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Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study

Rojas et al., BMC Infectious Diseases, doi:10.1186/s12879-022-07560-7, NCT04332835
Jun 2022  
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Mortality -220% Improvement Relative Risk Discharge 38% Viral clearance, day 4 -25% Viral clearance, day 7 -16% Viral clearance, day 14 -51% Viral clearance, day 28 -12% Conv. Plasma  Rojas et al.  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 91 patients in Colombia (August - November 2020) Higher discharge with convalescent plasma (p=0.038) c19early.org Rojas et al., BMC Infectious Diseases, Jun 2022 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
RCT 91 hospitalized patients in Colombia showing shorter time to discharge with convalescent plasma, but higher mortality (without statistical significance).
risk of death, 220.0% higher, HR 3.20, p = 0.16, treatment 46, control 45, Cox proportional hazards.
risk of no hospital discharge, 37.5% lower, HR 0.62, p = 0.04, treatment 46, control 45, inverted to make HR<1 favor treatment, Cox proportional hazards.
risk of no viral clearance, 25.0% higher, OR 1.25, p = 0.72, treatment 46, control 45, adjusted per study, mid-recovery, day 4, RR approximated with OR.
risk of no viral clearance, 16.0% higher, OR 1.16, p = 0.82, treatment 46, control 45, adjusted per study, day 7, RR approximated with OR.
risk of no viral clearance, 51.0% higher, OR 1.51, p = 0.60, treatment 46, control 45, adjusted per study, day 14, RR approximated with OR.
risk of no viral clearance, 12.0% higher, OR 1.12, p = 0.91, treatment 46, control 45, adjusted per study, day 28, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Rojas et al., 27 Jun 2022, Single Blind Randomized Controlled Trial, Colombia, peer-reviewed, 45 authors, study period 8 August, 2020 - 13 November, 2020, average treatment delay 11.0 days, trial NCT04332835 (history). Contact: anayajm@gmail.com (corresponding author).
This PaperConv. PlasmaAll
Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study
Manuel Rojas, Yhojan Rodríguez, Juan Carlos Hernández, Juan C Díaz-Coronado, José Alejandro Daza Vergara, Verónica Posada Vélez, Jessica Porras Mancilla, Iván Araujo, Jairo Torres Yepes, Oscar Briceño Ricaurte, Juan Mauricio Pardo-Oviedo, Diana M Monsalve, Yeny Acosta-Ampudia, Carolina Ramírez-Santana, Paula Gaviria García, Lina Acevedo Landinez, Luisa Duarte Correales, Jeser Santiago Grass, Cristian Ricaurte Pérez, Gustavo Salguero López, Nataly Mateus, Laura Mancera, Ronald Rengifo Devia, Juan Esteban Orjuela, Christian R Parra-Moreno, Andrés Alfonso Buitrago, Inés Elvira Ordoñez, Claudia Fabra Osorio, Nathalia Ballesteros, Luz H Patiño, Sergio Castañeda, Marina Muñoz, Juan David Ramírez, Paul Bastard, Adrian Gervais, Lucy Bizien, Jean-Laurent Casanova, Bernardo Camacho, Juan Esteban Gallo, Oscar Gómez, Adriana Rojas-Villarraga, Carlos E Pérez, Rubén Manrique, Rubén D Mantilla, Juan-Manuel Anaya
BMC Infectious Diseases, doi:10.1186/s12879-022-07560-7
Background: Convalescent plasma (CP) has been widely used to treat COVID-19 and is under study. However, the variability in the current clinical trials has averted its wide use in the current pandemic. We aimed to evaluate the safety and efficacy of CP in severe coronavirus disease 2019 (COVID-19) in the early stages of the disease. Methods: A randomized controlled clinical study was conducted on 101 patients admitted to the hospital with confirmed severe COVID-19. Most participants had less than 14 days from symptoms onset and less than seven days from hospitalization. Fifty patients were assigned to receive CP plus standard therapy (ST), and 51 were assigned to receive ST alone. Participants in the CP arm received two doses of 250 mL each, transfused 24 h apart. All transfused plasma was obtained from "super donors" that fulfilled the following criteria: titers of anti-SARS-CoV-2 S1 IgG ≥ 1:3200 and IgA ≥ 1:800 antibodies. The effect of transfused anti-IFN antibodies and the SARS-CoV-2 variants at the entry of the study on the overall CP efficacy was evaluated. The primary outcomes were the reduction in viral load and the increase in IgG and IgA antibodies at 28 days of follow-up. The per-protocol analysis included 91 patients. Results: An early but transient increase in IgG anti-S1-SARS-CoV-2 antibody levels at day 4 post-transfusion was observed (Estimated difference [ED], − 1.36; 95% CI, − 2.33 to − 0.39; P = 0.04). However, CP was not associated with viral load reduction in any of the points evaluated. Analysis of secondary outcomes revealed that those patients in the CP arm disclosed a shorter time to discharge (ED adjusted for mortality, 3.1 days; 95% CI, 0.20 to 5.94; P = 0.0361) or a reduction of 2 points on the WHO scale when compared with the ST group (HR adjusted for mortality, 1.6; 95% CI, 1.03
Abbreviations Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s12879-022-07560-7. Additional file 1. Lineages and mutations of interest in the studied population. Author contributions Declarations Ethics approval and consent to participate The institutional review board of the Universidad del Rosario approved the study design (Act. 421 CEI-UR). Written informed consent was obtained from all participants, and the trial was conducted following the principles stated in the Declaration of Helsinki and Good Clinical Practice guidelines. Consent for publication All participants provided consent to publish. Competing interests None. Author contributions Conceptualization: JMA, JEG, RM; Acquisition of data: YR, JCH, JCD, JAD, VPV, JPM, IA, JTY, OBR, JMPO, DMM, YAA, CRS, PGG JSG, CRP, GSL, NM, LM, RRD, JEO, CRPM, AAB, ARV, CEP; Methodology: JMA, ARV, RM, GSL, JEG, BC; Statistical Analysis: MR, RM, JMA; Funding acquisition: JMA, BC, RM; Procurement of convalescent plasma: PGG, LAL, LDC, JSG, CRP, GSL, BC; Center Coordination: CF; Monitoring: IEO; Variants analysis: NB, LHP, SC, MM, JDR; Anti-IFN antibodies: PB, AG, LB, J-LC; Writing and editing: MR, JMA. All authors read and approved the final manuscript. • fast, convenient online submission • thorough peer review by experienced researchers in your field • rapid publication on acceptance • support for research data, including large and complex data..
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However, the variability in the current clinical trials has averted its ' 'wide use in the current pandemic. We aimed to evaluate the safety and efficacy of CP in ' 'severe coronavirus disease 2019 (COVID-19) in the early stages of the disease.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>A randomized controlled clinical study was conducted on 101 patients ' 'admitted to the hospital with confirmed severe COVID-19. Most participants had less than ' '14\xa0days from symptoms onset and less than seven days from hospitalization. Fifty patients ' 'were assigned to receive CP plus standard therapy (ST), and 51 were assigned to receive ST ' 'alone. Participants in the CP arm received two doses of 250\xa0mL each, transfused 24\xa0h ' 'apart. All transfused plasma was obtained from "super donors" that fulfilled the following ' 'criteria: titers of anti-SARS-CoV-2 S1 IgG\u2009≥\u20091:3200 and IgA\u2009≥\u20091:800 ' 'antibodies. The effect of transfused anti-IFN antibodies and the SARS-CoV-2 variants at the ' 'entry of the study on the overall CP efficacy was evaluated. The primary outcomes were the ' 'reduction in viral load and the increase in IgG and IgA antibodies at 28\xa0days of ' 'follow-up. The per-protocol analysis included 91 patients.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>An early but transient increase in IgG anti-S1-SARS-CoV-2 antibody ' 'levels at day 4 post-transfusion was observed (Estimated difference [ED],\u2009−\u20091.36; ' '95% CI,\u2009−\u20092.33 to\u2009−\u20090.39; P\u2009=\u20090.04). However, CP was not ' 'associated with viral load reduction in any of the points evaluated.\xa0Analysis of secondary ' 'outcomes revealed that those patients in the CP arm disclosed a shorter time to discharge (ED ' 'adjusted for mortality, 3.1\xa0days; 95% CI, 0.20 to 5.94; P\u2009=\u20090.0361) or a ' 'reduction of 2 points on the WHO scale when compared with the ST group (HR adjusted for ' 'mortality, 1.6; 95% CI, 1.03 to 2.5; P\u2009=\u20090.0376). There were no benefits from CP on ' 'the rates of intensive care unit admission (HR, 0.82; 95% CI, 0.35 to 1.9; P\u2009=\u2009' '0.6399), mechanical ventilation (HR, 0.66; 95% CI, 0.25 to 1.7; P\u2009=\u20090.4039), or ' 'mortality (HR, 3.2; 95% CI, 0.64 to 16; P\u2009=\u20090.1584). 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The Lancet Microbe. 2021;2: ' 'e138.', 'journal-title': 'The Lancet Microbe'}], 'container-title': 'BMC Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-022-07560-7.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s12879-022-07560-7/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-022-07560-7.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 6, 27]], 'date-time': '2022-06-27T06:03:25Z', 'timestamp': 1656309805000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-022-07560-7'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 6, 27]]}, 'references-count': 56, 'journal-issue': {'issue': '1', 'published-print': {'date-parts': [[2022, 12]]}}, 'alternative-id': ['7560'], 'URL': 'http://dx.doi.org/10.1186/s12879-022-07560-7', 'relation': {}, 'ISSN': ['1471-2334'], 'subject': ['Infectious Diseases'], 'container-title-short': 'BMC Infect Dis', 'published': {'date-parts': [[2022, 6, 27]]}, 'assertion': [ { 'value': '6 March 2022', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '25 May 2022', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '27 June 2022', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'The institutional review board of the Universidad del Rosario approved the ' 'study design (Act. 421 CEI-UR). Written informed consent was obtained from all ' 'participants, and the trial was conducted following the principles stated in ' 'the Declaration of Helsinki and Good Clinical Practice guidelines.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'All participants provided consent to publish.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'None.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}, { 'value': 'Conceptualization: JMA, JEG, RM; Acquisition of data: YR, JCH, JCD, JAD, VPV, ' 'JPM, IA, JTY, OBR, JMPO, DMM, YAA, CRS, PGG JSG, CRP, GSL, NM, LM, RRD, JEO, ' 'CRPM, AAB, ARV, CEP; Methodology: JMA, ARV, RM, GSL, JEG, BC; Statistical ' 'Analysis: MR, RM, JMA; Funding acquisition: JMA, BC, RM; Procurement of ' 'convalescent plasma: PGG, LAL, LDC, JSG, CRP, GSL, BC; Center Coordination: CF; ' 'Monitoring: IEO; Variants analysis: NB, LHP, SC, MM, JDR; Anti-IFN antibodies: ' 'PB, AG, LB, J-LC; Writing and editing: MR, JMA. All authors read and approved ' 'the final manuscript.', 'order': 5, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Author contributions'}}], 'article-number': '575'}
Late treatment
is less effective
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