Trial reportCirculation2023
Effect of the P-Selectin Inhibitor Crizanlizumab on Survival Free of Organ Support in Patients Hospitalized for COVID-19: A Randomized Controlled Trial.
Trial report in Circulation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04505774 (A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19), which is not on this map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19
Who cites it
13 citing papers in PubMed, 16 citations in OpenAlex.
- Association of Plasma Biomarkers of Immunothrombosis With Death in Patients With Coronavirus Disease 2019 on Extracorporeal Membrane Oxygenation.The Journal of infectious diseases · 2026Article
- The Platelet-Virus Axis in Human Disease.Viruses · 2026Review
- Unraveling the synergy of inflammation and apoptosis in sepsis-induced acute lung injury: Insights and therapeutic perspectives (Review).Molecular medicine reports · 2026Review
- P selectin promotes SARS-CoV-2 interactions with platelets and the endothelium.The Journal of clinical investigation · 2025Article
- Biomarkers of Endothelial Damage and Disease Severity in COVID-19 Patients.Current issues in molecular biology · 2025Article
- Best practices for clinical trials data harmonization and sharing on NHLBI bioData catalyst (BDC) learned from CONNECTS network COVID-19 studies.Journal of clinical and translational science · 2025Article
- Lessons Learned from National Heart, Lung, and Blood Institute Covid-19 Clinical Trials.NEJM evidence · 2024Article
- Clinical Implications of COVID-19-Related Endothelial Dysfunction.JACC. Advances · 2024Review
- New clinical trial design in precision medicine: discovery, development and direction.Signal transduction and targeted therapy · 2024Review
- The statistical design and analysis of pandemic platform trials: Implications for the future.Journal of clinical and translational science · 2024Article
- To Gain Insights into the Pathophysiological Mechanisms of the Thrombo-Inflammatory Process in the Atherosclerotic Plaque.International journal of molecular sciences · 2023Review
- Breakthrough infections after COVID-19 vaccinations do not elicit platelet hyperactivation and are associated with high platelet-lymphocyte and low platelet-neutrophil aggregates.Research and practice in thrombosis and haemostasis · 2023Article
- P-Selectin de-ACTIVation in COVID-19: What Have We Learned?Circulation · 2023Article
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Authors and funding
26 authors at 17 institutions in 4 countries.
Funding
Abstract
backgroundCOVID-19 has been associated with endothelial injury, resultant microvascular inflammation and thrombosis. Activated endothelial cells release and express P-selectin and von Willebrand factor, both of which are elevated in severe COVID-19 and may be implicated in the disease pathophysiology. We hypothesized that crizanlizumab, a humanized monoclonal antibody to P-selectin, would reduce morbidity and death in patients hospitalized for COVID-19.
methodsAn international, adaptive, randomized controlled platform trial, funded by the National Heart, Lung, and Blood Institute, randomly assigned 422 patients hospitalized with COVID-19 with moderate or severe illness to receive either a single infusion of the P-selectin inhibitor crizanlizumab (at a dose of 5 mg/kg) plus standard of care or standard of care alone in an open-label 1:1 ratio. The primary outcome was organ support-free days, evaluated on an ordinal scale consisting of the number of days alive free of organ support through the first 21 days after trial entry.
resultsThe study was stopped for futility by the data safety monitoring committee. Among 421 randomized patients with known 21-day outcomes, 163 patients (77%) randomized to the crizanlizumab plus standard-of-care arm did not require any respiratory or cardiovascular organ support compared with 169 (80%) in the standard-of-care-alone arm. The adjusted odds ratio for the effect of crizanlizumab on organ support-free days was 0.70 (95% CI, 0.43-1.16), where an odds ratio >1 indicates treatment benefit, yielding a posterior probability of futility (odds ratio <1.2) of 98% and a posterior probability of inferiority (odds ratio <1.0) of 91%. Overall, there were 37 deaths (17.5%) in the crizanlizumab arm and 27 deaths (12.8%) in the standard-of-care arm (hazard ratio, 1.33 [95% CrI, 0.85-2.21]; [probability of hazard ratio>1] = 0.879).
conclusionsCrizanlizumab, a P-selectin inhibitor, did not result in improvement in organ support-free days in patients hospitalized with COVID-19. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04505774.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.