Dataset Information

Convalescent plasma therapy for coronavirus disease 2019 in ambulatory versus hospitalized patients: Efficacy and risk of thromboembolism.

ABSTRACT:

Background

Although early evidence concluded a lack of clinical benefit of convalescent plasma therapy (CPT) in COVID-19 management, recent trials have demonstrated the therapeutic potential of CPT in ambulatory care. CPT may also potentiate thromboembolic events, given the presence of coagulation factors and the prothrombotic state of COVID-19.

Objectives

The present study aimed to assess and compare the clinical efficacy and the risk of venous thromboembolism (VTE)/arterial thromboembolism (ATE) of CPT in ambulatory versus hospitalized patients with COVID-19.

Methods

MEDLINE, Embase, and Cochrane CENTRAL were searched from December 2019 to December 2022 for randomized controlled trials that investigated the use of CPT against placebo or standard of care in adult patients with COVID-19. The primary outcome was nonmortality disease progression. Secondary outcomes include VTE, ATE, 28-day mortality, clinical improvement, length of hospitalization, sepsis/fever, and major adverse cardiovascular events.

Results

Twenty randomized controlled trials, with 21,340 patients, were included. CPT significantly reduced nonmortality disease progression in ambulatory patients (odds ratio [OR], 0.72; 95% CI, 0.56-0.92; P = .009) but not in hospitalized patients (OR, 1.03; 95% CI, 0.94-1.12; P = .58). The risk of VTE and ATE did not differ between the CPT and the control group (OR, 1.16; 95% CI, 0.82-1.66; P = .40; and OR, 1.01; 95% CI, 0.37-2.79; P = .98, respectively). No conclusive differences between CPT and control groups were noted in 28-day mortality, clinical improvement, length of hospitalization, risk of sepsis/fever, and major adverse cardiovascular events.

Conclusion

In conclusion, treatment of COVID-19 with CPT prevents the progression of COVID-19 in the ambulatory care. It is not associated with an increased risk of VTE, ATE, or other adverse events.

SUBMITTER: Li PY

PROVIDER: S-EPMC9901222 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Convalescent plasma therapy for coronavirus disease 2019 in ambulatory versus hospitalized patients: Efficacy and risk of thromboembolism.

Li Pei Ye PY Yu Philip P Li Allen A Khalid Faran F Laureano Marissa Liselle ML Crowther Mark Andrew MA

Research and practice in thrombosis and haemostasis 20230206 2

<h4>Background</h4>Although early evidence concluded a lack of clinical benefit of convalescent plasma therapy (CPT) in COVID-19 management, recent trials have demonstrated the therapeutic potential of CPT in ambulatory care. CPT may also potentiate thromboembolic events, given the presence of coagulation factors and the prothrombotic state of COVID-19.<h4>Objectives</h4>The present study aimed to assess and compare the clinical efficacy and the risk of venous thromboembolism (VTE)/arterial thro ...[more]

PMID: 36777286

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Project description:ObjectivesFour peer-reviewed publications have reported results from randomized controlled trials of convalescent plasma for coronavirus disease 2019 infection; none were conducted in the United States nor used standard plasma as a comparator. To determine if administration of convalescent plasma to patients with coronavirus disease 2019 increases antibodies to severe acute respiratory syndrome coronavirus 2 and improves outcome.DesignDouble-blind randomized controlled trial.SettingHospital in New York.PatientsPatients with polymerase chain reaction documented coronavirus disease 2019 infection.InterventionsPatients were randomized (4:1) to receive 2 U of convalescent plasma versus standard plasma. Antibodies to severe acute respiratory syndrome coronavirus 2 were measured in plasma units and in trial recipients.Measurements and main resultsEnrollment was terminated after emergency use authorization was granted for convalescent plasma. Seventy-four patients were randomized. At baseline, mean (sd) Acute Physiology and Chronic Health Evaluation II score (23.4 [5.6] and 22.5 [6.6]), percent of patients intubated (19% and 20%), and median (interquartile range) days from symptom onset to randomization of 9 (6-18) and 9 (6-15), were similar in the convalescent plasma versus standard plasma arms, respectively. Convalescent plasma had high neutralizing activity (median [interquartile range] titer 1:526 [1:359-1:786]) and its administration increased antibodies to severe acute respiratory syndrome coronavirus 2 by 14.4%, whereas standard plasma administration led to an 8.6% decrease (p = 0.005). No difference was observed for ventilator-free days through 28 days (primary study endpoint): median (interquartile range) of 28 (2-28) versus 28 (0-28; p = 0.86) for the convalescent plasma and standard plasma groups, respectively. A greater than or equal to 2 point improvement in the World Health Organization scale was achieved by 20% of subjects in both arms (p = 0.99). All-cause mortality through 90 days was numerically lower in the convalescent plasma versus standard plasma groups (27% vs 33%; p = 0.63) but did not achieve statistical significance. A key prespecified subgroup analysis of time to death in patients who were intubated at baseline was statistically significant; however, sample size numbers were small.ConclusionsAdministration of convalescent plasma to hospitalized patients with coronavirus disease 2019 infection increased antibodies to severe acute respiratory syndrome coronavirus disease 2 but was not associated with improved outcome.

Project description:BackgroundThe efficacy of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) is primarily ascribed as a source of neutralizing anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies. However, the composition of other immune components in CCP and their potential roles remain largely unexplored. This study aimed to describe the composition and concentrations of plasma cytokines and chemokines in eligible CCP donors.MethodsA cross-sectional study was conducted among 20 prepandemic healthy blood donors without SARS-CoV-2 infection and 140 eligible CCP donors with confirmed SARS-CoV-2 infection. Electrochemiluminescence detection-based multiplexed sandwich immunoassays were used to quantify plasma cytokine and chemokine concentrations (n = 35 analytes). A SARS-CoV-2 microneutralization assay was also performed. Differences in the percentage of detection and distribution of cytokine and chemokine concentrations were examined by categorical groups using Fisher's exact and Wilcoxon rank-sum tests, respectively.ResultsAmong CCP donors (n = 140), the median time since molecular diagnosis of SARS-CoV-2 was 44 days (interquartile range = 38-50) and 9% (n = 12) were hospitalized due to COVID-19. Compared with healthy blood donor controls, CCP donors had significantly higher plasma levels of interferon (IFN)-γ, interleukin (IL)-10, IL-15, IL-21, and macrophage-inflammatory protein-1, but lower levels of IL-1RA, IL-8, IL-16, and vascular endothelial growth factor-A (P < .0014). The distributions of plasma levels of IL-8, IL-15, and IFN-inducible protein-10 were significantly higher among CCP donors with high (≥160) versus low (<40) anti-SARS-CoV-2 neutralizing antibody titers (P < .0014). The median levels of IL-6 were significantly higher among CCP donors who were hospitalized versus nonhospitalized (P < .0014).ConclusionsHeterogeneity in cytokine and chemokine composition of CCP suggests there is a different inflammatory state among the CCP donors compared with SARS-CoV-2 naive, healthy blood donors.

Dataset Information

Convalescent plasma therapy for coronavirus disease 2019 in ambulatory versus hospitalized patients: Efficacy and risk of thromboembolism.

Background

Objectives

Methods

Results

Conclusion

Publications

Convalescent plasma therapy for coronavirus disease 2019 in ambulatory versus hospitalized patients: Efficacy and risk of thromboembolism.

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