Dataset Information

One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients.

ABSTRACT: BACKGROUNDResults of many randomized trials on COVID-19 convalescent plasma (CCP) have been reported, but information on long-term outcome after CCP treatment is limited. The objectives of this extended observation of the randomized CAPSID trial are to assess long-term outcome and disease burden in patients initially treated with or without CCP.METHODSOf 105 randomized patients, 50 participated in the extended observation. Quality of life (QoL) was assessed by questionnaires and a structured interview. CCP donors (n = 113) with asymptomatic to moderate COVID-19 were included as a reference group.RESULTSThe median follow-up of patients was 396 days, and the estimated 1-year survival was 78.7% in the CCP group and 60.2% in the control (P = 0.08). The subgroup treated with a higher cumulative amount of neutralizing antibodies showed a better 1-year survival compared with the control group (91.5% versus 60.2%, P = 0.01). Medical events and QoL assessments showed a consistent trend for better results in the CCP group without reaching statistical significance. There was no difference in the increase in neutralizing antibodies after vaccination between the CCP and control groups.CONCLUSIONThe trial demonstrated a trend toward better outcome in the CCP group without reaching statistical significance. A predefined subgroup analysis showed a significantly better outcome (long-term survival, time to discharge from ICU, and time to hospital discharge) among those who received a higher amount of neutralizing antibodies compared with the control group. A substantial long-term disease burden remains after severe COVID-19.Trial registrationEudraCT 2020-001310-38 and ClinicalTrials.gov NCT04433910.FundingBundesministerium für Gesundheit (German Federal Ministry of Health).

SUBMITTER: Korper S

PROVIDER: S-EPMC9753994 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients.

Körper Sixten S Grüner Beate B Zickler Daniel D Wiesmann Thomas T Wuchter Patrick P Blasczyk Rainer R Zacharowski Kai K Spieth Peter P Tonn Torsten T Rosenberger Peter P Paul Gregor G Pilch Jan J Schwäble Joachim J Bakchoul Tamam T Thiele Thomas T Knörlein Julian J Dollinger Matthias M MM Krebs Jörg J Bentz Martin M Corman Victor M VM Kilalic Dzenan D Schmidtke-Schrezenmeier Gerlinde G Lepper Philipp M PM Ernst Lucas L Wulf Hinnerk H Ulrich Alexandra A Weiss Manfred M Kruse Jan Matthias JM Burkhardt Thomas T Müller Rebecca R Klüter Harald H Schmidt Michael M Jahrsdörfer Bernd B Lotfi Ramin R Rojewski Markus M Appl Thomas T Mayer Benjamin B Schnecko Philipp P Seifried Erhard E Schrezenmeier Hubert H

The Journal of clinical investigation 20221215 24

BACKGROUNDResults of many randomized trials on COVID-19 convalescent plasma (CCP) have been reported, but information on long-term outcome after CCP treatment is limited. The objectives of this extended observation of the randomized CAPSID trial are to assess long-term outcome and disease burden in patients initially treated with or without CCP.METHODSOf 105 randomized patients, 50 participated in the extended observation. Quality of life (QoL) was assessed by questionnaires and a structured int ...[more]

PMID: 36326824

Similar Datasets

Project description:ObjectivesTo determine the profile of cytokines in patients with severe COVID-19 who were enrolled in a trial of COVID-19 convalescent plasma (CCP).MethodsPatients were randomized to receive standard treatment and 3 CCP units or standard treatment alone (CAPSID trial, ClinicalTrials.gov NCT04433910). The primary outcome was a dichotomous composite outcome (survival and no longer severe COVID-19 on day 21). Time to clinical improvement was a key secondary endpoint. The concentrations of 27 cytokines were measured (baseline, day 7). We analyzed the change and the correlation between serum cytokine levels over time in different subgroups and the prediction of outcome in receiver operating characteristics (ROC) analyses and in multivariate models.ResultsThe majority of cytokines showed significant changes from baseline to day 7. Some were strongly correlated amongst each other (at baseline the cluster IL-1ß, IL-2, IL-6, IL-8, G-CSF, MIP-1α, the cluster PDGF-BB, RANTES or the cluster IL-4, IL-17, Eotaxin, bFGF, TNF-α). The correlation matrix substantially changed from baseline to day 7. The heatmaps of the absolute values of the correlation matrix indicated an association of CCP treatment and clinical outcome with the cytokine pattern. Low levels of IP-10, IFN-γ, MCP-1 and IL-1ß on day 0 were predictive of treatment success in a ROC analysis. In multivariate models, low levels of IL-1ß, IFN-γ and MCP-1 on day 0 were significantly associated with both treatment success and shorter time to clinical improvement. Low levels of IP-10, IL-1RA, IL-6, MCP-1 and IFN-γ on day 7 and high levels of IL-9, PDGF and RANTES on day 7 were predictive of treatment success in ROC analyses. Low levels of IP-10, MCP-1 and high levels of RANTES, on day 7 were associated with both treatment success and shorter time to clinical improvement in multivariate models.ConclusionThis analysis demonstrates a considerable dynamic of cytokines over time, which is influenced by both treatment and clinical course of COVID-19. Levels of IL-1ß and MCP-1 at baseline and MCP-1, IP-10 and RANTES on day 7 were associated with a favorable outcome across several endpoints. These cytokines should be included in future trials for further evaluation as predictive factors.

Project description:BackgroundCompared with traditional tendon repair teaching methods, using a virtual reality (VR) simulator to teach tendon suturing can significantly improve medical students' exercise time, operation flow and operation knowledge. At present, the purpose of this study is to explore the long-term influence of VR simulator teaching on the practice performance of medical students.MethodThis is a one-year long-term follow-up study of a randomized controlled study. A total of 117 participants who completed the initial study were invited to participate in the follow-up study. Participants in the VR group and the control group were required to complete a questionnaire developed by the authors and the teachers in the teaching and research department and to provide their surgical internship scores and Objective Structure Clinical Examination(OSCE) graduation scores.ResultsOf the 117 invitees, 108 completed the follow-up. The answers to the questions about career choice and study habits were more positive in the VR group than in the control group (p < 0.05). The total score for clinical practice in the VR group was better than that in the control group, and the difference was statistically significant (p < 0.05). In the OSCE examination, the scores for physical examination, suturing and knotting and image reading were higher in the VR group than in the control group, and the difference was statistically significant (p < 0.05).ConclusionThe results of the one-year long-term follow-up indicated that compared with medical students experiencing the traditional teaching mode, those experiencing the VR teaching mode had more determined career pursuit and active willingness to learn, better evaluations from teachers in the process of surgical clinical practice, and better scores in physical examination, suturing and knotting and image reading in the OSCE examination. In the study of nonlinear dynamics to cultivate a good learning model for medical students, the VR teaching model is expected to become an effective and stable initial sensitive element.Trial registrationChinese Clinical Trial Registry(25/05/2021, ChiCTR2100046648); http://www.chictr.org.cn/hvshowproject.aspx?id=90180 .

Dataset Information

One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients.

Publications

One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets