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1.
Artículo en Inglés | MEDLINE | ID: mdl-37032501

RESUMEN

INTRODUCTION: COVID convalescent plasma (CCP) has been used as standard of care in patients all over the world. CCP is plasma collected from recently infected and currently recovered COVID-19 patients, which contains antiviral antibodies that can be used to treat patients with COVID-19. Several studies have shown a shorter hospital stay and lower mortality in patients treated with convalescent plasma in comparison with those not treated with it. OBJECTIVES: This study aims to determine the effect of COVID convalescent plasma (CCP) on the length of hospital stay in symptomatic patients and to determine outcome of the disease in patients who were administered CCP. METHODS: This was a retrospective observational study done at a tertiary health care centre from July 2020 to May 2021, including patients who received CCP during the course of their stay in the hospital. RESULTS: Among 257 participants, the patients with multiple comorbidities who were administered CCP had the longest average length of stay in the hospital which was 15 days, out of which, 92 (35.8%) patients were discharged while 9 (3.5%) patients died. Also, the maximum number of deaths was observed in those patients who had no associated comorbidity, being 11 (4.3%). It was observed that earlier administration of CCP in patients (< 5 days from symptom onset) was associated with a higher number of discharges as compared to deaths. CONCLUSION: Our study indicates that CCP may be efficient in treating COVID-19 patients if given in early course of the disease.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , SARS-CoV-2 , Tiempo de Internación , Centros de Atención Terciaria , Inmunización Pasiva/efectos adversos , Sueroterapia para COVID-19
3.
Niger J Clin Pract ; 26(10): 1410-1422, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37929515

RESUMEN

Background: Convalescent plasma (CP) therapy can be defined as a passive immunity transfer approach involving the administration of plasma for therapeutic purposes to inpatients hospitalized due to an active virus infection. Passive immunity antibodies can reduce target organ damage and directly neutralize the responsible pathogens. A limited number of studies on the use of CP have reported that critically ill patients can benefit from CP therapy. Aim: We aimed in this study as the outcomes of CP therapy in critically ill coronavirus disease 2019 (COVID-19) patients in intensive care unit (ICU) and determine the differences between the recovery and mortality groups. Patients and Methods: This retrospective design study involved critically ill patients who were diagnosed with COVID-19 pneumonia or who were suspected of having COVID-19 in the ICU between April 1, 2020, and June 1, 2020. Comorbidity of patients, respiratory findings, hemodynamic data, laboratory data, and poor prognostic measures were compared between mortality and recovery group. Results: Convalescent plasma (CP) therapy was supplied for 41 (13.58%) patients in total of 302 COVID-19 patients. Twenty-nine patients were died in total of 41 COVID-19 patients who supplied CP therapy. The mortality rate is 70.73% in CP therapy. There was a significantly higher incidence (P < 0.021) of invasive mechanical ventilation (IMV) and significantly lower mean arterial pressure (MAP) values in mortality group (P < 0.05). There were significantly higher NLR values (P < 0.05), lower platelet count (P < 0.05), lower of glomerular filtration rate (GFR) level (P < 0.05), higher creatinine values (P < 0.05), higher lactate dehydrogenase (LDH) levels (P < 0.05), higher D-dimer levels (P < 0.05), higher level of pro-brain natriuretic peptide (BNP) (P = 0.000), rate of fever (P = 0.031), arrythmia (P = 0.024), and transfusion-associated circulatory overload (TACO) (P = 0.008) were more often in mortality group. Conclusion: Convalescent plasma therapy seems not useful in critically ill COVID-19 patients.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , Estudios Retrospectivos , SARS-CoV-2 , Enfermedad Crítica/terapia , Sueroterapia para COVID-19 , Inmunización Pasiva/efectos adversos
4.
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
5.
Transfusion ; 63(9): 1639-1648, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37534607

RESUMEN

BACKGROUND: COVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials. STUDY DESIGN AND METHODS: We analyzed data pertaining to transfusion-related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders. RESULTS: The combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic-type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients' underlying disease, COVID-19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43-1.31). Risk of urticaria and/or pruritus increased with a pre-existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16-4.67). We did not observe any CCP-attributed antibody disease enhancement in participants with COVID-19 or increased risk of infection. There were no life-threatening severe transfusion reactions and no patients required hospitalization related to transfusion-associated complications. DISCUSSION: Outpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID-19.


Asunto(s)
COVID-19 , Reacción a la Transfusión , Urticaria , Humanos , COVID-19/terapia , COVID-19/etiología , Sueroterapia para COVID-19 , Inmunización Pasiva/efectos adversos , Pacientes Ambulatorios , SARS-CoV-2 , Reacción a la Transfusión/etiología , Urticaria/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto
6.
Braz J Biol ; 83: e262897, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37493679

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.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , COVID-19/etiología , Inmunización Pasiva/efectos adversos , Resultado del Tratamiento , Sueroterapia para COVID-19 , SARS-CoV-2
7.
South Med J ; 116(5): 427-433, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-37137479

RESUMEN

OBJECTIVES: Current evidence favors plasma to be effective against coronavirus disease 2019 (COVID-19) in critically ill patients in the early stages of infection. We investigated the safety and efficacy of convalescent plasma in specifically late-stage (designated as after 2 weeks of hospital admission) severe COVID-19 infection. We also conducted a literature review on the late-stage use of plasma in COVID-19. METHODS: This case series examined eight COVID-19 patients admitted to the intensive care unit (ICU) who met criteria for severe or life-threatening complications. Each patient received one dose (200 mL) of plasma. Clinical information was gathered in intervals of 1 day pretransfusion and 1 hour, 3 days, and 7 days posttransfusion. The primary outcome was effectiveness of plasma transfusion, measured by clinical improvement, laboratory parameters, and all-cause mortality. RESULTS: Eight ICU patients received plasma late in the course of COVID-19 infection, on average at 16.13 days postadmission. On the day before transfusion, the averaged initial Sequential Organ Failure Assessment (SOFA) score, PaO2:FiO2 ratio, Glasgow Coma Scale (GCS), and lymphocyte count were 6.5, 228.03, 8.63, and 1.19, respectively. Three days after plasma treatment, the group averages for the SOFA score (4.86), PaO2:FiO2 ratio (302.73), GCS (9.29), and lymphocyte count (1.75) improved. Although the mean GCS improved to 10.14 by posttransfusion day 7, the other means marginally worsened with an SOFA score of 5.43, a PaO2:FiO2 ratio of 280.44, and a lymphocyte count of 1.71. Clinical improvement was noted in six patients who were discharged from the ICU. CONCLUSIONS: This case series provides evidence that convalescent plasma may be safe and effective in late-stage, severe COVID-19 infection. Results showed clinical improvement posttransfusion as well as decreased all-cause mortality in comparison to pretransfusion predicted mortality. Randomized controlled trials are needed to conclusively determine benefits, dosage, and timing of treatment.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , SARS-CoV-2 , Transfusión de Componentes Sanguíneos , Plasma , Sueroterapia para COVID-19 , Inmunización Pasiva/efectos adversos , Inmunización Pasiva/métodos
8.
J Infect Chemother ; 29(9): 869-874, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37178973

RESUMEN

BACKGROUND: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19). Despite its use for treating several viral infections, we lack comprehensive data on its efficacy against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: We conducted a multicenter, open-label, randomized controlled trial of convalescent plasma therapy with high neutralizing activity against SARS-CoV-2 in high-risk patients within five days after the onset of COVID-19 symptoms. The primary endpoint was the time-weighted average change in the SARS-CoV-2 viral load in nasopharyngeal swabs from days 0-5. RESULTS: Between February 24, 2021, and November 30, 2021, 25 patients were randomly assigned to either convalescent plasma (n = 14) or standard of care (n = 11) groups. Four patients discontinued their allocated convalescent plasma, and 21 were included in the modified intention-to-treat analysis. The median interval between the symptom onset and plasma administration was 4.5 days (interquartile range, 3-5 days). The primary outcome of the time-weighted average change in the SARS-CoV-2 viral load in nasopharyngeal swabs did not significantly differ between days 0-5 (1.2 log10 copies/mL in the convalescent plasma vs. 1.2 log10 copies/mL in the standard of care (effect estimate, 0.0 [95% confidence interval, -0.8-0.7]; P = 0.94)). No deaths were observed in either group. CONCLUSIONS: The early administration of convalescent plasma with high neutralizing activity did not contribute to a decrease in the viral load within five days compared with the standard of care alone.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , SARS-CoV-2 , Japón , Sueroterapia para COVID-19 , Inmunización Pasiva/efectos adversos , Resultado del Tratamiento
9.
Clin Infect Dis ; 77(7): 964-971, 2023 10 05.
Artículo en Inglés | MEDLINE | ID: mdl-37220751

RESUMEN

BACKGROUND: It is unknown whether convalescent immunoglobulins (cIgGs) are better than convalescent plasma (CP) for patients with coronavirus 2019 (COVID-19). METHODS: In this randomized controlled trial, we assigned high risk COVID-19 patients with ≤10 days of symptoms, to receive cIgGs or CP. The primary endpoint was improvement on day 14 according to the World Health Organization scale. Secondary endpoints were survival on day 14, and improvement, survival, and percent of ventilated patients on day 28, and treatment response in unvaccinated and vaccinated patients. RESULTS: A total of 319 patients were included: 166 received cIgGs and 153 CP. Median age was 64 to 66 years. A total of 112 patients (67.5%) in the cIgG group and 103 patients (67.3%) in the CP group reached the primary endpoint. Difference between groups was 0.1 (95% confidence interval, -10.1 to 10.4; P = .026), failing to reach noninferiority. More patients receiving cIgG improved by day 28 (136 patients [81.9%] and 108 patients [70.6%], respectively; 95% confidence interval, 1.9-20.7; P < .001; for superiority P = .018). Seventeen patients in the cIgG group (10.2%) and 25 patients (16.3%) in the CP group required mechanical ventilation (P = .136). Sixteen (9.6%) and 23 (15%) patients, respectively, died (P = .172). More unvaccinated patients improved by day 28 in the cIgG group (84.1% vs 66.1%; P = .024), and survival was better in the cIgG group (89.9% vs 77.4%; P = .066). CONCLUSIONS: cIgGs failed to reach the primary noninferiority endpoint on day 14 but was superior to CP on day 28. Survival and improvement by day 28 in unvaccinated patients treated with cIgGs were better. In the face of new variants, cIgGs are a viable option for treating COVID-19. TRIAL REGISTRATION NUMBER: My Trials MOH_2021-01-14_009667.


Asunto(s)
COVID-19 , Humanos , Persona de Mediana Edad , Anciano , COVID-19/terapia , SARS-CoV-2 , Inmunización Pasiva/efectos adversos , Resultado del Tratamiento , Sueroterapia para COVID-19 , Inmunoglobulinas
10.
Malays J Pathol ; 45(1): 87-95, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37119249

RESUMEN

INTRODUCTION: The objective of this study was to investigate the effect of convalescent plasma (CP) transfusion on clinical and serial laboratory parameters in severe COVID-19 patients. The Coronavirus Disease 2019 (COVID-19) pandemic presents a challenge to the healthcare system worldwide due to the limited treatment options available. The body of evidence reported that CP containing anti- COVID-19 antibodies could be effective against the infection. MATERIALS AND METHODS: This was a cross-sectional study that involved retrospective data collection of severe COVID-19 adult patients who received CP transfusion along with the best-of-care (CP group, n: 53) and best-of-care only (control group, n: 53). An age, gender, and comorbidity were manually matched approximately at a 1:1 ratio. RESULTS: The prevalence of adverse transfusion reactions was 5.7%. A shorter duration of oxygen support (median: 12 days vs 14 days, P=0.030) and a shorter duration of mechanical ventilation (median: 6 days vs 10 days, P=0.048) were found in the CP group. The laboratory parameters were also improved. However, there was no significant difference in the mechanical ventilation rate, length of hospital stay, length of intensive care unit (ICU) stay, and mortality rate across both groups (P = 0.492, 0.614, 0.793, 0.374). CONCLUSION: CP transfusion is safe and effective in the treatment of severe COVID-19 patients. However, a revision of our approaches such as early CP transfusion and use of a high-titre anti-COVID-19 neutralising antibody (nAb) unit is necessary to unlock the full potential benefits of CP transfusion among COVID-19 patients.


Asunto(s)
COVID-19 , Adulto , Humanos , COVID-19/terapia , SARS-CoV-2 , Transfusión de Componentes Sanguíneos , Estudios Transversales , Estudios Retrospectivos , Inmunización Pasiva/efectos adversos , Sueroterapia para COVID-19 , Plasma , Resultado del Tratamiento
11.
Expert Rev Hematol ; 16(4): 237-243, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-37009667

RESUMEN

INTRODUCTION: Secondary antibody deficiencies (SAD) are often a side effect of specific therapies that target B cells directly or affect the antibody response indirectly. Treatment of immunodeficiency by immunoglobulin replacement therapy (IgRT) is well established in primary antibody deficiencies, although the evidence for its use in SAD is less well established. To fill the gap and provide opinion and advice for daily practice, a group of experts met to discuss current issues and share best practical experience. AREAS COVERED: A total of 16 questions were considered that covered use of a tailored approach, definition of severe infections, measurement of IgG levels and specific antibodies, indications for IgRT, dosage, monitoring, discontinuation of IgRT, and Covid-19. EXPERT OPINION: Key points for better management SID should include characterization of the immunological deficiency, determination of the severity and degree of impairment of antibody production, distinguish between primary and secondary deficiency, and design a tailored treatment protocol that should include dose, route, and frequency of Ig replacement. There remains the need to carry out well-designed clinical studies to develop clear guidelines for the use of IgRT in patients with SAD.


Asunto(s)
COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Síndromes de Inmunodeficiencia , Humanos , Inmunoglobulinas/efectos adversos , Inmunización Pasiva/efectos adversos , Síndromes de Inmunodeficiencia/tratamiento farmacológico , Inmunoglobulinas Intravenosas/efectos adversos
12.
Transfusion ; 63(5): 918-924, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36965173

RESUMEN

BACKGROUND AND OBJECTIVES: Convalescent COVID-19 plasma (CCP) was developed and used worldwide as a treatment option by supplying passive immunity. Adult studies suggest administering high-titer CCP early in the disease course of patients who are expected to be antibody-negative; however, pediatric experience is limited. We created a multi-institutional registry to characterize pediatric patients (<18 years) who received CCP and to assess the safety of this intervention. METHODS: A REDCap survey was distributed. The registry collected de-identified data including demographic information (age, gender, and underlying conditions), COVID-19 disease features and concurrent treatments, CCP transfusion and safety events, and therapy response. RESULTS: Ninety-five children received CCP: 90 inpatients and 5 outpatients, with a median age of 10.2 years (range 0-17.9). They were predominantly Latino/Hispanic and White. The most frequent underlying medical conditions were chronic respiratory disease, immunosuppression, obesity, and genetic syndromes. CCP was primarily given as a treatment (95%) rather than prophylaxis (5%). Median total plasma dose administered and transfusion rates were 5.0 ml/kg and 2.6 ml/kg/h, respectively. The transfusions were well-tolerated, with 3 in 115 transfusions reporting mild reactions. No serious adverse events were reported. Severity scores decreased significantly 7 days after CCP transfusion or at discharge. Eighty-five patients (94.4%) survived to hospital discharge. All five outpatients survived to 60 days. CONCLUSIONS: CCP was found to be safe and well-tolerated in children. CCP was frequently given concurrently with other COVID-19-directed treatments with improvement in clinical severity scores ≥7 days after CCP, but efficacy could not be evaluated in this study.


Asunto(s)
COVID-19 , Adulto , Humanos , Niño , Recién Nacido , Lactante , Preescolar , Adolescente , COVID-19/terapia , COVID-19/etiología , SARS-CoV-2 , Inmunización Pasiva/efectos adversos , Sueroterapia para COVID-19 , Transfusión Sanguínea
13.
Viruses ; 15(3)2023 03 15.
Artículo en Inglés | MEDLINE | ID: mdl-36992465

RESUMEN

Patients receiving treatment with B-cell-depleting monoclonal antibodies, such as anti-CD20 monoclonal antibodies, such as rituximab and obinutuzumab, either for hematological disease or another diagnosis, such as a rheumatological disease, are at an increased risk for medical complications and mortality from COVID-19. Since inconsistencies persist regarding the use of convalescent plasma (CP), especially in the vulnerable patient population that has received previous treatment with B-cell-depleting monoclonal antibodies, further studies should be performed in thisdirection. The aim of the present study was to describe the characteristics of patients with previous use of B-cell-depleting monoclonal antibodies and describe the potential beneficial effects of CP use in terms of mortality, ICU admission and disease relapse. In this retrospective cohort study, 39 patients with previous use of B-cell-depleting monoclonal antibodies hospitalized in the COVID-19 department of a tertiary hospital in Greece were recorded and evaluated. The mean age was 66.3 years and 51.3% were male. Regarding treatment for COVID-19, remdesivir was used in 89.7%, corticosteroids in 94.9% and CP in 53.8%. In-hospital mortality was 15.4%. Patients who died were more likely to need ICU admission and also had a trend towards a longer hospital stay, even though the last did not reach statistical significance. Patients treated with CP had a lower re-admission rate for COVID-19 after discharge. Further studies should be performed to identify the role of CP in patients with treatment with B-cell-depleting monoclonal antibodies suffering from COVID-19.


Asunto(s)
COVID-19 , Humanos , Masculino , Anciano , Femenino , COVID-19/terapia , COVID-19/etiología , SARS-CoV-2 , Estudios Retrospectivos , Inmunización Pasiva/efectos adversos , Sueroterapia para COVID-19 , Anticuerpos Monoclonales/uso terapéutico
14.
Transfus Apher Sci ; 62(3): 103687, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36964059

RESUMEN

PURPOSE: Since 2020, the novel coronavirus infection (COVID-19) has spread globally. A few studies have investigated the safety of COVID-19 convalescent plasma (CCP) apheresis from COVID-19. This study was the first retrospective observational study of CCP in Japan. METHODS: We recruit donors from April 2020 to November 2021 and plasmapheresis in our center (NCGM: national center for global health and medicine). We set the primary endpoint as the Donors Adverse Event (DAE) occurrence at the time of the CCP collection. Variable selection was used to explore the determinants of DAE. RESULTS: Mean and SD age was 50.5 (10.6) years old. Seventy-three (42.2 %) were female, and 87 (33.3 %) were multiple-times donors. Twelve (6.97 % by donors and 4.6 % in total collections) adverse events occurred. The DAEs were VVR (Vaso Vagal Reaction), paresthesia, hypotension, agitation, dizziness, malaise, and hearing impairment/paresthesia. Half of them were VVR during apheresis. DAE occurred only in first-time donors and more in severe illnesses such as using ventilation and ECMO. From the donor characteristics and variable selection, the risk factors are as follows: younger age, female, the severity of disease at the time of the disease, and lower SBP before initiation. Our DAE incidence did not differ from previous studies. DAEs were more likely to occur in CCP apheresis than in healthy donors. CONCLUSION: We confirm the safety of CCP apheresis in this study, although DAEs were more than healthy donors. More caution should be exercised in the plasma collection for future outbreaks of emerging infectious diseases.


Asunto(s)
Eliminación de Componentes Sanguíneos , COVID-19 , Humanos , Femenino , Persona de Mediana Edad , Masculino , COVID-19/epidemiología , COVID-19/terapia , COVID-19/etiología , Japón/epidemiología , Parestesia/etiología , Sueroterapia para COVID-19 , Eliminación de Componentes Sanguíneos/efectos adversos , Donantes de Sangre , Inmunización Pasiva/efectos adversos
15.
J Infect Dis ; 227(11): 1266-1273, 2023 05 29.
Artículo en Inglés | MEDLINE | ID: mdl-36722044

RESUMEN

BACKGROUND: Coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) reduces hospitalizations among outpatients treated early after symptom onset. It is unknown whether CCP reduces time to symptom resolution among outpatients. METHODS: We evaluated symptom resolution at day 14 by trial arm using an adjusted subdistribution hazard model, with hospitalization as a competing risk. We also assessed the prevalence of symptom clusters at day 14 between treatments. Clusters were defined based on biologic clustering, impact on ability to work, and an algorithm. RESULTS: Among 1070 outpatients followed up after transfusion, 381 of 538 (70.8%) receiving CCP and 381 of 532 (71.6%) receiving control plasma were still symptomatic (P = .78) at day 14. Associations between CCP and symptom resolution by day 14 did not differ significantly from those in controls after adjustment for baseline characteristics (adjusted subdistribution hazard ratio, 0.99; P = .62). The most common cluster consisted of cough, fatigue, shortness of breath, and headache and was found in 308 (57.2%) and 325 (61.1%) of CCP and control plasma recipients, respectively (P = .16). CONCLUSIONS: In this trial of outpatients with early COVID-19, CCP was not associated with faster resolution of symptoms compared with control. Overall, there were no differences by treatment in the prevalence of each symptom or symptom clusters at day 14. CLINICAL TRIALS REGISTRATION: NCT04373460.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , SARS-CoV-2 , Pacientes Ambulatorios , Síndrome , Inmunización Pasiva/efectos adversos , Sueroterapia para COVID-19
16.
J Infect Dis ; 227(2): 206-210, 2023 01 11.
Artículo en Inglés | MEDLINE | ID: mdl-35921542

RESUMEN

BACKGROUND: The aim of this randomized, controlled trial is to determine whether antisevere acute respiratory syndrome coronavirus 2 hyperimmune globulin (COVIG) protects against severe coronavirus disease 2019 (COVID-19) in severely immunocompromised, hospitalized, COVID-19 patients. METHODS: Patients were randomly assigned to receive COVIG or intravenous immunoglobulin (IVIG) without SARS-CoV-2 antibodies. RESULTS: Severe COVID-19 was observed in 2 of 10 (20%) patients treated with COVIG compared to 7 of 8 (88%) in the IVIG control group (P = .015, Fisher's exact test). CONCLUSIONS: Antisevere acute respiratory syndrome coronavirus 2 hyperimmune globulin may be a valuable treatment in severely immunocompromised, hospitalized, COVID-19 patients and should be considered when no monoclonal antibody therapies are available.


Asunto(s)
COVID-19 , Humanos , SARS-CoV-2 , Inmunoglobulinas Intravenosas/uso terapéutico , Resultado del Tratamiento , Sueroterapia para COVID-19 , Inmunización Pasiva/efectos adversos
18.
Nat Cancer ; 4(1): 96-107, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36581734

RESUMEN

Patients with cancer are at high risk of severe coronavirus disease 2019 (COVID-19), with high morbidity and mortality. Furthermore, impaired humoral response renders severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines less effective and treatment options are scarce. Randomized trials using convalescent plasma are missing for high-risk patients. Here, we performed a randomized, open-label, multicenter trial ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE ) in hospitalized patients with severe COVID-19 (n = 134) within four risk groups ((1) cancer (n = 56); (2) immunosuppression (n = 16); (3) laboratory-based risk factors (n = 36); and (4) advanced age (n = 26)) randomized to standard of care (control arm) or standard of care plus convalescent/vaccinated anti-SARS-CoV-2 plasma (plasma arm). No serious adverse events were observed related to the plasma treatment. Clinical improvement as the primary outcome was assessed using a seven-point ordinal scale. Secondary outcomes were time to discharge and overall survival. For the four groups combined, those receiving plasma did not improve clinically compared with those in the control arm (hazard ratio (HR) = 1.29; P = 0.205). However, patients with cancer experienced a shortened median time to improvement (HR = 2.50; P = 0.003) and superior survival with plasma treatment versus the control arm (HR = 0.28; P = 0.042). Neutralizing antibody activity increased in the plasma cohort but not in the control cohort of patients with cancer (P = 0.001). Taken together, convalescent/vaccinated plasma may improve COVID-19 outcomes in patients with cancer who are unable to intrinsically generate an adequate immune response.


Asunto(s)
COVID-19 , Neoplasias , Humanos , COVID-19/terapia , SARS-CoV-2 , Inmunización Pasiva/efectos adversos , Resultado del Tratamiento , Sueroterapia para COVID-19 , Anticuerpos Antivirales , Neoplasias/terapia
19.
Enferm Infecc Microbiol Clin (Engl Ed) ; 40(9): 507-516, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-36336380

RESUMEN

Patients lacking humoral response have been suggested to develop a less severe COVID-19, but there are some reports with a prolonged, relapsing or deadly course. From April 2020, there is growing evidence on the benefits of COVID-19 convalescent plasma (CCP) for patients with humoral immunodeficiency. Most of them had a congenital primary immunodeficiency or were on treatment with anti CD20 antibodies. We report on three patients treated in our hospital and review thirty-one more cases described in the literature. All patients but three resolved clinical picture with CCP. A dose from 200 to 800ml was enough in most cases. Antibody levels after transfusion were negative or low, suggesting consumption of them in SARS-CoV-2 neutralization. These patients have a protracted clinical course shortened after CCP. CCP could be helpful for patients with humoral immunodeficiency. It avoid relapses and chronification. CCP should be transfused as early as possible in patients with COVID-19 and humoral immunodeficiency.


Asunto(s)
COVID-19 , Humanos , COVID-19/terapia , SARS-CoV-2 , Inmunización Pasiva/efectos adversos , Sueroterapia para COVID-19
20.
Pediatr Int ; 64(1): e15407, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-36326636

RESUMEN

BACKGROUND: Published data on coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) use in children and obstetric patients are limited. We describe a single-center experience of hospitalized patients who received CCP for acute COVID-19. METHODS: A retrospective review of children 0-18-years-old and pregnant patients hospitalized with laboratory-confirmed acute COVID-19 who received CCP from March 1, 2020 to March 1, 2021 was performed. Clinical and laboratory data were collected to assess the safety of CCP administration. Antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were measured in the CCP products and in patients before transfusion and at various time points post-transfusion. Correlation between the administered SARS-CoV-2 administered versus the SARS-CoV-2 anti-spike immunoglobulin response in patient serum was assessed. RESULTS: Twenty-two children and ten obstetric patients were eligible. Twelve pediatric and eight obstetric patients had moderate disease and ten pediatric and two obstetric patients had severe disease. Five pediatric patients died. Eighteen of 37 (48.6%) CCP titers that were measured met US Food and Drug Administration (FDA) criteria for high immunoglobulin G (IgG) antibody titer. There were no complications with transfusion. High-titer CCP showed a positive correlation with rise in patient total immunoglobulin levels only in obstetric patients but not in pediatric patients. Among pediatric patients, the median serum antibody level increased over time after transfusion. CONCLUSIONS: Coronavirus 2019 convalescent plasma was administered safely to our patients. Our study suggested that CCP did not interfere with endogenous antibody production. The antibody titer of CCP correlated with post-transfusion response only in obstetric patients. Randomized trials in pediatric and obstetric patients are needed to further understand how to dose CCP and evaluate efficacy.


Asunto(s)
COVID-19 , Humanos , Niño , Recién Nacido , Lactante , Preescolar , Adolescente , COVID-19/terapia , COVID-19/etiología , SARS-CoV-2 , Inmunización Pasiva/efectos adversos , Sueroterapia para COVID-19 , Inmunoglobulina G , Anticuerpos Antivirales
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