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0 0.5 1 1.5 2+ Mortality 80% Improvement Relative Risk Hospitalization -5% Recovery -5% Viral load, day 28 -4% Viral load, day 7 4% Conv. Plasma  Alemany et al.  EARLY TREATMENT  DB RCT Is early treatment with convalescent plasma beneficial for COVID-19? Double-blind RCT 376 patients in Spain (November 2020 - July 2021) Lower mortality with convalescent plasma (not stat. sig., p=0.5) c19early.org Alemany et al., The Lancet Respiratory.., Feb 2022 Favors conv. plasma Favors control

High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomised, placebo-controlled trial

Alemany et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(21)00545-2, NCT04621123
Feb 2022  
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RCT 188 convalescent plasma and 188 control patients, showing no significant difference in outcomes.
risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 188 (0.0%), control 2 of 188 (1.1%), NNT 94, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 4.8% higher, RR 1.05, p = 1.00, treatment 22 of 188 (11.7%), control 21 of 188 (11.2%).
risk of no recovery, 5.0% higher, HR 1.05, p = 0.67, treatment 188, control 188, time to symptom resolution.
viral load, 3.6% higher, relative load 1.04, p = 0.33, treatment 188, control 188, relative change in viral load, day 28.
viral load, 3.7% lower, relative load 0.96, p = 0.42, treatment 188, control 188, relative change in viral load, day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Alemany et al., 9 Feb 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Spain, peer-reviewed, median age 56.0, 108 authors, study period 10 November, 2020 - 28 July, 2021, trial NCT04621123 (history). Contact: aalemany@flsida.org.
This PaperConv. PlasmaAll
High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomised, placebo-controlled trial
MD Andrea Alemany, MD Pere Millat-Martinez, Hospital Clinic ( Marc Corbacho-Monné, Pierre Malchair, Dan Ouchi, Anna Ruiz-Comellas, Anna Ramírez-Morros, Joana Rodríguez Codina, Rosa Amado Simon, Sebastian Videla, Gèlia Costes, Mar Capdevila-Jáuregui, Pamela Torrano-Soler, Alba San José, Glòria Bonet Papell, Jordi Puig, Aurema Otero, Jose Carlos Ruibal Suarez, Alvaro Zarauza Pellejero, Ferran Llopis Roca, Orlando Rodriguez Cortez, Vanesa Garcia Garcia, Josep Vidal-Alaball, Anna Millan, Enric Contreras, Joan-Ramon Grifols, Àgueda Ancochea, Ivan Galvan-Femenia, Francini Piccolo Ferreira, Mireia Bonet, Jordi Cantoni, Núria Prat, Jordi Ara, Anna Forcada Arcarons, Magí Farré, Edwards Pradenas, Julià Blanco, Miquel Àngel Rodriguez-Arias, Gema Fernández Rivas, Michael Marks, Quique Bassat, Ignacio Blanco, Bàrbara Baro, Bonaventura Clotet, Oriol Mitjà, Susana Ferrer, Mireia Gallardo, Maria Ubals, Camila González-Beiras, Martí Vall-Mayans, Clara Suñer, Clàudia Laporte-Villar, Aroa Nieto, Xavier Comas-Leon, Zahida Jiménez, Ferran Ramírez-Viaplana, Maria Delgado-Capel, Beatriz Díez Sánchez, Maria Pons Barber, Cristian Gonzalez Ruiz, Laura Navarrete Gonzalez, David González García, Ainhoa Vivero Larraza, Victor Carceles Peiró, Clàudia Roquer López, Neus Robert, Carles Palet, Carlota Gudiol, Pablo Casares Gonzalez, Gemma Arcos Vila, Begoña Flores Aguilera, Graciela Rodríguez-Sevilla, Macarena Dastis Arias, Judit Roca Font, Katherine M Carrasco Matos, Glòria Saüch Valmaña, Carla Vidal Obradors, Silvia Tarres García, Margarida Curriu Sabatès, Raquel Nieto Rodríguez, Rosa Línio, Míriam Fornos, Natàlia Casamitjana, Eva Alonso, Núria Martínez, Laura Analía Maglio, Laura Comellas Fernandez, Nadia Garcia, Luis Hernández, Maria Isabel González, Anna Bravo, Yolanda García, Silvia Sauleda Oliveras, Tatiana Vertiz, Sergio Benavent, Andrea Sofia Bianco, Joaquim Verdaguer, Ney Nicanor Briones Zambrano, Maria Viozquez Meya, Águeda Hernández, Cristina Casaña Lopez, Antoni E Bordoy, Victoria González Soler, Montserrat Giménez, Alexa París, Silvia Marfil, Benjamin Trinité, Eulàlia Grau
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(21)00545-2
Background Convalescent plasma has been proposed as an early treatment to interrupt the progression of early COVID-19 to severe disease, but there is little definitive evidence. We aimed to assess whether early treatment with convalescent plasma reduces the risk of hospitalisation and reduces SARS-CoV-2 viral load among outpatients with COVID-19. Methods We did a multicentre, double-blind, randomised, placebo-controlled trial in four health-care centres in Catalonia, Spain. Adult outpatients aged 50 years or older with the onset of mild COVID-19 symptoms 7 days or less before randomisation were eligible for enrolment. Participants were randomly assigned (1:1) to receive one intravenous infusion of either 250-300 mL of ABO-compatible high anti-SARS-CoV-2 IgG titres (EUROIMMUN ratio ≥6) methylene blue-treated convalescent plasma (experimental group) or 250 mL of sterile 0•9% saline solution (control). Randomisation was done with the use of a central web-based system with concealment of the trial group assignment and no stratification. To preserve masking, we used opaque tubular bags that covered the investigational product and the infusion catheter. The coprimary endpoints were the incidence of hospitalisation within 28 days from baseline and the mean change in viral load (in log 10 copies per mL) in nasopharyngeal swabs from baseline to day 7. The trial was stopped early following a data safety monitoring board recommendation because more than 85% of the target population had received a COVID-19 vaccine. Primary efficacy analyses were done in the intentionto-treat population, safety was assessed in all patients who received the investigational product. This study is registered with ClinicalTrials.gov, NCT04621123. Findings Between Nov 10, 2020, and July 28, 2021, we assessed 909 patients with confirmed COVID-19 for inclusion in the trial, 376 of whom were eligible and were randomly assigned to treatment (convalescent plasma n=188 [serum antibody-negative n=160]; placebo n=188 [serum antibody-negative n=166]). Median age was 56 years (IQR 52-62) and the mean symptom duration was 4•4 days (SD 1•4) before random assignment. In the intention-to-treat population, hospitalisation within 28 days from baseline occurred in 22 (12%) participants who received convalescent plasma versus 21 (11%) who received placebo (relative risk 1•05 [95% CI 0•78 to 1•41]). The mean change in viral load from baseline to day 7 was -2•41 log 10 copies per mL (SD 1•32) with convalescent plasma and -2•32 log 10 copies per mL (1•43) with placebo (crude difference -0•10 log 10 copies per mL [95% CI -0•35 to 0•15]). One participant with mild COVID-19 developed a thromboembolic event 7 days after convalescent plasma infusion, which was reported as a serious adverse event possibly related to COVID-19 or to the experimental intervention. Interpretation Methylene blue-treated convalescent plasma did not prevent progression from mild to severe illness and did not reduce viral load in..
company, Grifols Worldwide Operations (Dublin, Ireland), and the Crowdfunding campaign, YoMeCorono. The study received support from the Hospital Universitari Germans Trias i Pujol, and Banc de Sang i Teixits de Catalunya. We thank Gerard Carot-Sans for providing medical writing support with manuscript preparation and Roser Escrig for her support in the study design and medical writing assistance with the study documentation. We also thank Laia Bertran, Mireia Clua, Jordi Mitjà, Claudia Laporte, Sergi Gavilan, Joan Mercado, and Enric Nieto for the operational and financial management of the project. We thank the personnel from the Fight Aids and Infectious Diseases Foundation for their support in administration, human resources, and supply chain management. We thank the independent data safety monitoring board for their time and dedication: Cinta Hierro (Catalan Institute of Oncology, Badalona, Spain), Natalia Tovar (Hospital Clinic, Barcelona, Spain), Binh Ngo (University of Southern California, Los Angeles, CA, USA), David Boulware (University of Minnesota, Minneapolis, MN, USA), and Robin Mogg (Bill and Melinda Gates Research Institute, Seattle, WA, USA). We thank the reviewers for substantial comments that helped improve and clarify the strengths and drawbacks of the experimental intervention and study methodology.
References
Abani, Abbas, Abbas, Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial, Lancet
Agarwal, Mukherjee, Kumar, Chatterjee, Bhatnagar et al., Convalescent plasma in the management of moderate COVID-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial), BMJ
Alqahtani, Abdulrahman, Almadani, Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease, Sci Rep
Avendaño-Solá, Ramos-Martínez, Muñez-Rubio, A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia, J Clin Invest
Bajpai, Kumar, Maheshwari, Efficacy of Convalescent Plasma Therapy compared to Fresh Frozen Plasma in Severely ill COVID-19 Patients: A Pilot Randomized Controlled Trial, medRxiv, doi:10.1101/2020.10.25.20219337
Balcells, Rojas, Corre, Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: a randomized phase II clinical trial, PLoS Med
Bratcher-Bowman, Convalescent plasma EUA letter of authorization March 9
Bégin, Callum, Jamula, Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial, Nat Med
Cao, Wang, Jian, Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies, bioRxiv, doi:10.1101/2021.12.07.470392
Deeks, Higgins, Statistical algorithms in Review Manager 5
Dougan, Nirula, Azizad, Bamlanivimab plus etesevimab in mild or moderate COVID-19, N Engl J Med
Focosi, Franchini, Pirofski, COVID-19 convalescent plasma is more than neutralizing antibodies: a narrative review of potential beneficial and detrimental co-factors, Viruses
Gharbharan, Jordans, Geurtsvankessel, Effects of potent neutralizing antibodies from convalescent plasma in patients hospitalized for severe SARS-CoV-2 infection, Nat Commun
Gottlieb, Nirula, Chen, Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial, JAMA
Horby, Mafham, Peto, Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial, doi:10.1101/2021.06.15.21258542
Janiaud, Axfors, Schmitt, Association of convalescent plasma treatment with clinical outcomes in patients with COVID-19: a systematic review and meta-analysis, JAMA
Katz, A little) clarity on convalescent plasma for COVID-19, N Engl J Med
Kermali, Khalsa, Pillai, Ismail, Harky, The role of biomarkers in diagnosis of COVID-19-a systematic review, Life Sci
Korley, Durkalski-Mauldin, Yeatts, Early convalescent plasma for high-risk outpatients with COVID-19, N Engl J Med
Kostin, Lundgren, Bulanov, Impact of pathogen reduction methods on immunological properties of the COVID-19 convalescent plasma, Vox Sang
Kunze, Johnson, Van Helmond, Mortality in individuals treated with COVID-19 convalescent plasma varies with the geographic provenance of donors, Nat Commun
Larrea, Castro, Navarro, Preservation of anti-SARS-CoV-2 neutralising antibodies in convalescent plasma after pathogen reduction with methylene blue and visible light, Blood Transfus, doi:10.2450/2021.0136-21
Li, Zhang, Hu, Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and lifethreatening COVID-19: a randomized clinical trial, JAMA
Libster, Marc, Wappner, Early high-titer plasma therapy to prevent severe COVID-19 in older adults, N Engl J Med
Mair-Jenkins, Saavedra-Campos, Baillie, The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis, J Infect Dis
Marshall, Murthy, Diaz, A minimal common outcome measure set for COVID-19 clinical research, Lancet Infect Dis
O'donnell, Grinsztejn, Cummings, A randomized, double-blind controlled trial of convalescent plasma in adults with severe COVID-19, J Clin Invest
Raster, Zimmermann, Wesche, Aurich, Greinacher et al., Effect of methylene blue pathogen inactivation on the integrity of immunoglobulin M and G, Transfus Med Hemother
Ray, Paul, Bandopadhyay, Clinical and immunological benefits of convalescent plasma therapy in severe COVID-19: insights from a single center open label randomised control trial, medRxiv, doi:10.1101/2020.11.25.20237883
Ross, Photodynamic action of methylene blue on antipneumococcal serum, J Immunol
Simonovich, Pratx, Scibona, A randomized trial of convalescent plasma in COVID-19 severe pneumonia, N Engl J Med
Trinité, Pradenas, Marfil, Previous SARS-CoV-2 infection increases B.1.1.7 cross-neutralization by vaccinated individuals, Viruses
Trinité, Tarrés-Freixas, Rodon, SARS-CoV-2 infection elicits a rapid neutralizing antibody response that correlates with disease severity, Sci Rep
Wang, Nair, Liu, Antibody resistance of SARS-CoV-2 variants B.1.351 and B.1.1.7, Nature
Weinreich, Sivapalasingam, Norton, REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-19, N Engl J Med
Wilhelm, Widera, Grikscheit, Reduced neutralization of SARS-CoV-2 omicron variant by vaccine sera and monoclonal antibodies, medRxiv, doi:10.1101/2021.12.07.21267432
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