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1.
Artículo en Inglés | MEDLINE | ID: mdl-39126485

RESUMEN

Convalescent plasma has increasingly been used to treat various viral infections and confer post-exposure prophylactic protection during the last decade and has demonstrated favorable clinical outcomes in patients infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) during the recent COVID-19 pandemic. The pandemic has highlighted the need for cost-effective, accessible, and easy-to-use alternatives to conventional blood plasmapheresis techniques, allowing hospitals to become more self-sufficient in harvesting and transfusing donor plasma into recipients in a single setting. To this end, the use of a membrane-based bedside plasmapheresis device (HemoClear) was evaluated in an open-label, non-randomized prospective trial in Suriname in 2021, demonstrating its practicality and efficacy in a low-to middle-income country. This paper will review the use of this method and its potential to expedite the process of obtaining convalescent plasma, especially during pandemics and in resource-constrained settings.

2.
Braz. j. med. biol. res ; 57: e13627, fev.2024. tab, graf
Artículo en Inglés | LILACS-Express | LILACS | ID: biblio-1574234

RESUMEN

The COVID-19 pandemic has driven the search for alternative therapies, including convalescent plasma, historically used in infectious diseases. Despite results in other diseases, its effectiveness against COVID-19 remains uncertain with conflicting results in clinical trials. A pragmatic, single-center, prospective, and open randomized controlled trial was carried out in a hospital in Brazil, with the aim of evaluating the impact of convalescent plasma on the clinical improvement of patients hospitalized with COVID-19. The World Health Organization (WHO) ordinal scale was used to measure clinical improvement, focusing on the reduction in disease severity by up to 2 points, while antibody and C-reactive protein levels were monitored over time. After hospital admission, participants were randomized 1:1 to receive convalescent plasma and standard treatment or to be part of the control group with standard treatment. Follow-up was carried out on days 1, 3, 7, 14 and/or at discharge. From January 14 to April 4, 2022, 38 patients were included, but 3 were excluded due to protocol deviations, resulting in a total of 35 patients: 19 in the control group and 16 in the plasma group. There was no significant difference in clinical improvement between the convalescent plasma group and the control group, nor in secondary outcomes. The study had limitations due to the small number of patients and limited representation of COVID-19 cases. Broader investigations are needed to integrate therapies into medical protocols, both for COVID-19 and other diseases. Conducting randomized studies is challenging due to the complexity of medical conditions and the variety of treatments available.

3.
mBio ; : e0177723, 2023 Nov 08.
Artículo en Inglés | MEDLINE | ID: mdl-37938024

RESUMEN

The use of convalescent plasma (CP) for hospitalized patients with SARS-CoV-2 infection might be a useful option in certain settings. Soon after the outbreak of COVID-19, the National Ministry of Health of Argentina recommended the use of CP transfusion for hospitalized patients with COVID-19 disease. Between 1 June and 3 October 2020, 480 patients, excluding those on invasive mechanical ventilation (IMV), received at least one CP infusion in the province of Santa Fe. We aimed to find factors associated with mortality among this cohort of patients. The median age was 60 years (interquartile range: 49-69 years) and 320 (66.7%) were males. Most of these patients (93.75%) received a single CP infusion, 82.1% and 95.6% before day 4 and day 7 of hospitalization, respectively. Anti-SARS-CoV-2 titers were determined in the CP units administered using Elecsys Anti-SARS-CoV-2 S assay. At 28 days of follow-up, 250 patients were discharged (52.1%), 131 (27.3%) remained hospitalized without and 16 (3.3%) with oxygen requirement, 27 (5.6%) were on IMV, and 56 (11.7%) had died. In the multivariate logistic regression analysis, the factors significantly associated with 28-day mortality were (i) requirement of IMV, (ii) the administration of CP after the third day of hospitalization, (iii) age, and (iv) number of comorbidities. The qualitative and quantitative analyses of antibodies against SARS-CoV-2 in the infused CP were not associated with mortality. Our findings may imply a seemingly favorable effect of CP administration among patients with severe COVID-19 disease when infused sooner after hospitalization.IMPORTANCEThe use of convalescent plasma (CP) could be an option for patients with severe COVID-19, especially in poor-resource countries where direct antiviral drugs are not commercially available. Currently, the U.S. Food and Drug Administration limits the CP administration for outpatients and inpatients with COVID-19 who are immunocompromised and only if high levels of anti-SARS-CoV-2 antibodies are confirmed in the CP unit. Although most of the randomized clinical trials failed to show a clear-cut benefit of CP in hospitalized patients with severe COVID-19, other studies have shown that if given early in the course of the disease, it might be a useful therapeutic option. In this retrospective study, we demonstrated that early treatment (within 3 days of hospitalization) was significantly associated with reduced 28-day mortality compared with those patients treated beyond day 3. The results from our study add up to the scientific evidence on the use of CP as a relatively safe, cheap, and possibly effective therapy in certain patients suffering from severe SARS-CoV-2 infection.

4.
Front Nephrol ; 3: 1132763, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37675346

RESUMEN

Coronavirus disease 2019 (COVID-19), an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, can have a wide range of clinical manifestations, ranging from asymptomatic disease to potentially life-threatening complications. Convalescent plasma therapy has been proposed as an effective alternative for the treatment of severe cases. The aim of this study was to follow a two-time renal transplant patient with severe COVID-19 treated with convalescent plasma over time from an immunologic and virologic perspective. A 42-year-old female patient, who was a two-time kidney transplant recipient, was hospitalized with COVID-19. Due to worsening respiratory symptoms, she was admitted to the intensive care unit, where she received two doses of convalescent plasma. We analyzed the dynamics of viral load in nasopharyngeal swab, saliva, and tracheal aspirate samples, before and after convalescent plasma transfusion. The levels of pro-inflammatory cytokines and antibody titers were also measured in serum samples. A significant decrease in viral load was observed after treatment in the saliva and nasopharyngeal swab samples, and a slight decrease was observed in tracheal aspirate samples. In addition, we found evidence of an increase in antibody titers after transfusion, accompanied by a decrease in the levels of several cytokines responsible for cytokine storm.

5.
Transfus Apher Sci ; 62(6): 103785, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37620184

RESUMEN

BACKGROUND: Convalescent plasma (CP) became a prominent treatment in the early stages of the SARS-CoV-2 pandemic. In Argentina, a randomized clinical trial was executed to compare the use of CP in inpatients with severe COVID-19 pneumonia versus placebo. No differences in clinical outcomes or overall mortality between groups were observed. We conducted a cohort study in outpatients enrolled in the trial to describe long-term antibody titer variations between CP and placebo recipients. METHODS: Patients' total SARS-CoV-2 IgG antibodies against spike protein were collected 3, 6 and 12 months after hospital discharge from August 2020 to December 2021. In addition, reinfections, deaths and vaccination status were retrieved. Statistical analysis was performed using antibody geometric mean titers (GMT). All estimations were made considering the date of the trial infusion (placebo or CP) as time 0. RESULTS: From the 93 patients included in the follow-up, 64 had received CP and 29 placebo. We excluded all 12-month measurements because they were collected after the patients' vaccination date. At 90 days post-infusion, patients had an antibody GMT of 8.1 (IQR 7.4-8.1) in the CP group and 8.8 (IQR 8.1-9.1) in the placebo group. At 180 days, both groups had a GMT of 8.1 (IQR 7.4-8.1). No statistical differences in GMT were found between CP and placebo groups at 90 days (p = 0.12) and 180 days (p = 0.25). No patients registered a new COVID-19 infection; one died in the CP group from an ischemic stroke. CONCLUSIONS: No differences were observed in long-term antibody titers in unvaccinated patients that received CP or placebo after severe COVID-19 pneumonia.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , COVID-19/etiología , SARS-CoV-2 , Estudios de Cohortes , Inmunización Pasiva/efectos adversos , Sueroterapia para COVID-19 , Anticuerpos Antivirales
6.
Clin Infect Dis ; 77(4): 565-573, 2023 08 22.
Artículo en Inglés | MEDLINE | ID: mdl-37099356

RESUMEN

BACKGROUND: Late-relapsing hepatitis after yellow fever (LHep-YF) during the convalescent phase of the disease has been described during recent yellow fever (YF) outbreaks in Brazil. LHep-YF is marked by a rebound in liver enzymes and nonspecific clinical manifestations around 46-60 days after YF symptom onset. METHODS: Here we have characterized the clinical course and risk factors for LHep-YF using data from a representative cohort of patients who survived YF in Brazil, 2017-2018. A total of 221 YF-positive patients were discharged from the infectious disease reference hospital in Minas Gerais and were followed up at 30, 45, and 60 days post-symptom onset. RESULTS: From 46 to 60 days post-symptom onset, 16% of YF patients (n = 36/221) exhibited a rebound of aminotransferases (aspartate aminotransferase or alanine aminotransferase >500 IU/L), alkaline phosphatase, and total bilirubin levels. Other etiologies of liver inflammation such as infectious hepatitis, autoimmune hepatitis, and metabolic liver disease were ruled out. Jaundice, fatigue, headache, and low platelet levels were associated with LHep-YF. Demographic factors, clinical manifestations, laboratory tests, ultrasound findings, and viral load during the acute phase of YF were not associated with the occurrence of LHep-YF. CONCLUSIONS: These findings provide new data on the clinical course of Late-relapsing hepatitis during the convalescent phase of YF and highlight the need for extended patient follow-up after acute YF.


Asunto(s)
Hepatitis A , Hepatitis , Vacuna contra la Fiebre Amarilla , Fiebre Amarilla , Humanos , Fiebre Amarilla/complicaciones , Fiebre Amarilla/epidemiología , Brotes de Enfermedades , Factores de Riesgo , Hepatitis/epidemiología , Hepatitis A/epidemiología , Brasil/epidemiología , Progresión de la Enfermedad
7.
mBio ; 14(2): e0337922, 2023 04 25.
Artículo en Inglés | MEDLINE | ID: mdl-36815780

RESUMEN

Convalescent plasma is a promising therapy for coronavirus disease 2019 (COVID-19), but its efficacy in intensive care unit (ICU) patients in low- and middle-income country settings such as Suriname is unknown. Bedside plasma separation using the HemoClear device made convalescent plasma therapy accessible as a treatment option in Suriname. Two hundred patients with severe SARS-CoV-2 infection requiring intensive care were recruited. Fifty eight patients (29%) received COVID-19 convalescent plasma (CCP) treatment in addition to standard of care (SOC). The CCP treatment and SOC groups were matched by age, sex, and disease severity scores. Mortality in the CCP treatment group was significantly lower than that in the SOC group (21% versus 39%; Fisher's exact test P = 0.0133). Multivariate analysis using ICU days showed that CCP treatment reduced mortality (hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.18 to 0.66; P = 0.001), while complication of acute renal failure (creatinine levels, >110 mol/L; HR, 4.45; 95% CI, 2.54 to 7.80; P < 0.0001) was independently associated with death. Decrease in chest X-ray score in the CCP treatment group (median -3 points, interquartile range [IQR] -4 to -1) was significantly greater than that in the SOC group (median -1 point, IQR -3 to 1, Mann-Whitney test P = 0.0004). Improvement in the PaO2/FiO2 ratio was also significantly greater in the CCP treatment group (median 83, IQR 8 to 140) than in the SOC group (median 35, IQR -3 to 92, Mann-Whitney P = 0.0234). Further research is needed for HemoClear-produced CCP as a therapy for SARS-CoV-2 infection together with adequately powered, randomized controlled trials. IMPORTANCE This study compares mortality and other endpoints between intensive care unit COVID-19 patients treated with convalescent plasma plus standard of care (CCP), and a control group of patients hospitalized in the same medical ICU facility treated with standard of care alone (SOC) in a low- and middle-income country (LMIC) setting using bedside donor whole blood separation by gravity (HemoClear) to produce the CCP. It demonstrates a significant 65% survival improvement in HemoClear-produced CCP recipients (HR, 0.35; 95% CI, 0.19 to 0.66; P = 0.001). Although this is an exploratory study, it clearly shows the benefit of using the HemoClear-produced CCP in ICU patients in the Suriname LMIC setting. Additional studies could further substantiate our findings and their applicability for both LMICs and high-income countries and the use of CCP as a prepared readiness method to combat new viral pandemics.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , COVID-19/etiología , SARS-CoV-2 , Suriname/epidemiología , Sueroterapia para COVID-19 , Cuidados Críticos , Unidades de Cuidados Intensivos , Inmunización Pasiva/métodos , Resultado del Tratamiento
8.
Braz. j. biol ; 83: e262897, 2023. tab, graf, ilus
Artículo en Inglés | VETINDEX | ID: biblio-1447656

RESUMEN

There have been several efforts to minimize the effects caused by the COVID-19 virus around the world. Vaccines were developed in record time and alternative therapies were studied and applied in several countries, such as the use of plasma from recovered patients. Identifying, systematically evaluating and summarizing the best available scientific evidence on the efficacy and safety of using plasma from recovered COVID-19 patients remains the objective of this study. The studies carried out showed that the application of convalescent plasma contributes to the reduction of mortality, viral load and length of hospital stay. However, the effectiveness of the therapy still raises doubts due to the number of patients evaluated in clinical studies, in addition to its high cost and limitations in terms of availability and implementation, with the drug being authorized only for hospital use.


Houve vários esforços para minimizar os efeitos causados pelo vírus COVID-19 em todo o mundo. As vacinas foram desenvolvidas em tempo recorde e terapias alternativas foram estudadas e aplicadas em vários países, como o uso de plasma de pacientes recuperados. Identificar, avaliar sistematicamente e resumir as melhores evidências científicas disponíveis sobre a eficácia e segurança do uso de plasma de pacientes recuperados com COVID-19 continua sendo o objetivo deste estudo. Os estudos realizados mostraram que a aplicação de plasma convalescente contribui para a redução da mortalidade, carga viral e tempo de internação hospitalar. No entanto, a eficácia da terapia ainda gera dúvidas devido ao número de pacientes avaliados em estudos clínicos, além de seu alto custo e limitações em termos de disponibilidade e implementação, sendo o medicamento autorizado apenas para uso hospitalar.


Asunto(s)
Inmunización Pasiva , Epidemias , COVID-19/terapia
9.
Adv Biomark Sci Technol ; 4: 36-53, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36404876

RESUMEN

Different biomarkers for SARS-CoV-2 have been linked to detection, diagnosis, treatment, disease progression, and development of new drugs and vaccines. The objective of this research was to evaluate various hematological, biochemicals, immunological, radiological and spirometric parameters in 20 adult patients convalescing from COVID-19 and their possible relationship with the clinical course of the disease. The frequencies of categorical variables were compared using the chi-square and Fisher's exact test. The levels of statistical significance were denoted in each figure legend. Two-dimensional clustering analysis was performed using MeV software from TIGR. The tests with P value of ≤ 0.05 were considered statistically significant. Most of the patients studied presented alterations in dissimilar laboratory, radiological and spirometric parameters, which were related to the clinical evolution of the disease. The results obtained show that certain hematological, biochemical, immunological and radiological parameters can be considered as biomarkers of sequela in adult COVID-19 patients, which allows their stratification, according to the degree of involvement or sequela, into three groups: I (mild degree of involvement or sequela), without lung lesions on computerized axial tomography (CT scan) and high values of IgG, C3 and hemoglobin, II (moderate degree of involvement or sequel), without lung lesions on CT scan, characterized by high levels of CD3+/CD4+ T lymphocytes and the rest of the variables with low values and III (severe degree of involvement or sequela), with lung lesions on CT scan and high values of erythrocyte sedimentation rate, monocytes and neutrophils, associated with lymphopenia and decreased concentrations of IgG and C3.

10.
Life (Basel) ; 12(11)2022 Nov 02.
Artículo en Inglés | MEDLINE | ID: mdl-36362922

RESUMEN

Background: The use of convalescent plasma (CP) has been considered for its immunological mechanisms that could benefit patients in moderate and severe stages of COVID-19. This study evaluated the safety and efficacy of the use of donor CP for COVID-19. Material and methods: A double-blind, randomized controlled clinical trial was conducted from May to October 2020. Thirty-nine participants with moderate (II) and severe (III) stages of COVID-19 confirmed by RT-PCR were included. The study randomization rate was set at 3:1. CPs were chosen for application with a neutralizing antibody titer of ≥1:32. Results: We observed a significantly lower 21-day post-transfusion mortality HR: 0.17 (95.0% CI [0.07−0.45, p < 0.001]) in the group receiving CP compared with the control group; protective units (PU) in the group receiving convalescent plasma after seven days were significantly higher (512 (32−16,384) vs. 96 (32−256), p = 0.01); the PAO2/FIO2 index showed a significant improvement in the group receiving CP (251.01 (109.4) vs. 109.2 (62.4), p < 0.001, in the control group). Conclusion: CP is safe and effective, as it decreased mortality in the CP group compared with the control group.

11.
Artículo en Español | LILACS-Express | LILACS | ID: biblio-1440950

RESUMEN

Objetivos: Explorar, desde las narrativas de la población de donantes de plasma convaleciente en un ensayo clínico, las experiencias en el proceso de donación de sangre. Métodos: Se realizó un estudio cualitativo con diseño fenomenológico. La investigación se llevó a cabo en un hospital de la seguridad social del Perú aplicándose entrevistas semiestructuradas a profundidad. Resultados: Se entrevistó a once donantes de plasma convaleciente. Se identificó que las principales motivaciones de los donantes fueron tanto el poder contribuir a la investigación nacional como, apoyar a pacientes afectados por la COVID-19. Los principales miedos se centran en el posible riesgo de contagio dentro del hospital. Por otro lado, los donantes resaltaron la atención y acompañamiento del personal de salud en el proceso. Las principales expectativas y sugerencias apuntan hacia una mayor difusión de las campañas de donación de sangre en general, con especial énfasis en el tema de seguridad, la mejora en el tiempo del procedimiento de donación (en el caso de la donación de plasma convaleciente, desde el enrolamiento hasta la extracción de plasma convaleciente) y, la implementación de espacios amigables para incentivar las futuras campañas de donación de sangre en general. Conclusiones: Las experiencias de los donantes de plasma convaleciente fueron positivas. Sin embargo, aún hay mejoras que realizar a nivel de procesos e infraestructuras para asegurar campañas exitosas de donación de sangre futuras.


Objectives: To know and explore from convalescent plasma donators' voices the experience in the blood donation process at a social security hospital. Methods: Qualitative study with a phenomenological design. The investigation was carried out in 01 hospitals of the social security of Peru. Semi-structured interviews were carried out. Results: Eleven donors of convalescent plasma were interviewed. The main motivations for donating were being able to contribute to national research and supporting patients affected by COVID-19. Fears focus on the possible risk of contagion within the hospital. Donors emphasised the attention and support of health personnel alongside the donation procedure. The main expectations and suggestions point towards greater dissemination of donation campaigns with special emphasis on safety. Likewise, an improvement in the time of the donation procedure (from enrolment to the extraction of convalescent plasma), and the implementation of friendly spaces to encourage future blood donation campaigns were highlighted. Conclusions: The experience of the convalescent plasma donors was positive. However, improvements must be made in terms of processes and infrastructure to ensure future successful blood donation campaigns.

12.
BMC Infect Dis ; 22(1): 575, 2022 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-35761219

RESUMEN

BACKGROUND: Convalescent plasma (CP) has been widely used to treat COVID-19 and is under study. However, the variability in the current clinical trials has averted its wide use in the current pandemic. We aimed to evaluate the safety and efficacy of CP in severe coronavirus disease 2019 (COVID-19) in the early stages of the disease. METHODS: A randomized controlled clinical study was conducted on 101 patients admitted to the hospital with confirmed severe COVID-19. Most participants had less than 14 days from symptoms onset and less than seven days from hospitalization. Fifty patients were assigned to receive CP plus standard therapy (ST), and 51 were assigned to receive ST alone. Participants in the CP arm received two doses of 250 mL each, transfused 24 h apart. All transfused plasma was obtained from "super donors" that fulfilled the following criteria: titers of anti-SARS-CoV-2 S1 IgG ≥ 1:3200 and IgA ≥ 1:800 antibodies. The effect of transfused anti-IFN antibodies and the SARS-CoV-2 variants at the entry of the study on the overall CP efficacy was evaluated. The primary outcomes were the reduction in viral load and the increase in IgG and IgA antibodies at 28 days of follow-up. The per-protocol analysis included 91 patients. RESULTS: An early but transient increase in IgG anti-S1-SARS-CoV-2 antibody levels at day 4 post-transfusion was observed (Estimated difference [ED], - 1.36; 95% CI, - 2.33 to - 0.39; P = 0.04). However, CP was not associated with viral load reduction in any of the points evaluated. Analysis of secondary outcomes revealed that those patients in the CP arm disclosed a shorter time to discharge (ED adjusted for mortality, 3.1 days; 95% CI, 0.20 to 5.94; P = 0.0361) or a reduction of 2 points on the WHO scale when compared with the ST group (HR adjusted for mortality, 1.6; 95% CI, 1.03 to 2.5; P = 0.0376). There were no benefits from CP on the rates of intensive care unit admission (HR, 0.82; 95% CI, 0.35 to 1.9; P = 0.6399), mechanical ventilation (HR, 0.66; 95% CI, 0.25 to 1.7; P = 0.4039), or mortality (HR, 3.2; 95% CI, 0.64 to 16; P = 0.1584). Anti-IFN antibodies and SARS-CoV-2 variants did not influence these results. CONCLUSION: CP was not associated with viral load reduction, despite the early increase in IgG anti-SARS-CoV-2 antibodies. However, CP is safe and could be a therapeutic option to reduce the hospital length of stay. Trial registration NCT04332835.


Asunto(s)
COVID-19 , Infecciones por Coronavirus , Neumonía Viral , Anticuerpos Antivirales , Betacoronavirus , COVID-19/terapia , Humanos , Inmunización Pasiva , Inmunoglobulina A , Inmunoglobulina G/uso terapéutico , SARS-CoV-2 , Resultado del Tratamiento , Sueroterapia para COVID-19
13.
Hematol., Transfus. Cell Ther. (Impr.) ; 44(2): 206-212, Apr.-June 2022. tab, graf
Artículo en Inglés | LILACS | ID: biblio-1385048

RESUMEN

Abstract Introduction Convalescent Plasma therapy is one of the therapeutic strategies that has been used for patients with the Covid-19 disease. Implementing a program with national extension to supply hospitals with this blood component is a great challenge mainly in a middle-income economy. Objectives Our objective was to develop and implement a Covid-19 Convalescent Plasma Program which met established quality standards and was adapted to a reality of limited resources. Methods A multicentric convalescent plasma collection program was developed and implemented, based on four main sequential procedures: selective donor recruitment, pre-donation antibody screening (Anti-SARS-CoV-2- Chemiluminescence IgG Abbott), convalescent plasma collection by apheresis or whole-blood processing and distribution to the hospitals according to local demand. Results From the 572 candidates submitted to the pre-donation antibody screening, only 270 (47%) were considered eligible for plasma donation according to the established criteria. Higher levels of total antibody were associated with the donor age being above 45 years old (p= 0.002), hospital admission (p= 0.018), and a shorter interval between the diagnosis of the SARS-CoV-2 infection and plasma donation (p < 0.001). There was no association between the ABO and Rh blood groups and their antibody levels. Of the 468 donations made, 61% were from the collection of whole-blood and 39%, from apheresis. The Covid-19 Convalescent Plasma units obtained were distributed to 21 different cities throughout the country by air or ground transportation. Conclusion The implementation of a Covid-19 Convalescent Plasma program in a continental country with relatively scarce resources is feasible with alternative strategies to promote lower cost procedures, while complying with local regulations and meeting quality standards.


Asunto(s)
Humanos , Masculino , Femenino , Adolescente , Adulto , Persona de Mediana Edad , Adulto Joven , Eliminación de Componentes Sanguíneos , Inmunización Pasiva , COVID-19/terapia , Plasma , SARS-CoV-2
14.
Lancet Reg Health Am ; 10: 100216, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35308034

RESUMEN

Background: Administration of convalescent plasma may serve as an adjunct to supportive treatment to prevent COVID-19 progression and death. We aimed to evaluate the efficacy and safety of 2 volumes of intravenous convalescent plasma (CP) with high antibody titers for the treatment of severe cases of COVID-19. Methods: We conducted a Bayesian, randomized, open-label, multicenter, controlled clinical trial in 7 Brazilian hospitals. Adults admitted to hospital with positive RT-PCR for SARS-CoV2, within 10 days of the symptom onset, were eligible. Patients were randomly assigned (1:1:1) to receive standard of care (SoC) alone, or in combination with 200 mL (150-300 mL) of CP (Low-volume), or 400 mL (300-600 mL) of CP (High-volume); infusion had to be performed within 24 h of randomization. Randomization was centralized, stratified by center. The primary outcome was the time until clinical improvement up to day 28, measured by the WHO ten-point scale, assessed in the intention-to-treat population. Interim and terminal analyses were performed in a Bayesian framework. Trial registered at ClinicalTrials.gov: NCT04415086. Findings: Between June 2, 2020, and November 18, 2020, 129 patients were enrolled and randomly assigned to SoC (n = 42), Low-volume (n = 43) or High-volume (n = 44) CP. Donors presented a median titer of neutralizing antibodies of 1:320 (interquartile range, 1:160 to 1:1088). No evidence of any benefit of convalescent plasma was observed, with Bayesian estimate of 28-day clinical improvement of 72.7% (95%CI, 58.8 to 84.7) in the SoC versus 64.1% (95%ci, 53.8 to 73.7) in the pooled experimental groups (mean difference of -8.7%, 95%CI, -24.6 to 8.2). There was one case of cutaneous mild allergic reaction related to plasma transfusion and one case of suspected transfusion-related acute lung injury but deemed not to be related to convalescent plasma infusion. Interpretation: In this prospective, randomized trial of adult hospitalized patients with severe COVID-19, convalescent plasma was not associated with clinical benefits. Funding: Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.

15.
São Paulo med. j ; São Paulo med. j;140(1): 12-16, Jan.-Feb. 2022. tab
Artículo en Inglés | LILACS | ID: biblio-1357469

RESUMEN

ABSTRACT BACKGROUND: Coronavirus disease 2019 (COVID-19) is an ongoing global health threat. However, currently, no standard therapy has been approved for the disease. OBJECTIVES: To evaluate the clinical effectiveness of convalescent plasma (CP) in patients with acute respiratory distress syndrome (ARDS) due to COVID-19. DESIGN AND SETTING: Retrospective study conducted at Kayseri City Education and Research Hospital, Kayseri, Turkey. METHODS: The case group consisted of adult patients (> 18 years) with ARDS due to COVID-19 who received CP in combination with antiviral and supportive treatment. These patients were compared with others who only received antiviral and supportive treatment. RESULTS: During the study period, a total of 30 patients with ARDS due to COVID-19 were included. Eleven patients (36%) received CP in combination with antiviral and supportive treatment, whereas nineteen patients (64%) in the control group only received antiviral and supportive treatment. On admission, the median age, demographic and clinical data and initial laboratory test results were similar between the groups (P > 0.05). On the 14th day of treatment, the laboratory values remained similar between the groups (P > 0.05). The mortality rates were not significantly different between the groups. CONCLUSION: CP treatment did not affect mortality or lead to clinical improvement for COVID-19 patients with ARDS.


Asunto(s)
Humanos , Adulto , Síndrome de Dificultad Respiratoria del Recién Nacido/etiología , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , COVID-19/etiología , Estudios Retrospectivos , Inmunización Pasiva , SARS-CoV-2
16.
Hematol Transfus Cell Ther ; 44(2): 206-212, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35071990

RESUMEN

Introduction: Convalescent Plasma therapy is one of the therapeutic strategies that has been used for patients with the Covid-19 disease. Implementing a program with national extension to supply hospitals with this blood component is a great challenge mainly in a middle-income economy. Objectives: Our objective was to develop and implement a Covid-19 Convalescent Plasma Program which met established quality standards and was adapted to a reality of limited resources. Methods: A multicentric convalescent plasma collection program was developed and implemented, based on four main sequential procedures: selective donor recruitment, pre-donation antibody screening (Anti-SARS-CoV-2- Chemiluminescence IgG Abbott), convalescent plasma collection by apheresis or whole-blood processing and distribution to the hospitals according to local demand. Results: From the 572 candidates submitted to the pre-donation antibody screening, only 270 (47%) were considered eligible for plasma donation according to the established criteria. Higher levels of total antibody were associated with the donor age being above 45 years old (p = 0.002), hospital admission (p = 0.018), and a shorter interval between the diagnosis of the SARS-CoV-2 infection and plasma donation (p < 0.001). There was no association between the ABO and Rh blood groups and their antibody levels. Of the 468 donations made, 61% were from the collection of whole-blood and 39%, from apheresis. The Covid-19 Convalescent Plasma units obtained were distributed to 21 different cities throughout the country by air or ground transportation. Conclusion: The implementation of a Covid-19 Convalescent Plasma program in a continental country with relatively scarce resources is feasible with alternative strategies to promote lower cost procedures, while complying with local regulations and meeting quality standards.

17.
Transfus Med ; 32(2): 153-161, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35001439

RESUMEN

INTRODUCTION: South America is one of the regions most affected by the COVID-19 pandemic. Specific and affordable treatments are needed to treat SARS-CoV-2 infection. Evidence regarding the use of convalescent plasma in COVID-19 patients is still limited. We compared the safety and efficacy of COVID-19-convalescent plasma administration as a complement to standard treatment in the early management of patients with moderate SARS-CoV-2 infection. METHODS: We carried out a random double blinded, placebo-controlled trial that compared standard treatment plus convalescent plasma (CP) or plus non-convalescent plasma in the management of COVID-19 patients. The main outcome was survival and secondary endpoints included: length of hospitalisation (LOH), days from treatment to discharge, time to clinical improvement or death within a 28-day period, and adverse reactions to treatment. RESULTS: Administration of CP with antibodies against SARS-CoV-2 did not affect patient survival, RR = 1.003, 95% CI (0.3938, 2.555). These results led to terminate the RCT prematurely. However, early treatment of COVID-19 patients with CP tended to decrease the LOH while the delay in CP treatment was associated with longer hospitalisation. In addition, delay in CP treatment negatively affected the recovery of the respiratory rate. CONCLUSION: Use of CP for the treatment of COVID-19 patients is safe and its early use can decrease the LOH and improve respiratory function. Early administration of antibody-rich CP could contribute to decrease the negative impact of COVID-19 pandemic in patients with impaired immune response.


Asunto(s)
COVID-19 , Inmunización Pasiva , COVID-19/terapia , Humanos , Inmunización Pasiva/métodos , Pandemias , SARS-CoV-2 , Sueroterapia para COVID-19
18.
Hematol., Transfus. Cell Ther. (Impr.) ; 44(1): 1-6, Jan.-Mar. 2022. tab, graf
Artículo en Inglés | LILACS | ID: biblio-1364895

RESUMEN

Abstract Introduction As the Coronavirus Disease 2019 (COVID-19) pandemic unfolds around the world; answers related to the antibody response against the virus are necessary to develop treatment and prophylactic strategies. We attempted to understand part of the immune response of convalescent plasma donation candidates. Method We carried out a cross-sectional, observational, non-intervention study, testing 102 convalescent plasma donation candidates for antibodies against the virus, relating these data to the time interval between symptom onset and sample collection, age, disease severity, and gender. Results In our sample, the individuals who developed a greater antibody response were the ones who had a longer time interval between symptom onset and sample collection, the ones who had been hospitalized and the subjects above 35 years old. Moreover, 17 individuals did not present any reactive antibodies. Conclusion These results are important in that they raise questions about the role of the humoral response against the virus, as some individuals do not develop antibodies to fight it. In addition, they help develop recruitment strategies for convalescent plasma donors, who should be asymptomatic for at least 21 days and are possibly more likely to have reactive antibodies after 35 days without symptoms.


Asunto(s)
Humanos , Masculino , Femenino , Adolescente , Adulto , Persona de Mediana Edad , Adulto Joven , Infecciones por Coronavirus , Prueba Serológica para COVID-19 , COVID-19 , Plasma , Donantes de Sangre , SARS-CoV-2
19.
Hematol Transfus Cell Ther ; 44(1): 1-6, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-34751255

RESUMEN

INTRODUCTION: As the Coronavirus Disease 2019 (COVID-19) pandemic unfolds around the world; answers related to the antibody response against the virus are necessary to develop treatment and prophylactic strategies. We attempted to understand part of the immune response of convalescent plasma donation candidates. METHOD: We carried out a cross-sectional, observational, non-intervention study, testing 102 convalescent plasma donation candidates for antibodies against the virus, relating these data to the time interval between symptom onset and sample collection, age, disease severity, and gender. RESULTS: In our sample, the individuals who developed a greater antibody response were the ones who had a longer time interval between symptom onset and sample collection, the ones who had been hospitalized and the subjects above 35 years old. Moreover, 17 individuals did not present any reactive antibodies. CONCLUSION: These results are important in that they raise questions about the role of the humoral response against the virus, as some individuals do not develop antibodies to fight it. In addition, they help develop recruitment strategies for convalescent plasma donors, who should be asymptomatic for at least 21 days and are possibly more likely to have reactive antibodies after 35 days without symptoms.

20.
Einstein (São Paulo, Online) ; 20: eRC6550, 2022. graf
Artículo en Inglés | LILACS | ID: biblio-1360401

RESUMEN

ABSTRACT The coronavirus disease 19 (COVID-19) is responsible for the current worldwide pandemic. Treatment and prophylaxis are still under investigation. Convalescent plasma therapy could be an alternative. We report a case of a 41-year-old patient, at 28 weeks of gestation, was hospitalized with COVID-19. On the 10th day after onset of symptoms, the clinical picture worsened, and she required high-flow oxygen therapy (30L/minute), with 92% oxygen saturation, and chest X-ray showing mild bilateral opacities at lung bases. Blood tests showed D-dimer 1,004ng/mL, C-reactive protein 81mg/L, pro-calcitonin 0.05ng/mL and interleukine-6 42.9pg/mL. The therapy chosen was Tazocin® 12g/day, vancomycin 2g/day, and methylprednisolone 40mg/day. In addition, convalescent plasma therapy was administered (275mL) uneventfully, including SARS-CoV-2 antibodies and neutralizing antibodies >1:160. The patient had a fast recovery. The early administration of convalescent plasma, with high titers of neutralizing antibodies, may be an alternative option for severe COVID-19 during pregnancy, until further studies demonstrate an efficient and safe treatment or prophylaxis.


Asunto(s)
Humanos , Femenino , Embarazo , Adulto , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , COVID-19/terapia , Inmunización Pasiva , Mujeres Embarazadas , SARS-CoV-2
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