Evidence map›Paper›PMID 34473652›Full record

Trial reportThe Journal of clinical investigation2021

A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia.

Cristina Avendaño-Solá, Antonio Ramos-Martínez, Elena Muñez-Rubio, Belen Ruiz-Antorán, Rosa Malo de Molina, Ferran Torres, Ana Fernández-Cruz, Jorge Calderón-Parra, Concepcion Payares-Herrera, Alberto Díaz de Santiago and 28 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04345523 (Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients), which is not on this map. Cited by 66 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 9 pooled it
7.0field-weighted citation impact, top 2% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04345523 phase2completednot on this map

Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients

TypeinterventionalSponsorCristina Avendaño SoláRan2020 to 2021Enrolled350ConditionsCOVID-19ArmsBlood and derivatives., Standard of Care
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 9 syntheses or guidelines pooled it, 109 citations in OpenAlex.

  1. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
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  4. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
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  10. Efficacy of convalescent plasma therapy for COVID-19 in Japan: An open-label, randomized, controlled trial.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2023
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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

38 authors at 16 institutions in 5 countries.

Cristina Avendaño-SoláClinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, SCReN Clinical Trials Platform, Madrid, Spain.
Antonio Ramos-MartínezInfectious Diseases Unit, Department of Internal Medicine and.
Elena Muñez-RubioInfectious Diseases Unit, Department of Internal Medicine and.
Belen Ruiz-AntoránClinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, SCReN Clinical Trials Platform, Madrid, Spain.
Rosa Malo de MolinaRespiratory Medicine Service, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
Ferran TorresClinical Pharmacology Department, Hospital Clinic Barcelona, Barcelona, Spain.
Ana Fernández-CruzInfectious Diseases Unit, Department of Internal Medicine and.
Jorge Calderón-ParraInfectious Diseases Unit, Department of Internal Medicine and.
Concepcion Payares-HerreraClinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, SCReN Clinical Trials Platform, Madrid, Spain.
Alberto Díaz de SantiagoInfectious Diseases Unit, Department of Internal Medicine and.
Irene Romera-MartínezDepartment of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
Ilduara PintosInfectious Diseases Unit, Department of Internal Medicine and.
Jaime Lora-TamayoDepartment of Internal Medicine, Instituto de Investigación "i+12" and.
Mikel Mancheño-LosaDepartment of Internal Medicine, Instituto de Investigación "i+12" and.
Maria L PacielloDepartment of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain.
A L Martínez-GonzálezDepartment of Internal Medicine, and.
Julia Vidán-EstévezDepartment of Hematology, Complejo Asistencial Universitario de León, León, Spain.
Maria J Nuñez-OrantosInfectious Diseases Unit, Department of Internal Medicine and.
Maria Isabel Saez-SerranoHematology Service, Hospital Universitario Clinico San Carlos, Madrid, Spain.
Maria L Porras-LealInfectious Diseases Unit, Department of Internal Medicine, and.
Maria C Jarilla-FernándezHematology and Hemotherapy Service, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
Paula VillaresDepartment of Internal Medicine, Hospital Universitario HM Sanchinarro, Madrid, Spain.
Jaime Pérez de OteyzaDepartment of Hematology, Hospital Universitario HM Sanchinarro, Universidad CEU San Pablo Madrid, Spain.
Ascension Ramos-GarridoBlood Transfusion Military Center, Ministry of Defense, Spain.
Lydia BlancoCentro de Hemoterapia y Hemodonación de Castilla y León, Valladolid, Spain.
Maria E Madrigal-SánchezCentro de Transfusión de Ciudad Real, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
Martin Rubio-BatllésCentro de Transfusión de Albacete y Cuenca, Albacete, Spain.
Ana Velasco-IglesiasSpanish Clinical Research Network (ISCIII), IIS -Hospital Puerta de Hierro-Segovia de Arana, Madrid, Spain.
José R Paño-PardoDivision of Infectious Diseases and.
J A Moreno-ChulillaDivision of Hematology, Hospital Clínico Universitario Zaragoza-IIS Aragón, Zaragoza, Spain.
Eduardo Muñiz-DíazInmunohematology Division, Banc de Sang i Teixits, Barcelona, Spain.
Inmaculada Casas-FlechaRespiratory Virus and Influenza Unit and.
Mayte Pérez-OlmedaLaboratorio de Serología, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Madrid, Spain.
Javier García-PérezAIDS Immunopathogenesis Unit, Instituto de Salud Carlos III, Madrid, Spain.
Jose AlcamíAIDS Immunopathogenesis Unit, Instituto de Salud Carlos III, Madrid, Spain.
Jose L BuenoDepartment of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
Rafael F DuarteDepartment of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
ConPlas-19 Study Group
Hospital Universitario Puerta de Hierro Majadahonda · ESInstituto de Salud Carlos III · ESHospital General Universitario de Ciudad Real · ESHospital Universitario HM Sanchinarro · ESBanc de Sang i Teixits · ESCentro Regional de Hemodonación · ESComplejo Asistencial Universitario de Palencia · ESHospital Clínico San Carlos · ESHospital Clínico Universitario Lozano Blesa · ESHospital General Universitario de Albacete · ESHospital Universitario 12 De Octubre · ESMinistry of Defence · GBNational Influenza Center · MNOffice of Infectious Diseases · USSpanish Clinical Research Network · ESUniversitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUNDPassive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19. Evidence from controlled clinical trials is inconclusive.METHODSWe conducted a randomized, open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high-flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (noninvasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7 (death) at 14 days. Primary analysis was performed in the intention-to-treat population.RESULTSBetween April 4, 2020, and February 5, 2021, 350 patients were randomly assigned to either CP (n = 179) or SOC (n = 171). At 14 days, proportion of patients in categories 5, 6, or 7 was 11.7% in the CP group versus 16.4% in the control group (P = 0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in the CP group versus 17.0% in the control group (P = 0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95% CI 0.19-1.14, log-rank P = 0.087).CONCLUSIONCP showed a significant benefit in preventing progression to noninvasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO, or death at 28 days. The effect on the predefined primary endpoint at 14 days and the effect on overall survival were not statistically significant.TRIAL REGISTRATIONClinicaltrials.gov, NCT04345523.FUNDINGGovernment of Spain, Instituto de Salud Carlos III.

Indexed as

SARS-CoV-2AgedCombined Modality TherapyCOVID-19COVID-19 SerotherapyDisease ProgressionFemaleHospitalizationHumansImmunization, PassiveKaplan-Meier EstimateMaleMiddle AgedOdds RatioPandemicsSpainCOVID-19Immunotherapy

Identifiers

PMID34473652
PMCPMC8516461
OpenAlexW3198314694

What OpenQuestion holds

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Registered trials

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.