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--- 460fd5d8-4da5-11ee-8551-d4ae52ce2496 [2023/09/07 18:08] – created omnipedia
+++ 460fd5d8-4da5-11ee-8551-d4ae52ce2496 [2023/09/07 21:04] (current) – [COVID-19 and Hyperimmune Convalescent Plasma Therapy] omnipedia
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 ===== Introduction =====
 Convalescent plasma therapy, often referred to as passive antibody therapy, constitutes a therapeutic intervention wherein blood plasma derived from individuals convalescing from a specific infectious ailment is employed to treat contemporaneously afflicted patients. The principal objective of this therapy lies in conferring immediate passive immunity to the recipient by means of preformed antibodies against the causative pathogen, thereby potentially ameliorating the course of the ongoing malady.
 ===== Historical Background =====
@@ Line 27: / Line 27: @@
 ===== COVID-19 and Hyperimmune Convalescent Plasma Therapy =====
-In 2019, a new type of coronavirus, known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), led to the outbreak of coronavirus disease 2019 (COVID-19), rapidly spreading worldwide after its initial identification in Wuhan, China. In the early months of 2020, the application of convalescent plasma began in specific cases and small-scale instances in both China and Italy. The broader implementation of convalescent plasma therapy in the United States was facilitated through a Mayo Clinic-led Expanded Access Program for convalescent plasma, followed by an Emergency Use Authorization granted by the United States Food & Drug Administration. Data derived from the Expanded Access Program indicated that patients not requiring mechanical ventilation who received high-titer convalescent plasma exhibited lower mortality rates compared to those administered low-titer convalescent plasma (14.2% vs. 22.2%).
+In 2019, a new type of coronavirus, known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), led to the outbreak of coronavirus disease 2019 (COVID-19), rapidly spreading worldwide after its initial identification in Wuhan, China. In the early months of 2020, the application of convalescent plasma began in specific cases and small-scale instances in both China and Italy. [(RefNumber1>>
+authors: Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, et al.
+title: Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial
+url: https://doi.org/10.1001/jama.2020.10044
+published: August 2020
+journal: JAMA. 324 (5): 460–470.
+)]
+[(RefNumber2>>
+authors: Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, et al.
+title: Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma
+url: https://doi.org/10.1001/jama.2020.4783
+published: April 2020
+journal: JAMA. 323 (16): 1582–1589.
+)]
+[(RefNumber3>>
+authors: Perotti C, Baldanti F, Bruno R, Del Fante C, Seminari E, Casari S, et al.
+title: Mortality reduction in 46 severe Covid-19 patients treated with hyperimmune plasma. A proof of concept single arm multicenter trial
+url: https://doi.org/10.3324/haematol.2020.261784
+published: December 2020
+journal: Haematologica. 105 (12): 2834–2840.
+)]
+The broader implementation of convalescent plasma therapy in the United States was facilitated through a Mayo Clinic-led Expanded Access Program for convalescent plasma, [(RefNumber4>>
+authors: Senefeld JW, Johnson PW, Kunze KL, Bloch EM, van Helmond N, Golafshar MA, et al.
+title: Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study
+url: https://doi.org/10.1371/journal.pmed.1003872
+published: December 2021
+journal: PLOS Medicine. 18 (12): e1003872.
+)]
+followed by an Emergency Use Authorization granted by the United States Food & Drug Administration. [(RefNumber5>>
+title: FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment
+published: August 23, 2020
+publisher: Food and Drug Administration.
+url: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment
+)]
+Data derived from the Expanded Access Program indicated that patients not requiring mechanical ventilation who received high-titer convalescent plasma exhibited lower mortality rates compared to those administered low-titer convalescent plasma (14.2% vs. 22.2%). [(RefNumber15>>
+authors: Joyner MJ, Carter RE, Senefeld JW, Klassen SA, Mills JR, Johnson PW, et al.
+title: Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19
+url: https://doi.org/10.1056/NEJMoa2031893
+published: March 2021
+journal: The New England Journal of Medicine. 384 (11): 1015–1027.
+)]
-During the initial stages of the pandemic, several randomized controlled trials concluded that convalescent plasma therapy was not effective for COVID-19. Notably, most of these trials focused on patients who were already seropositive or in the advanced stages of the disease and/or used plasma units with inadequate antibody levels. Conversely, randomized controlled trials that directed their attention towards the early administration of high-titer convalescent plasma following diagnosis demonstrated a substantial reduction in hospital admissions, ranging from approximately 50-80%. This outcome aligns with the effectiveness achieved with monoclonal antibodies and small-molecule antiviral agents.
+During the initial stages of the pandemic, several randomized controlled trials concluded that convalescent plasma therapy was not effective for COVID-19. Notably, most of these trials focused on patients who were already seropositive or in the advanced stages of the disease and/or used plasma units with inadequate antibody levels. [(RefNumber6>>
+authors: Simonovich VA, Burgos Pratx LD, Scibona P, Beruto MV, Vallone MG, Vázquez C, et al.
+title: A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia
+url: https://doi.org/10.1056/NEJMoa2031304
+published: February 2021
+journal: The New England Journal of Medicine. 384 (7): 619–629.
+)]
+[(RefNumber7>>
+authors: Abani O, Abbas A, Abbas F, Abbas M, Abbasi S, Abbass H, et al. (RECOVERY Collaborative Group)
+title: Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial
+url: https://doi.org/10.1016/S0140-6736(21)00897-7
+published: May 2021
+journal: Lancet. 397 (10289): 2049–2059.
+)]
+[(RefNumber8>>
+authors: Agarwal A, Mukherjee A, Kumar G, Chatterjee P, Bhatnagar T, Malhotra P
+title: Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial)
+url: https://doi.org/10.1136/bmj.m3939
+published: October 2020
+journal: BMJ. 371: m3939.
+)]
+[(RefNumber9>>
+authors: Bégin P, Callum J, Heddle NM, Cook R, Zeller MP, Tinmouth A, et al.
+title: Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial
+url: https://doi.org/10.1186/s13063-021-05235-3
+published: May 2021
+journal: Trials. 22 (1): 323.
+)]
+[(RefNumber10>>
+authors: Estcourt LJ, Turgeon AF, McQuilten ZK, McVerry BJ, Al-Beidh F, Annane D, et al.
+title: Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial
+url: https://doi.org/10.1001/jama.2021.18178
+published: November 2021
+journal: JAMA. 326 (17): 1690–1702.
+)]
+[(RefNumber11>>
+authors: Focosi D, Franchini M, Pirofski LA, Burnouf T, Paneth N, Joyner MJ, Casadevall A
+title: COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes
+url: https://doi.org/10.1128/cmr.00200-21
+published: March 2022
+journal: Clinical Microbiology Reviews. 35 (3): e0020021.
+)]
+Conversely, randomized controlled trials that directed their attention towards the early administration of high-titer convalescent plasma following diagnosis demonstrated a substantial reduction in hospital admissions, ranging from approximately 50-80%. [(RefNumber16>>
+authors: Libster R, Pérez Marc G, Wappner D, Coviello S, Bianchi A, Braem V, et al.
+title: Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults
+url: https://doi.org/10.1056/NEJMoa2033700
+published: February 2021
+journal: The New England Journal of Medicine. 384 (7): 610–618.
+)]
+[(RefNumber12>>
+authors: Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, et al.
+title: Early Outpatient Treatment for Covid-19 with Convalescent Plasma
+url: https://doi.org/10.1056/NEJMoa2119657
+published: May 2022
+journal: The New England Journal of Medicine. 386 (18): 1700–1711.
+)]
+This outcome aligns with the effectiveness achieved with monoclonal antibodies and small-molecule antiviral agents. [(RefNumber13>>
+authors: Sullivan DJ, Focosi D, Hanley D, Franchini M, Ou J, Casadevall A, Paneth N
+title: Effective antiviral regimens to reduce COVID-19 hospitalizations: a systematic comparison of randomized controlled trials
+url: https://doi.org/10.1101/2022.05.24.22275478
+published: May 2022
+journal: medRxiv.
+)]
-An epidemiological analysis examining the utilization of convalescent plasma and subsequent mortality rates in the United States revealed a robust inverse correlation, presenting compelling evidence of its effectiveness at a population-wide level. Based on this data, it was estimated that the deployment of convalescent plasma potentially averted roughly 100,000 fatalities in the United States.
+An epidemiological analysis examining the utilization of convalescent plasma and subsequent mortality rates in the United States revealed a robust inverse correlation, presenting compelling evidence of its effectiveness at a population-wide level. Based on this data, it was estimated that the deployment of convalescent plasma potentially averted roughly 100,000 fatalities in the United States. [(RefNumber14>>
+authors: Casadevall A, Dragotakes Q, Johnson PW, Senefeld JW, Klassen SA, Wright RS, et al.
+title: Convalescent plasma use in the USA was inversely correlated with COVID-19 mortality
+url: https://doi.org/10.7554/eLife.69866
+published: June 2021
+journal: eLife. 10: e69866.
+)]
+===== Riferimenti =====
+~~REFNOTES~~