Trial reportEBioMedicine2025
Early, very high-titre convalescent plasma therapy in clinically vulnerable individuals with mild COVID-19: an international, randomised, open-label trial.
Trial report in EBioMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05271929 (A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals With Mild COVID-19), which is not on this map. Cited by 14 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 Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals With Mild COVID-19
Who cites it
14 citing papers in PubMed.
- SARS-CoV-2 convalescent plasma for the controlled clinical trial "COVIC-19": Experience from collection of very high-titer plasma from superimmunized individuals.Transfusion · 2025Trial
- Patient and donor antibody profiles in early COVID-19 convalescent plasma therapy in the COnV-ert trial.Frontiers in immunology · 2025Trial
- Convalescent plasma for persistent symptomatic COVID-19 infection in immune-suppressed patients - a case series.Infectious medicine · 2026Article
- CONVICTION-CHIK study on the effect of convalescent plasma for mother-to-child Chikungunya infection: protocol for a multicentre, open label, single-arm, phase II trial.BMC pregnancy and childbirth · 2026Article
- The Value of Convalescent Plasma Therapy as a Strategy to Decrease Hospitalization in COVID-19 Patients: A Randomized Clinical Trial.Acta medica Philippina · 2026Article
- A Novel Adaptive Platform for Rapid, Simple Flow-Based Antibody Detection Devices Predicts NAb Levels to SARS-CoV-2.Pathogens & immunity · 2026Article
- COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval.Expert review of anti-infective therapy · 2026Review
- Intelligent Patient Management in Viral Diseases: An Integrated Regression Model and Multi-Criteria Decision-Making Approach to Convalescent Plasma Transfusion.Healthcare (Basel, Switzerland) · 2025Article
- Impaired serum neutralization and death in Omicron-infected critically ill patients: insights from the French SEVARVIR prospective, multicenter cohort study.Intensive care medicine experimental · 2025Article
- Article
- Article
- Efficacy of convalescent plasma therapy in improving survival in non-immunized COVID-19 patients.Virology journal · 2025Article
- Early combined therapy for COVID-19 in immunocompromised patients: a promising approach against viral persistence and drug resistance.BMC infectious diseases · 2025Review
- The Emergence of Escape Mutations in COVID-19 Following Anti-Spike Monoclonal Antibody Treatment: How Do We Tackle It?Infection and drug resistance · 2025Review
Corrections and comments
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Authors and funding
33 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCOVID-19 convalescent plasma (CCP) is a treatment option for COVID-19. This study investigated the safety and efficacy of early, very high-titre CCP in immunocompromised individuals with mild COVID-19.
methodsThis randomised, controlled, open-label trial assessed CCP in immunocompromised patients (n = 120) with mild COVID-19 in 10 clinical trial centres across Germany, France, and the Netherlands. Patients were randomised 1:1 to receive either standard of care (SoC) alone (SoC group) or SoC and 2 units of CCP. Most patients (89.7%) had received ≥3 SARS-CoV-2 vaccinations. The primary endpoint was hospitalisation for progressive COVID-19 symptoms or death by day 28 after randomisation, analysed on a modified intention-to-treat basis (117 patients). The safety analysis included the full analysis set. The trial is registered with EudraCT 2021-006621-22, and ClinicalTrials.gov, NCT05271929.
findingsBetween April 11, 2022 and November 27, 2023, 120 patients were enrolled. Patients in the CCP group received a median of 559 ml CCP from convalescent, vaccinated donors with very high levels of SARS-CoV-2 antibodies (median 81,810 IU/ml) at a median 4 days after symptom onset. The primary outcome occurred in 5/58 patients (8.6%) in the SoC group and in 0/59 patients (0%) in the CCP group, difference -8.6% (95% confidence interval of difference -19% to -0.80%; p-value 0.027; Fisher's exact test). The course of SARS-CoV-2 antibodies in the patients demonstrated a passive transfer of antibodies by the CCP, in particular neutralising effects against new SARS-CoV-2 variants. Whole genome sequencing of SARS-CoV-2 in patients during follow-up showed significant intra-host viral evolution, but without differences between groups. CCP was well tolerated.
interpretationEarly administration of high-titre CCP can prevent hospitalisation or death in immunocompromised patients with mild COVID-19.
fundingSupport-e project (European Union's Horizon 2020 Programme), German Federal Ministry of Education and Research, ZonMw, the Netherlands Organisation for Health Research and Development.
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