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  1. Article ; Online: Neutralizing activity to SARS-CoV-2 of convalescent and control plasma used in a randomized controlled trial.

    Freedenberg, Alex T / Pan, Chun-Hao / Diehl, William E / Romeiser, Jamie L / Hwang, Ga-Ram / Leiton, Cindy V / Muecksch, Frauke / Shroyer, Kenneth R / Bennett-Guerrero, Elliott

    Transfusion

    2021  Volume 61, Issue 5, Page(s) 1363–1369

    Abstract: Background: There are limited data on the neutralizing activity of convalescent plasma (CP) administered in randomized controlled trials (RCT) of COVID-19 infection.: Study design and methods: As part of an RCT, CP was collected per FDA guidelines ... ...

    Abstract Background: There are limited data on the neutralizing activity of convalescent plasma (CP) administered in randomized controlled trials (RCT) of COVID-19 infection.
    Study design and methods: As part of an RCT, CP was collected per FDA guidelines from individuals recovered from COVID-19 infection. CP donors had to have ≥145 optical density (OD) units (ideal target ≥300) using a semiquantitative, immunochromatographic test for IgG antibody to the nucleocapsid protein (NP) of SARS-CoV-2 (typical range 0-500 OD units). A random subset of samples [14 control plasma, 12 CP "medium-anti-NP" (145-299 OD units), and 13 CP "high" anti-NP (≥300 OD units)] were tested for neutralizing antibodies using an established viral luciferase antibody inhibition assay to detect the infection of SARS-CoV-2 pseudovirus that encoded spike protein (SARS2-S
    Results: The uptake of SARS-CoV-2 pseudovirus by 293T
    Discussion: Plasma from donors screened using an immunochromatographic test for IgG antibody to SARS-CoV-2 NP exhibited neutralizing activity meeting FDA's minimum standard in all randomly selected COVID-19 CP units.
    MeSH term(s) Adult ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; Blood Donors ; COVID-19/blood ; Convalescence ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; SARS-CoV-2/metabolism
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral
    Language English
    Publishing date 2021-02-19
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.16283
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 284: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Impact of serological and PCR testing requirements on the selection of COVID-19 convalescent plasma donors.

    Carter, Jason A / Freedenberg, Alex T / Romeiser, Jamie L / Talbot, Lillian R / Browne, Nicholas J / Cosgrove, Megan E / Shevik, Margaret E / Generale, Laura M / Rago, Molly G / Caravella, Giuseppina A / Ahmed, Tahmeena / Mamone, Linda J / Bennett-Guerrero, Elliott

    Transfusion

    2021  Volume 61, Issue 5, Page(s) 1461–1470

    Abstract: Background: Convalescent plasma is undergoing randomized trials as a potential therapeutic option for COVID-19 infection. Little empirical evidence exists regarding the determination of donor eligibility and experiences with donor selection.: Study ... ...

    Abstract Background: Convalescent plasma is undergoing randomized trials as a potential therapeutic option for COVID-19 infection. Little empirical evidence exists regarding the determination of donor eligibility and experiences with donor selection.
    Study design and methods: This prospective study was conducted at a tertiary care hospital in New York to select plasma donors for a randomized, double-blind, controlled convalescent plasma trial. Clearance for donation required successful completion of an online questionnaire and an in-person screening visit, which included (a) completion of a Donor Health Questionnaire (DHQ), (b) Immunoglobulin G (IgG) antibody testing using an immunochromatographic anti- severe acute respiratory coronavirus 2 (SARS-CoV-2) test, (c) Polymerase chain reaction (PCR) testing if <28 days from symptom resolution, and (d) routine blood bank testing.
    Results: After receiving 3093 online questionnaires, 521 individuals presented for in-person screening visits, with 40.1% (n = 209) fully qualifying. Subjects (n = 312) failed to progress due to the following reasons: disqualifying answer from DHQ (n = 30, 9.6%), insufficient antibodies (n = 198, 63.5%), persistent positive PCR tests (n = 14, 4.5%), and blood donation testing labs (n = 70, 22.4%). Importantly, 24.6% and 11.1% of potential donors who reported having PCR-diagnosed infection had low or undetectable SARS-CoV-2 antibody levels, respectively. Surprisingly, 62.9% (56/89) of subjects had positive PCR tests 14-27 days after symptom resolution, with 13 individuals continuing to be PCR positive after 27 days.
    Conclusion: It is feasible for a single site to fully qualify a large number of convalescent plasma donors in a short period of time. Among otherwise qualified convalescent plasma donors, we found high rates of low or undetectable antibody levels and many individuals with persistently positive PCR tests.
    MeSH term(s) Adult ; Blood Donors ; COVID-19/blood ; COVID-19 Nucleic Acid Testing ; COVID-19 Serological Testing ; Convalescence ; Donor Selection ; Female ; Humans ; Male ; Middle Aged ; Reverse Transcriptase Polymerase Chain Reaction
    Language English
    Publishing date 2021-02-08
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.16293
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 284: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article ; Online: Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial.

    Bennett-Guerrero, Elliott / Romeiser, Jamie L / Talbot, Lillian R / Ahmed, Tahmeena / Mamone, Linda J / Singh, Sunitha M / Hearing, Janet C / Salman, Huda / Holiprosad, Dishaw D / Freedenberg, Alex T / Carter, Jason A / Browne, Nicholas J / Cosgrove, Megan E / Shevik, Margaret E / Generale, Laura M / Andrew, Margaret A / Nachman, Sharon / Fries, Bettina C

    Critical care medicine

    2021  Volume 49, Issue 7, Page(s) 1015–1025

    Abstract: Objectives: Four peer-reviewed publications have reported results from randomized controlled trials of convalescent plasma for coronavirus disease 2019 infection; none were conducted in the United States nor used standard plasma as a comparator. To ... ...

    Abstract Objectives: Four peer-reviewed publications have reported results from randomized controlled trials of convalescent plasma for coronavirus disease 2019 infection; none were conducted in the United States nor used standard plasma as a comparator. To determine if administration of convalescent plasma to patients with coronavirus disease 2019 increases antibodies to severe acute respiratory syndrome coronavirus 2 and improves outcome.
    Design: Double-blind randomized controlled trial.
    Setting: Hospital in New York.
    Patients: Patients with polymerase chain reaction documented coronavirus disease 2019 infection.
    Interventions: Patients were randomized (4:1) to receive 2 U of convalescent plasma versus standard plasma. Antibodies to severe acute respiratory syndrome coronavirus 2 were measured in plasma units and in trial recipients.
    Measurements and main results: Enrollment was terminated after emergency use authorization was granted for convalescent plasma. Seventy-four patients were randomized. At baseline, mean (sd) Acute Physiology and Chronic Health Evaluation II score (23.4 [5.6] and 22.5 [6.6]), percent of patients intubated (19% and 20%), and median (interquartile range) days from symptom onset to randomization of 9 (6-18) and 9 (6-15), were similar in the convalescent plasma versus standard plasma arms, respectively. Convalescent plasma had high neutralizing activity (median [interquartile range] titer 1:526 [1:359-1:786]) and its administration increased antibodies to severe acute respiratory syndrome coronavirus 2 by 14.4%, whereas standard plasma administration led to an 8.6% decrease (p = 0.005). No difference was observed for ventilator-free days through 28 days (primary study endpoint): median (interquartile range) of 28 (2-28) versus 28 (0-28; p = 0.86) for the convalescent plasma and standard plasma groups, respectively. A greater than or equal to 2 point improvement in the World Health Organization scale was achieved by 20% of subjects in both arms (p = 0.99). All-cause mortality through 90 days was numerically lower in the convalescent plasma versus standard plasma groups (27% vs 33%; p = 0.63) but did not achieve statistical significance. A key prespecified subgroup analysis of time to death in patients who were intubated at baseline was statistically significant; however, sample size numbers were small.
    Conclusions: Administration of convalescent plasma to hospitalized patients with coronavirus disease 2019 infection increased antibodies to severe acute respiratory syndrome coronavirus disease 2 but was not associated with improved outcome.
    MeSH term(s) Aged ; Antibodies, Neutralizing/blood ; COVID-19/therapy ; Double-Blind Method ; Female ; Humans ; Immunization, Passive ; Immunoglobulin G/blood ; Immunoglobulin M/blood ; Male ; Middle Aged ; New York/epidemiology ; SARS-CoV-2 ; Treatment Outcome ; COVID-19 Serotherapy
    Chemical Substances Antibodies, Neutralizing ; Immunoglobulin G ; Immunoglobulin M
    Language English
    Publishing date 2021-04-22
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 197890-1
    ISSN 1530-0293 ; 0090-3493
    ISSN (online) 1530-0293
    ISSN 0090-3493
    DOI 10.1097/CCM.0000000000005066
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1261: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

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