Trial reportJAMA network open2021
Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial.
Trial report in JAMA network open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04716556 (TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2), which is not on this map. Cited by 41 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial
Who cites it
41 citing papers in PubMed, 9 syntheses or guidelines pooled it.
- Convalescent plasma and all-cause mortality of COVID-19 patients: systematic review and meta-analysis.Scientific reports · 2023Pooled it
- Effect of convalescent plasma transfusion on outcomes of coronavirus disease 2019: a meta-analysis with trial sequential analysis.Journal of anesthesia · 2023Pooled it
- Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023Pooled it
- Convalescent Plasma Therapy for COVID-19: A Systematic Review and Meta-Analysis on Randomized Controlled Trials.Viruses · 2023Pooled it
- Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023Pooled it
- Pooled it
- Clinical Practice Guidelines From the Association for the Advancement of Blood and Biotherapies (AABB): COVID-19 Convalescent Plasma.Annals of internal medicine · 2022Guideline
- Efficacy and Safety of COVID-19 Treatment Using Convalescent Plasma Transfusion: Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.International journal of environmental research and public health · 2022Pooled it
- The efficiency of convalescent plasma in COVID-19 patients: A systematic review and meta-analysis of randomized controlled clinical trials.Frontiers in immunology · 2022Pooled it
- Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial.BMC infectious diseases · 2022Trial
- Trial
- Evidence for the Efficacy of COVID-19 Convalescent Plasma.Current topics in microbiology and immunology · 2025Review
- Estimates of actual and potential lives saved in the United States from the use of COVID-19 convalescent plasma.Proceedings of the National Academy of Sciences of the United States of America · 2024Article
- Avoided and Avoidable Deaths with the Use of COVID-19 Convalescent Plasma in Italy during the First Two Years of Pandemic.Life (Basel, Switzerland) · 2024Article
- Exploring Study Design Foibles in Randomized Controlled Trials on Convalescent Plasma in Hospitalized COVID-19 Patients.Life (Basel, Switzerland) · 2024Review
- Safety and Efficacy of Convalescent Plasma Combined with Other Pharmaceutical Agents for Treatment of COVID-19 in Hospitalized Patients: A Systematic Review and Meta-Analysis.Diseases (Basel, Switzerland) · 2024Review
- Hyperimmune Plasma and Immunoglobulins against COVID-19: A Narrative Review.Life (Basel, Switzerland) · 2024Review
- The Role of Convalescent Plasma in COVID-19: A Conclusive Post-Pandemic Review.Life (Basel, Switzerland) · 2023Article
- Rates Among Hospitalized Patients With COVID-19 Treated With Convalescent Plasma: A Systematic Review and Meta-Analysis.Mayo Clinic proceedings. Innovations, quality & outcomes · 2023Article
- Efficacy of Convalescent Plasma to Treat Long-Standing COVID-19 in Patients with B-Cell Depletion.Life (Basel, Switzerland) · 2023Article
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
53 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Importance: Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia. Objective: To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia. Design, Setting, and Participants: This prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible. Interventions: Patients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations. Main Outcomes and Measures: The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio <150 mm Hg) or death within 30 days from randomization. Results: Of the 487 randomized patients (241 to CP plus ST; 246 to ST alone), 312 (64.1%) were men; the median (IQR) age was 64 (54.0-74.0) years. The modified intention-to-treat population included 473 patients. The primary end point occurred in 59 of 231 patients (25.5%) treated with CP and ST and in 67 of 239 patients (28.0%) who received ST (odds ratio, 0.88; 95% CI, 0.59-1.33; P = .54). Adverse events occurred more frequently in the CP group (12 of 241 [5.0%]) compared with the control group (4 of 246 [1.6%]; P = .04). Conclusions and Relevance: In patients with moderate to severe COVID-19 pneumonia, high-titer anti-SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days. Trial Registration: ClinicalTrials.gov Identifier: NCT04716556.
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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 OpenQuestion graph.