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--- 460fd5d8-4da5-11ee-8551-d4ae52ce2496 [2023/09/07 20:38] – [COVID-19 and Hyperimmune Convalescent Plasma Therapy] 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>>
-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.
-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.
-[(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
@@ Line 54: / Line 48: @@
 journal: Haematologica. 105 (12): 2834–2840.
 )]
-[(RefNumber4>>
+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
@@ Line 61: / Line 55: @@
 journal: PLOS Medicine. 18 (12): e1003872.
 )]
-[(RefNumber5>>
+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
@@ Line 67: / Line 61: @@
 url: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment
 )]
-[(RefNumber6>>
+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. [(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
@@ Line 101: / Line 103: @@
 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
@@ Line 108: / Line 110: @@
 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>>
@@ Line 116: / Line 125: @@
 journal: The New England Journal of Medicine. 386 (18): 1700–1711.
 )]
-[(RefNumber13>>
+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
@@ Line 123: / Line 132: @@
 journal: medRxiv.
 )]
-[(RefNumber14>>
+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
@@ Line 130: / Line 140: @@
 journal: eLife. 10: e69866.
 )]
 ===== Riferimenti =====