro, Guadalupe S |e investigator |4 oth | |
| 700 | 1 | |a Pallares, Horacio M |e investigator |4 oth | |
| 700 | 1 | |a Villordo, Sergio M |e investigator |4 oth | |
| 700 | 1 | |a Alvarez, Diego E |e investigator |4 oth | |
| 700 | 1 | |a Caramelo, Julio J |e investigator |4 oth | |
| 700 | 1 | |a Carradori, Jorge |e investigator |4 oth | |
| 700 | 1 | |a Yanovsky, Marcelo J |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t The New England journal of medicine |d 1945 |g 384(2021), 7 vom: 18. Feb., Seite 619-629 |w (DE-627)NLM000008184 |x 1533-4406 |7 nnns |
| 773 | 1 | 8 | |g volume:384 |g year:2021 |g number:7 |g day:18 |g month:02 |g pages:619-629 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1056/NEJMoa2031304 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 384 |j 2021 |e 7 |b 18 |c 02 |h 619-629 | ||