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0 0.5 1 1.5 2+ Mortality, day 28 -3% Improvement Relative Risk Mortality, day 14 -26% 7-point scale -4% primary Conv. Plasma  PassItOn  LATE TREATMENT  DB RCT Is late treatment with convalescent plasma beneficial for COVID-19? Double-blind RCT 960 patients in the USA (April 2020 - June 2021) No significant difference in outcomes seen Self et al., Chest, November 2022 Favors conv. plasma Favors control

Neutralizing COVID-19 Convalescent Plasma in Adults Hospitalized With COVID-19

Self et al., Chest, doi:10.1016/j.chest.2022.06.029, PassItOn, NCT04362176
Nov 2022  
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RCT 947 hospitalized patients in the USA, showing no signficant difference with convalescent plasma treatment.
risk of death, 3.3% higher, RR 1.03, p = 0.86, treatment 89 of 482 (18.5%), control 80 of 465 (17.2%), odds ratio converted to relative risk, day 28.
risk of death, 26.1% higher, RR 1.26, p = 0.29, treatment 63 of 482 (13.1%), control 48 of 465 (10.3%), odds ratio converted to relative risk, day 14.
risk of 7-point scale, 4.0% higher, OR 1.04, p = 0.76, treatment 487, control 473, day 14, primary outcome, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Self et al., 30 Nov 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 51 authors, study period 28 April, 2020 - 1 June, 2021, average treatment delay 8.0 days, trial NCT04362176 (history) (PassItOn). Contact:
This PaperConv. PlasmaAll
AI generated summary. Current AI models can provide useful summaries for non-experts, but may be inaccurate and have limited ability to analyze larger context such as the entire evidence base for convalescent plasma.

Convalescent plasma was not found to be an effective treatment for adults hospitalized with COVID-19.

This article is about a clinical trial that evaluated the efficacy of convalescent plasma in the treatment of hospitalized COVID-19 patients. Convalescent plasma is plasma that is collected from people who have recovered from COVID-19 and contains antibodies to the virus. The trial was a randomized, double-blind, placebo-controlled trial, which means that the participants were randomly assigned to receive either convalescent plasma or a placebo. Neither the participants nor the researchers knew which group they were in. The primary outcome of the trial was clinical status (disease severity) 14 days following study infusion.

The trial included 974 participants who were hospitalized with COVID-19. The participants were randomly assigned to receive one unit of convalescent plasma (n = 487) or placebo (n = 473). The results showed that there was no difference in clinical status between the two groups at 14 days. This means that convalescent plasma did not improve clinical outcomes in hospitalized COVID-19 patients.

The researchers also evaluated the efficacy of convalescent plasma in a subgroup of participants who did not have endogenous anti-SARS-CoV-2 antibodies (antibodies that the body produces in response to infection with the virus). The results showed that there was no difference in clinical status between the two groups in this subgroup either. This means that convalescent plasma did not improve clinical outcomes in hospitalized COVID-19 patients who did not have endogenous anti-SARS-CoV-2 antibodies.

The researchers concluded that convalescent plasma did not improve clinical outcomes in hospitalized COVID-19 patients. They suggested that future research should focus on identifying patients who are most likely to benefit from convalescent plasma therapy.

Neutralizing COVID-19 Convalescent Plasma in Adults Hospitalized With COVID-19
MD, MPH Wesley H Self, MD Allison P Wheeler, PhD; Thomas G Stewart, MD Harry Schrager, PharmD, BCIDP Jason Mallada, MD Christopher B Thomas, MD Vince D Cataldo, Hollis R O’neal, MD, MPH Nathan I Shapiro, BS Conor Higgins, MD, MPH Adit A Ginde, MD Lakshmi Chauhan, MD Nicholas J Johnson, MD, MPH Daniel J Henning, MD Stuti J Jaiswal, PhD Manoj J Mammen, MD Estelle S Harris, MD Sonal R Pannu, MD Maryrose Laguio-Vila, Wissam El Atrouni, MD Marjolein De Wit, MD Daanish Hoda, MD Claudia S Cohn, MD Carla Mcwilliams, MD Carl Shanholtz, MD Alan E Jones, MD Jay S Raval, MD Simon Mucha, MD, MPH Tina S Ipe, MD Xian Qiao, MD Stephen J Schrantz, MD Aarthi Shenoy, MD Richard D Fremont, BS Eric J Brady, PhD Robert H Carnahan, MD James D Chappell, PhD James E Crowe Jr, MD Mark R Denison, MD Pavlo Gilchuk, PhD Laura J Stevens, MS Rachel E Sutton, MD Isaac Thomsen, MT Sandra M Yoder, BS Amanda J Bistran-Hall, MD Jonathan D Casey, PhD Christopher J Lindsell, MS Li Wang, MBA Jill M Pulley, PhD Jillian P Rhoads, MD Gordon R Bernard, MD Todd W Rice
Chest, doi:10.1016/j.chest.2022.06.029
BACKGROUND: Convalescent plasma has been one of the most common treatments for COVID-19, but most clinical trial data to date have not supported its efficacy. RESEARCH QUESTION: Is rigorously selected COVID-19 convalescent plasma with neutralizing anti-SARS-CoV-2 antibodies an efficacious treatment for adults hospitalized with COVID-19? STUDY DESIGN AND METHODS: This was a multicenter, blinded, placebo-controlled randomized clinical trial among adults hospitalized with SARS-CoV-2 infection and acute respiratory symptoms for < 14 days. Enrolled patients were randomly assigned to receive one unit of COVID-19 convalescent plasma (n ¼ 487) or placebo (n ¼ 473). The primary outcome was clinical status (disease severity) 14 days following study infusion measured with a seven-category ordinal scale ranging from discharged from the hospital with resumption of normal activities (lowest score) to death (highest score). The primary outcome was analyzed with a multivariable ordinal regression model, with an adjusted odds ratio (aOR) < 1.0 indicating more favorable outcomes with convalescent plasma than with placebo. In secondary analyses, trial participants were stratified according to the presence of endogenous anti-SARS-CoV-2 antibodies ("serostatus") at randomization. The trial included 13 secondary efficacy outcomes, including 28-day mortality. RESULTS: Among 974 randomized patients, 960 were included in the primary analysis. Clinical status on the ordinal outcome scale at 14 days did not differ between the convalescent plasma and placebo groups in the overall population (aOR, 1.04; one-seventh support interval [1/7 SI], 0.82-1.33), in patients without endogenous antibodies (aOR, 1.15; 1/7 SI, 0.74-1.80), or in patients with endogenous antibodies (aOR, 0.96; 1/7 SI, 0.72-1.30). None of the 13 secondary efficacy outcomes were different between groups. At 28 days, 89 of 482 (18.5%) patients in the convalescent plasma group and 80 of 465 (17.2%) patients in the placebo group had died (aOR, 1.04; 1/7 SI, 0.69-1.58). INTERPRETATION: Among adults hospitalized with COVID-19, including those seronegative for anti-SARS-CoV-2 antibodies, treatment with convalescent plasma did not improve clinical outcomes.
In each plot, the convalescent plasma group is represented by blue lines and the placebo group by red lines. The top set of lines are Kaplan-Meier survival plots. The bottom set of lines denote the proportion of participants alive and discharged from the hospital. Patient disposition is represented by the three locations within the plot area: dead, represented by the area above the survival lines; alive and still in the hospital, represented by the area between the survival and discharge lines; and discharged from the hospital alive, represented by the area under the discharge lines. The proportion in each disposition state is denoted by the relative height of the region for each day. On study day 1, the vast majority of participants were alive and in the hospital (middle region). Over time, the proportion of participants in the alive and discharged state (lower region) and dead state (upper region) increases, which gives rise to the "funnel" shape of the plot. Participants could move from either in-hospital or discharged states to the dead state. Patients were followed up via medical records and telephone follow-up until 28 days following study infusion. Patients lost to follow-up were included in the risk-set for the portion of days for which disposition was known. A patient was considered discharged from the hospital once discharged from the index hospitalization; re-hospitalizations were not considered in this analysis. In model-based estimates of treatment..
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Late treatment
is less effective
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