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  1. Article ; Online: Factors related to the development of high antibody titres against SARS-CoV-2 in convalescent plasma donors from the ConPlas-19 trial.

    Romera Martínez, Irene / Avendaño-Solá, Cristina / Villegas Da Ros, Carolina / Bosch Llobet, Alba / García Erce, José Antonio / González Fraile, María Isabel / Guerra Domínguez, Luisa / Vicuña Andrés, Isabel / Anguita Velasco, Javier / González Rodríguez, Victoria Paz / Contreras, Enric / Urcelay Uranga, Sabin / Pajares Herraiz, Ángel Luis / Jimenez-Marco, Teresa / Ojea Pérez, Ana María / Arroyo Rodríguez, José Luis / Pérez-Olmeda, Mayte / Ramos-Martínez, Antonio / Velasco-Iglesias, Ana /
    Bueno Cabrera, José Luis / Duarte, Rafael F

    Vox sanguinis

    2023  Volume 119, Issue 1, Page(s) 27–33

    Abstract: Background and objectives: The efficacy of COVID-19 convalescent plasma (CP) associates with high titres of antibodies. ConPlas-19 clinical trial showed that CP reduces the risk of progression to severe COVID-19 at 28 days. Here, we aim to study ConPlas- ...

    Abstract Background and objectives: The efficacy of COVID-19 convalescent plasma (CP) associates with high titres of antibodies. ConPlas-19 clinical trial showed that CP reduces the risk of progression to severe COVID-19 at 28 days. Here, we aim to study ConPlas-19 donors and characteristics that associate with high anti-SARS-CoV-2 antibody levels.
    Materials and methods: Four-hundred donors were enrolled in ConPlas-19. The presence and titres of anti-SARS-CoV-2 antibodies were evaluated by EUROIMMUN anti-SARS-CoV-2 S1 IgG ELISA.
    Results: A majority of 80.3% of ConPlas-19 donor candidates had positive EUROIMMUN test results (ratio ≥1.1), and of these, 51.4% had high antibody titres (ratio ≥3.5). Antibody levels decline over time, but nevertheless, out of 37 donors tested for an intended second CP donation, over 90% were still EUROIMMUN positive, and nearly 75% of those with high titres maintained high titres in the second sample. Donors with a greater probability of developing high titres of anti-SARS-CoV-2 antibodies include those older than 40 years of age (RR 2.06; 95% CI 1.24-3.42), with more than 7 days of COVID-19 symptoms (RR 1.89; 95% CI 1.05-3.43) and collected within 4 months from infection (RR 2.61; 95% CI 1.16-5.90). Male donors had a trend towards higher titres compared with women (RR 1.67; 95% CI 0.91-3.06).
    Conclusion: SARS-CoV-2 CP candidate donors' age, duration of COVID-19 symptoms and time from infection to donation associate with the collection of CP with high antibody levels. Beyond COVID-19, these data are relevant to inform decisions to optimize the CP donor selection process in potential future outbreaks.
    MeSH term(s) Female ; Humans ; Male ; Antibodies, Neutralizing ; Antibodies, Viral ; Blood Donors ; COVID-19/therapy ; COVID-19 Serotherapy ; Immunization, Passive/methods ; Immunoglobulin G ; SARS-CoV-2 ; Clinical Trials as Topic
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral ; Immunoglobulin G
    Language English
    Publishing date 2023-11-20
    Publishing country England
    Document type Journal Article
    ZDB-ID 80313-3
    ISSN 1423-0410 ; 0042-9007
    ISSN (online) 1423-0410
    ISSN 0042-9007
    DOI 10.1111/vox.13561
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Pathogen reduction with methylene blue does not have an impact on the clinical effectiveness of COVID-19 convalescent plasma.

    Romera Martínez, Irene / Bueno Cabrera, José Luis / Domingo-Morera, José María / López Aguilar, Juan Carlos / Villegas Da Ros, Carolina / García Erce, José Antonio / Sáez Serrano, Isabel / Flores Ballester, Elena / Maglio, Laura Analía / Arbona Castaño, Cristina / Sola Lapeña, Carlos / Guerra Domínguez, Luisa / Berberana Fernández, Margarita / Madrigal Sánchez, María Elena / Rubio Batllés, Martín / Pérez-Olmeda, Mayte / Ramos-Martínez, Antonio / Velasco-Iglesias, Ana / Avendaño-Solá, Cristina /
    Duarte, Rafael F

    Vox sanguinis

    2023  Volume 118, Issue 4, Page(s) 296–300

    Abstract: Background and objectives: There is a concern about a possible deleterious effect of pathogen reduction (PR) with methylene blue (MB) on the function of immunoglobulins of COVID-19 convalescent plasma (CCP). We have evaluated whether MB-treated CCP is ... ...

    Abstract Background and objectives: There is a concern about a possible deleterious effect of pathogen reduction (PR) with methylene blue (MB) on the function of immunoglobulins of COVID-19 convalescent plasma (CCP). We have evaluated whether MB-treated CCP is associated with a poorer clinical response compared to other inactivation systems at the ConPlas-19 clinical trial.
    Materials and methods: This was an ad hoc sub-study of the ConPlas-19 clinical trial comparing the proportion of patients transfused with MB-treated CCP who had a worsening of respiration versus those treated with amotosalen (AM) or riboflavin (RB).
    Results: One-hundred and seventy-five inpatients with SARS-CoV-2 pneumonia were transfused with a single CCP unit. The inactivation system of the CCP units transfused was MB in 90 patients (51.4%), RB in 60 (34.3%) and AM in 25 (14.3%). Five out of 90 patients (5.6%) transfused with MB-treated CCP had worsening respiration compared to 9 out of 85 patients (10.6%) treated with alternative PR methods (p = 0.220). Of note, MB showed a trend towards a lower rate of respiratory progressions at 28 days (risk ratio, 0.52; 95% confidence interval, 0.18-1.50).
    Conclusion: Our data suggest that MB-treated CCP does not provide a worse clinical outcome compared to the other PR methods for the treatment of COVID-19.
    MeSH term(s) Humans ; COVID-19/therapy ; COVID-19 Serotherapy ; Immunization, Passive/methods ; Methylene Blue/pharmacology ; Methylene Blue/therapeutic use ; SARS-CoV-2 ; Treatment Outcome
    Chemical Substances Methylene Blue (T42P99266K)
    Language English
    Publishing date 2023-02-03
    Publishing country England
    Document type Clinical Trial ; Journal Article
    ZDB-ID 80313-3
    ISSN 1423-0410 ; 0042-9007
    ISSN (online) 1423-0410
    ISSN 0042-9007
    DOI 10.1111/vox.13406
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia.

    Avendaño-Solá, Cristina / Ramos-Martínez, Antonio / Muñez-Rubio, Elena / Ruiz-Antorán, Belen / Malo de Molina, Rosa / Torres, Ferran / Fernández-Cruz, Ana / Calderón-Parra, Jorge / Payares-Herrera, Concepcion / Díaz de Santiago, Alberto / Romera-Martínez, Irene / Pintos, Ilduara / Lora-Tamayo, Jaime / Mancheño-Losa, Mikel / Paciello, Maria L / Martínez-González, A L / Vidán-Estévez, Julia / Nuñez-Orantos, Maria J / Saez-Serrano, Maria Isabel /
    Porras-Leal, Maria L / Jarilla-Fernández, Maria C / Villares, Paula / de Oteyza, Jaime Pérez / Ramos-Garrido, Ascension / Blanco, Lydia / Madrigal-Sánchez, Maria E / Rubio-Batllés, Martin / Velasco-Iglesias, Ana / Paño-Pardo, José R / Moreno-Chulilla, J A / Muñiz-Díaz, Eduardo / Casas-Flecha, Inmaculada / Pérez-Olmeda, Mayte / García-Pérez, Javier / Alcamí, Jose / Bueno, Jose L / Duarte, Rafael F

    The Journal of clinical investigation

    2021  Volume 131, Issue 20

    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. ...

    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.
    MeSH term(s) Aged ; COVID-19/mortality ; COVID-19/physiopathology ; COVID-19/therapy ; Combined Modality Therapy ; Disease Progression ; Female ; Hospitalization ; Humans ; Immunization, Passive/adverse effects ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Odds Ratio ; Pandemics ; SARS-CoV-2 ; Spain/epidemiology ; Treatment Outcome
    Language English
    Publishing date 2021-09-02
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 3067-3
    ISSN 1558-8238 ; 0021-9738
    ISSN (online) 1558-8238
    ISSN 0021-9738
    DOI 10.1172/JCI152740
    Database MEDical Literature Analysis and Retrieval System OnLINE

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