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2.
Am J Case Rep ; 21: e927812, 2020 Oct 03.
Artículo en Inglés | MEDLINE | ID: covidwho-854653

RESUMEN

BACKGROUND This is a case report of an immunocompromised patient with a history of non-Hodgkin lymphoma and persistent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection who was seronegative and successfully treated with convalescent plasma. CASE REPORT A 63-year-old woman with a past medical history of non-Hodgkin lymphoma in remission while on maintenance therapy with the anti-CD20 monoclonal antibody, obinutuzumab, tested positive for SARS-CoV-2 via nasopharyngeal reverse transcription polymerase chain reaction (RT-PCR) testing over 12 weeks and persistently tested seronegative for immunoglobulin G (IgG) antibodies using SARS-CoV-2 IgG chemiluminescent microparticle immunoassay technology. During this time, the patient experienced waxing and waning of symptoms, which included fever, myalgia, and non-productive cough, but never acquired severe respiratory distress. She was admitted to our hospital on illness day 88, and her symptoms resolved after the administration of convalescent plasma. CONCLUSIONS As the understanding of the pathogenesis of SARS-CoV-2 continues to evolve, we can currently only speculate about the occurrence of chronic infection vs. reinfection. The protective role of antibodies and their longevity against SARS-CoV-2 remain unclear. Since humoral immunity has an integral role in SARS-CoV-2 infection, various phase 3 vaccine trials are underway. In the context of this pandemic, the present case demonstrates the challenges in our understanding of testing and treating immunocompromised patients.


Asunto(s)
Anticuerpos Monoclonales Humanizados/administración & dosificación , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/diagnóstico , Huésped Inmunocomprometido , Linfoma no Hodgkin/inmunología , Neumonía Viral/complicaciones , Neumonía Viral/diagnóstico , Antineoplásicos Inmunológicos/administración & dosificación , Técnicas de Laboratorio Clínico/métodos , Infecciones por Coronavirus/terapia , Femenino , Estudios de Seguimiento , Humanos , Inmunización Pasiva/métodos , Linfoma no Hodgkin/complicaciones , Linfoma no Hodgkin/tratamiento farmacológico , Persona de Mediana Edad , Pandemias , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Pruebas Serológicas/métodos , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
3.
Dtsch Arztebl Int ; 117(29-30): 500-506, 2020 07 20.
Artículo en Inglés | MEDLINE | ID: covidwho-853888

RESUMEN

BACKGROUND: The histomorphological changes of lung damage in severe coronavirus disease 2019 (COVID-19) have not yet been adequately characterized. In this article, we describe the sequence of pathological changes in COVID-19 and discuss the implications for approaches to treatment. METHODS: Standardized autopsies were performed on thirteen patients who had died of COVID-19. The findings were analyzed together with clinical data from the patients' medical records. RESULTS: Most (77%) of the deceased patients were men. Their median age at death was 78 years (range, 41-90). Most of them had major pre-existing chronic diseases, most commonly arterial hypertension. The autopsies revealed characteristic COVID-19-induced pathological changes in the lungs, which were regarded as the cause of death in most patients. The main histological finding was sequential alveolar damage, apparently due in large measure to focal capillary microthrombus formation. Alveolar damage leads to the death of the patient either directly or by the induction of pulmonary parenchymal fibrosis. Diffuse lung damage was seen exclusively in invasively ventilated patients. CONCLUSION: Autopsies are crucial for the systematic assessment of new diseases such as COVID-19: they provide a basis for further investigations of disease mechanisms and for the devising of potentially effective modes of treatment. The autopsy findings suggest that focal damage of the microvascular pulmonary circulation is a main mechanism of lethal lung disease due to the SARS-CoV-2 virus. It may also be a cause of persistent lung damage in patients who recover from severe COVID-19.


Asunto(s)
Infecciones por Coronavirus/complicaciones , Lesión Pulmonar/patología , Lesión Pulmonar/virología , Neumonía Viral/complicaciones , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias , Índice de Severidad de la Enfermedad
5.
BMJ Open ; 10(10): e039887, 2020 10 05.
Artículo en Inglés | MEDLINE | ID: covidwho-835489

RESUMEN

OBJECTIVES: To determine the age-specific clinical presentations and incidence of adverse outcomes among patients with COVID-19 in Jiangsu, China. DESIGN AND SETTING: Retrospective, multicentre cohort study performed at 24 hospitals in Jiangsu, China. PARTICIPANTS: 625 patients with COVID-19 enrolled between 10 January and 15 March 2020. RESULTS: Of the 625 patients (median age, 46 years; 329 (52.6%) men), 37 (5.9%) were children (18 years or younger), 261 (41.8%) young adults (19-44 years), 248 (39.7%) middle-aged adults (45-64 years) and 79 (12.6%) elderly adults (65 years or older). The incidence of hypertension, coronary heart disease, chronic obstructive pulmonary disease and diabetes comorbidities increased with age (trend test, p<0.0001, p=0.0003, p<0.0001 and p<0.0001, respectively). Fever, cough and shortness of breath occurred more commonly among older patients, especially the elderly, compared with children (χ2 test, p=0.0008, 0.0146 and 0.0282, respectively). The quadrant score and pulmonary opacity score increased with age (trend test, both p<0.0001). Older patients had many significantly different laboratory parameters from younger patients. Elderly patients had the highest proportion of severe or critically-ill cases (33.0%, χ2 test p<0.0001), intensive care unit use (35.4%, χ2 test p<0.0001), respiratory failure (31.6%, χ2 test p<0.0001) and the longest hospital stay (median 21 days, Kruskal-Wallis test p<0.0001). CONCLUSIONS: Elderly (≥65 years) patients with COVID-19 had the highest risk of severe or critical illness, intensive care use, respiratory failure and the longest hospital stay, which may be due partly to their having a higher incidence of comorbidities and poor immune responses to COVID-19.


Asunto(s)
Factores de Edad , Infecciones por Coronavirus , Cuidados Críticos , Pulmón/diagnóstico por imagen , Pandemias , Neumonía Viral , Evaluación de Síntomas , Adolescente , Anciano , Betacoronavirus/aislamiento & purificación , China/epidemiología , Estudios de Cohortes , Comorbilidad , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/fisiopatología , Cuidados Críticos/métodos , Cuidados Críticos/estadística & datos numéricos , Enfermedad Crítica/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/fisiopatología , Estudios Retrospectivos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Evaluación de Síntomas/métodos , Evaluación de Síntomas/estadística & datos numéricos
6.
Signal Transduct Target Ther ; 5(1): 219, 2020 10 06.
Artículo en Inglés | MEDLINE | ID: covidwho-834861

RESUMEN

Convalescent plasma (CP) transfusion has been indicated as a promising therapy in the treatment for other emerging viral infections. However, the quality control of CP and individual variation in patients in different studies make it rather difficult to evaluate the efficacy and risk of CP therapy for coronavirus disease 2019 (COVID-19). We aimed to explore the potential efficacy of CP therapy, and to assess the possible factors associated with its efficacy. We enrolled eight critical or severe COVID-19 patients from four centers. Each patient was transfused with 200-400 mL of CP from seven recovered donors. The primary indicators for clinical efficacy assessment were the changes of clinical symptoms, laboratory parameters, and radiological image after CP transfusion. CP donors had a wide range of antibody levels measured by serology tests which were to some degree correlated with the neutralizing antibody (NAb) level. No adverse events were observed during and after CP transfusion. Following CP transfusion, six out of eight patients showed improved oxygen support status; chest CT indicated varying degrees of absorption of pulmonary lesions in six patients within 8 days; the viral load was decreased to a negative level in five patients who had the previous viremia; other laboratory parameters also tended to improve, including increased lymphocyte counts, decreased C-reactive protein, procalcitonin, and indicators for liver function. The clinical efficacy might be associated with CP transfusion time, transfused dose, and the NAb levels of CP. This study indicated that CP might be a potential therapy for severe patients with COVID-19.


Asunto(s)
Anticuerpos Neutralizantes/administración & dosificación , Anticuerpos Antivirales/administración & dosificación , Betacoronavirus/patogenicidad , Infecciones por Coronavirus/terapia , Neumonía Viral/terapia , Adulto , Anciano , Antivirales/uso terapéutico , Betacoronavirus/inmunología , Biomarcadores/sangre , Proteína C-Reactiva/metabolismo , Técnicas de Laboratorio Clínico , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/diagnóstico por imagen , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/patología , Progresión de la Enfermedad , Femenino , Humanos , Inmunización Pasiva/métodos , Pruebas de Función Hepática , Masculino , Persona de Mediana Edad , Pandemias , Neumonía Viral/diagnóstico por imagen , Neumonía Viral/inmunología , Neumonía Viral/patología , Polipéptido alfa Relacionado con Calcitonina/sangre , Índice de Severidad de la Enfermedad , Tomografía Computarizada por Rayos X , Carga Viral
9.
J Med Virol ; 92(7): 807-813, 2020 07.
Artículo en Inglés | MEDLINE | ID: covidwho-823738

RESUMEN

In December 2019, an outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infection occurred in Wuhan, and rapidly spread to worldwide, which has attracted many people's concerns about the patients. However, studies on the infection status of medical personnel is still lacking. A total of 54 cases of SARS-Cov-2 infected medical staff from Tongji Hospital between 7 January and 11 February 2020 were analyzed in this retrospective study. Clinical and epidemiological characteristics were compared between different groups by statistical method. From 7 January to 11 February 2020, 54 medical staff of Tongji Hospital were hospitalized due to coronavirus disease 2019 (COVID-19). Most of them were from other clinical departments (72.2%) rather than emergency department (3.7%) or medical technology departments (18.5%). Among the 54 patients with COVID-19, the distribution of age had a significant difference between non-severe type and severe/critical cases (median age: 47 years vs 38 years; P = .0015). However, there was no statistical difference in terms of gender distribution and the first symptoms between theses two groups. Furthermore, we observed that the lesion regions in SARS-Cov-2 infected lungs with severe-/critical-type of medical staff were more likely to exhibit lesions in the right upper lobe (31.7% vs 0%; P = .028) and right lung (61% vs 18.2%; P = .012). Based on our findings with medical staff infection data, we suggest training for all hospital staff to prevent infection and preparation of sufficient protection and disinfection materials.


Asunto(s)
Betacoronavirus/patogenicidad , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/transmisión , Transmisión de Enfermedad Infecciosa de Paciente a Profesional/clasificación , Neumonía Viral/fisiopatología , Neumonía Viral/transmisión , Adulto , Anciano , Antibacterianos/uso terapéutico , Antivirales/uso terapéutico , Betacoronavirus/efectos de los fármacos , China , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/tratamiento farmacológico , Femenino , Departamentos de Hospitales/clasificación , Humanos , Inmunoglobulinas/uso terapéutico , Interferones/uso terapéutico , Masculino , Cuerpo Médico de Hospitales , Persona de Mediana Edad , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/tratamiento farmacológico , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
10.
Trials ; 21(1): 828, 2020 Oct 06.
Artículo en Inglés | MEDLINE | ID: covidwho-818132

RESUMEN

OBJECTIVES: Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge. TRIAL DESIGN: Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care. PARTICIPANTS: High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1µg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs). INTERVENTION AND COMPARATOR: This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O2 saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition. MAIN OUTCOMES: Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment). RANDOMISATION: Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants). BLINDING (MASKING): The study is open-label, no blinding will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total number of 174 patients is required for the entire trial, n=87 per group. TRIAL STATUS: Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3rd Quarter 2020 Last patient first visit (LPFV): 2nd Quarter 2021 Last patient last visit (LPLV): 3rd Quarter 2021 Trial Report completed: 4th Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).


Asunto(s)
Anticuerpos Antivirales/sangre , Betacoronavirus , Infecciones por Coronavirus , Pandemias , Plasma/inmunología , Neumonía Viral , Anciano , Betacoronavirus/inmunología , Betacoronavirus/aislamiento & purificación , Ensayos Clínicos Fase II como Asunto , Convalecencia , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/terapia , Femenino , Humanos , Inmunización Pasiva/métodos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/métodos , Estudios Multicéntricos como Asunto , Neumonía Viral/diagnóstico , Neumonía Viral/inmunología , Neumonía Viral/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Ajuste de Riesgo , Índice de Severidad de la Enfermedad
11.
Radiology ; 297(1): E197-E206, 2020 10.
Artículo en Inglés | MEDLINE | ID: covidwho-817842

RESUMEN

Background Chest radiography has not been validated for its prognostic utility in evaluating patients with coronavirus disease 2019 (COVID-19). Purpose To analyze the prognostic value of a chest radiograph severity scoring system for younger (nonelderly) patients with COVID-19 at initial presentation to the emergency department (ED); outcomes of interest included hospitalization, intubation, prolonged stay, sepsis, and death. Materials and Methods In this retrospective study, patients between the ages of 21 and 50 years who presented to the ED of an urban multicenter health system from March 10 to March 26, 2020, with COVID-19 confirmation on real-time reverse transcriptase polymerase chain reaction were identified. Each patient's ED chest radiograph was divided into six zones and examined for opacities by two cardiothoracic radiologists, and scores were collated into a total concordant lung zone severity score. Clinical and laboratory variables were collected. Multivariable logistic regression was used to evaluate the relationship between clinical parameters, chest radiograph scores, and patient outcomes. Results The study included 338 patients: 210 men (62%), with median age of 39 years (interquartile range, 31-45 years). After adjustment for demographics and comorbidities, independent predictors of hospital admission (n = 145, 43%) were chest radiograph severity score of 2 or more (odds ratio, 6.2; 95% confidence interval [CI]: 3.5, 11; P < .001) and obesity (odds ratio, 2.4 [95% CI: 1.1, 5.4] or morbid obesity). Among patients who were admitted, a chest radiograph score of 3 or more was an independent predictor of intubation (n = 28) (odds ratio, 4.7; 95% CI: 1.8, 13; P = .002) as was hospital site. No significant difference was found in primary outcomes across race and ethnicity or those with a history of tobacco use, asthma, or diabetes mellitus type II. Conclusion For patients aged 21-50 years with coronavirus disease 2019 presenting to the emergency department, a chest radiograph severity score was predictive of risk for hospital admission and intubation. © RSNA, 2020 Online supplemental material is available for this article.


Asunto(s)
Infecciones por Coronavirus , Pulmón/diagnóstico por imagen , Pandemias , Neumonía Viral , Adulto , Betacoronavirus , Infecciones por Coronavirus/diagnóstico por imagen , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/patología , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Intubación Intratraqueal/estadística & datos numéricos , Pulmón/patología , Masculino , Persona de Mediana Edad , Neumonía Viral/diagnóstico por imagen , Neumonía Viral/epidemiología , Neumonía Viral/patología , Valor Predictivo de las Pruebas , Pronóstico , Radiografía Torácica , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , Adulto Joven
12.
Ann Emerg Med ; 76(4): 442-453, 2020 10.
Artículo en Inglés | MEDLINE | ID: covidwho-813454

RESUMEN

STUDY OBJECTIVE: The goal of this study is to create a predictive, interpretable model of early hospital respiratory failure among emergency department (ED) patients admitted with coronavirus disease 2019 (COVID-19). METHODS: This was an observational, retrospective, cohort study from a 9-ED health system of admitted adult patients with severe acute respiratory syndrome coronavirus 2 (COVID-19) and an oxygen requirement less than or equal to 6 L/min. We sought to predict respiratory failure within 24 hours of admission as defined by oxygen requirement of greater than 10 L/min by low-flow device, high-flow device, noninvasive or invasive ventilation, or death. Predictive models were compared with the Elixhauser Comorbidity Index, quick Sequential [Sepsis-related] Organ Failure Assessment, and the CURB-65 pneumonia severity score. RESULTS: During the study period, from March 1 to April 27, 2020, 1,792 patients were admitted with COVID-19, 620 (35%) of whom had respiratory failure in the ED. Of the remaining 1,172 admitted patients, 144 (12.3%) met the composite endpoint within the first 24 hours of hospitalization. On the independent test cohort, both a novel bedside scoring system, the quick COVID-19 Severity Index (area under receiver operating characteristic curve mean 0.81 [95% confidence interval {CI} 0.73 to 0.89]), and a machine-learning model, the COVID-19 Severity Index (mean 0.76 [95% CI 0.65 to 0.86]), outperformed the Elixhauser mortality index (mean 0.61 [95% CI 0.51 to 0.70]), CURB-65 (0.50 [95% CI 0.40 to 0.60]), and quick Sequential [Sepsis-related] Organ Failure Assessment (0.59 [95% CI 0.50 to 0.68]). A low quick COVID-19 Severity Index score was associated with a less than 5% risk of respiratory decompensation in the validation cohort. CONCLUSION: A significant proportion of admitted COVID-19 patients progress to respiratory failure within 24 hours of admission. These events are accurately predicted with bedside respiratory examination findings within a simple scoring system.


Asunto(s)
Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/diagnóstico , Servicio de Urgencia en Hospital , Neumonía Viral/complicaciones , Neumonía Viral/diagnóstico , Insuficiencia Respiratoria/virología , Índice de Severidad de la Enfermedad , Adolescente , Adulto , Anciano , Betacoronavirus , Técnicas de Laboratorio Clínico , Infecciones por Coronavirus/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Terapia por Inhalación de Oxígeno , Pandemias , Neumonía Viral/terapia , Insuficiencia Respiratoria/terapia , Estudios Retrospectivos , Medición de Riesgo/métodos , Adulto Joven
13.
Am J Case Rep ; 21: e927812, 2020 Oct 03.
Artículo en Inglés | MEDLINE | ID: covidwho-811592

RESUMEN

BACKGROUND This is a case report of an immunocompromised patient with a history of non-Hodgkin lymphoma and persistent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection who was seronegative and successfully treated with convalescent plasma. CASE REPORT A 63-year-old woman with a past medical history of non-Hodgkin lymphoma in remission while on maintenance therapy with the anti-CD20 monoclonal antibody, obinutuzumab, tested positive for SARS-CoV-2 via nasopharyngeal reverse transcription polymerase chain reaction (RT-PCR) testing over 12 weeks and persistently tested seronegative for immunoglobulin G (IgG) antibodies using SARS-CoV-2 IgG chemiluminescent microparticle immunoassay technology. During this time, the patient experienced waxing and waning of symptoms, which included fever, myalgia, and non-productive cough, but never acquired severe respiratory distress. She was admitted to our hospital on illness day 88, and her symptoms resolved after the administration of convalescent plasma. CONCLUSIONS As the understanding of the pathogenesis of SARS-CoV-2 continues to evolve, we can currently only speculate about the occurrence of chronic infection vs. reinfection. The protective role of antibodies and their longevity against SARS-CoV-2 remain unclear. Since humoral immunity has an integral role in SARS-CoV-2 infection, various phase 3 vaccine trials are underway. In the context of this pandemic, the present case demonstrates the challenges in our understanding of testing and treating immunocompromised patients.


Asunto(s)
Anticuerpos Monoclonales Humanizados/administración & dosificación , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/diagnóstico , Huésped Inmunocomprometido , Linfoma no Hodgkin/inmunología , Neumonía Viral/complicaciones , Neumonía Viral/diagnóstico , Antineoplásicos Inmunológicos/administración & dosificación , Técnicas de Laboratorio Clínico/métodos , Infecciones por Coronavirus/terapia , Femenino , Estudios de Seguimiento , Humanos , Inmunización Pasiva/métodos , Linfoma no Hodgkin/complicaciones , Linfoma no Hodgkin/tratamiento farmacológico , Persona de Mediana Edad , Pandemias , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Pruebas Serológicas/métodos , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
14.
J Infect Dis ; 222(8): 1265-1269, 2020 09 14.
Artículo en Inglés | MEDLINE | ID: covidwho-811305

RESUMEN

We determined and compared the humoral immune response in patients with severe (hospitalized) and mild (nonhospitalized) coronavirus disease 2019 (COVID-19). Patients with severe disease (n = 38) develop a robust antibody response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including immunoglobulin G and immunoglobulin A antibodies. The geometric mean 50% virus neutralization titer is 1:240. SARS-CoV-2 infection was found in hospital personnel (n = 24), who developed mild symptoms necessitating leave of absence and self-isolation, but not hospitalization; 75% developed antibodies, but with low/absent virus neutralization (60% with titers <1:20). While severe COVID-19 patients develop a strong antibody response, mild SARS-CoV-2 infections induce a modest antibody response. Long-term monitoring will show whether these responses predict protection against future infections.


Asunto(s)
Anticuerpos Antivirales/inmunología , Betacoronavirus/inmunología , Infecciones por Coronavirus/inmunología , Neumonía Viral/inmunología , Anticuerpos Antivirales/sangre , Formación de Anticuerpos , Betacoronavirus/aislamiento & purificación , Estudios de Cohortes , Infecciones por Coronavirus/sangre , Infecciones por Coronavirus/virología , Ensayo de Inmunoadsorción Enzimática , Humanos , Inmunoglobulina A/sangre , Inmunoglobulina A/inmunología , Inmunoglobulina G/sangre , Inmunoglobulina G/inmunología , Pruebas de Neutralización , Pandemias , Neumonía Viral/sangre , Neumonía Viral/virología , Índice de Severidad de la Enfermedad
15.
BMC Med Imaging ; 20(1): 111, 2020 10 02.
Artículo en Inglés | MEDLINE | ID: covidwho-810440

RESUMEN

BACKGROUND: To develop and validate a nomogram for early identification of severe coronavirus disease 2019 (COVID-19) based on initial clinical and CT characteristics. METHODS: The initial clinical and CT imaging data of 217 patients with COVID-19 were analyzed retrospectively from January to March 2020. Two hundred seventeen patients with 146 mild cases and 71 severe cases were randomly divided into training and validation cohorts. Independent risk factors were selected to construct the nomogram for predicting severe COVID-19. Nomogram performance in terms of discrimination and calibration ability was evaluated using the area under the curve (AUC), calibration curve, decision curve, clinical impact curve and risk chart. RESULTS: In the training cohort, the severity score of lung in the severe group (7, interquartile range [IQR]:5-9) was significantly higher than that of the mild group (4, IQR,2-5) (P < 0.001). Age, density, mosaic perfusion sign and severity score of lung were independent risk factors for severe COVID-19. The nomogram had a AUC of 0.929 (95% CI, 0.889-0.969), sensitivity of 84.0% and specificity of 86.3%, in the training cohort, and a AUC of 0.936 (95% CI, 0.867-1.000), sensitivity of 90.5% and specificity of 88.6% in the validation cohort. The calibration curve, decision curve, clinical impact curve and risk chart showed that nomogram had high accuracy and superior net benefit in predicting severe COVID-19. CONCLUSION: The nomogram incorporating initial clinical and CT characteristics may help to identify the severe patients with COVID-19 in the early stage.


Asunto(s)
Infecciones por Coronavirus/diagnóstico por imagen , Pulmón/diagnóstico por imagen , Nomogramas , Neumonía Viral/diagnóstico por imagen , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Área Bajo la Curva , Niño , Diagnóstico Precoz , Humanos , Persona de Mediana Edad , Pandemias , Distribución Aleatoria , Estudios Retrospectivos , Sensibilidad y Especificidad , Índice de Severidad de la Enfermedad , Tomografía Computarizada por Rayos X , Adulto Joven
16.
Trials ; 21(1): 827, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: covidwho-810387

RESUMEN

OBJECTIVES: We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment. TRIAL DESIGN: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study. PARTICIPANTS: Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2. Clinical stages of mild-to-moderate COVID-19 3. Symptomatic 4. ≥ 20 years of age 5. Male or female 6. Ability to communicate in Japanese 7. Outpatients and inpatients 8. Provided informed consent Exclusion criteria: 1. Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptoms 2. Allergic to Kampo or Western medicines used in this study 3. Pregnant and lactating 4. Unable to follow up 5. Participating in another clinical trial or interventional study 6. Hypokalemic or taking oral furosemide or steroids 7. Determined unsuitable for this study by the physician INTERVENTION AND COMPARATOR: Patients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives for symptoms that occurred after they contracted the SARS-CoV-2 infection. Patients in the Kampo group will receive 2.5 g of KT (TJ-1@TSUMURA and Co.) and 2.5 g of SSKKS (TJ-109@TSUMURA and Co.) 3 times a day, orally, for 14 days in addition to the conventional treatment as mentioned above. MAIN OUTCOMES: The number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath) improves in the first 14 days of treatment. To assess the cough, sputum, malaise, and shortness of breath, a numeric rating scale will be used to define improvement in terms of a 2-point decrease in the number of days from the start of treatment for at least 2 days. Fever will be defined as an improvement when the temperature is less than 37 °C. RANDOMIZATION: Patients are randomized (1:1 ratio) to each group using the minimization method, with balancing of the arms with severity of disease stage and patient age (< 65, 65 to < 75, or ≥ 75 years). Computer-generated random numbers will be used for the minimization method. BLINDING (MASKING): Open-label with no blinding NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The main research hypothesis of this study is that the combination of Kampo medicine and conventional treatment will significantly improve the patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath) during the first 14 days of treatment as compared with conventional treatment alone. Concerning the analysis of the primary endpoint, the duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath) will be estimated using the Kaplan-Meier method, and the survival curves will be compared between groups using the log-rank test. Assuming this method of analysis and based on previous studies reporting the efficacy of Kampo medicine for COVID-19 and H1N1 influenza patients, the median survival time in the Kampo medicine group is estimated as 3 days; this time will be 1.5 times longer in the control group. Assuming a one-sided significance level of 5%, a power of 70%, and an allocation ratio of 1:1, the required sample size is calculated as 126 cases. To compensate for a loss in follow-up, we plan to include 150 cases in both groups (Kampo group = 75, control group = 75). TRIAL STATUS: Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Antivirales/uso terapéutico , Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Medicina Kampo , Neumonía Viral/tratamiento farmacológico , Antivirales/efectos adversos , Betacoronavirus/patogenicidad , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/virología , Quimioterapia Combinada , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Interacciones Huésped-Patógeno , Humanos , Japón , Masculino , Estudios Multicéntricos como Asunto , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/virología , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento
17.
PLoS One ; 15(10): e0239802, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-810230

RESUMEN

BACKGROUND: To date, several clinical laboratory parameters associated with Coronavirus disease 2019 (COVID-19) severity have been reported. However, these parameters have not been observed consistently across studies. The aim of this review was to assess clinical laboratory parameters which may serve as markers or predictors of severe or critical COVID-19. METHODS AND FINDINGS: We conducted a systematic search of MEDLINE, Embase, Web of Science, CINAHL and Google Scholar databases from 2019 through April 18, 2020, and reviewed bibliographies of eligible studies, relevant systematic reviews, and the medRxiv pre-print server. We included hospital-based observational studies reporting clinical laboratory parameters of confirmed cases of COVID-19 and excluded studies having large proportions (>10%) of children and pregnant women. Two authors independently carried out screening of articles, data extraction and quality assessment. Meta-analyses were done using random effects model. Meta-median difference (MMD) and 95% confidence interval (CI) was calculated for each laboratory parameter. Forty-five studies in 6 countries were included. Compared to non-severe COVID-19 cases, severe or critical COVID-19 was characterised by higher neutrophil count (MMD: 1.23 [95% CI: 0.58 to 1.88] ×109 cells/L), and lower lymphocyte, CD4 and CD8 T cell counts with MMD (95% CI) of -0.39 (-0.47, -0.31) ×109 cells/L, -204.9 (-302.6, -107.1) cells/µl and -123.6 (-170.6, -76.6) cells/µl, respectively. Other notable results were observed for C-reactive protein (MMD: 36.97 [95% CI: 27.58, 46.35] mg/L), interleukin-6 (MMD: 17.37 [95% CI: 4.74, 30.00] pg/ml), Troponin I (MMD: 0.01 [0.00, 0.02] ng/ml), and D-dimer (MMD: 0.65 [0.45, 0.85] mg/ml). CONCLUSIONS: Relative to non-severe COVID-19, severe or critical COVID-19 is characterised by increased markers of innate immune response, decreased markers of adaptive immune response, and increased markers of tissue damage and major organ failure. These markers could be used to recognise severe or critical disease and to monitor clinical course of COVID-19.


Asunto(s)
Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/patología , Neumonía Viral/diagnóstico , Neumonía Viral/patología , Betacoronavirus , Proteína C-Reactiva/análisis , Productos de Degradación de Fibrina-Fibrinógeno/análisis , Humanos , Interleucina-6/sangre , Recuento de Linfocitos , Estudios Observacionales como Asunto , Pandemias , Índice de Severidad de la Enfermedad , Troponina I/sangre
18.
Zhonghua Jie He He Hu Xi Za Zhi ; 43(10): 834-838, 2020 Oct 12.
Artículo en Chino | MEDLINE | ID: covidwho-809893

RESUMEN

Objective: To investigate the application of severity classification according to the protocol on the Diagnosis and Treatment of coronavirus disease 2019(COVID-19)by the National Health Commission of China, pneumonia severity index(PSI) and CURB-65 in risk stratification and prognostic assessment of COVID-19. Methods: Clinical data of 234 in-hospital patients with COVID-19 were collected and retrospectively reviewed in Wuhan Tongji Hospital. Patients were divided into 3 groups (common, severe, and critical type) at admission according to the sixth version of the protocol issued by the National Health Commission of China on Diagnosis and Treatment of COVID-19. At the same time, the severity of pneumonia was calculated by PSI and CURB-65, and the patients were stratified into 3 risk groups, namely mild, moderate, and severe groups. The hospital mortality rate was evaluated in each group. Sensitivity, specificity, positive predictive values, negative predictive values, and the area under the receiver operating characteristic(ROC) curve(AUC) for predicting hospital mortality in each rule were assessed. Results: According to the severity classification of Chinese protocol, the proportion of patients with common type, severe type, and the critical type was 15.8%, 75.6%, and 8.5%, respectively. No in-hospital death occurred in the common type. As for PSI and CURB-65, greater proportions of patients were classified as low risk(79.1% and 75.6%, respectively), while smaller proportions of patients were classified as moderate and high risk(16.2%, 15.0%; 4.7%, 9.4%, respectively). In-hospital death occurred in low and moderate risk patients identified by these 2 scoring systems. The mortality of the critical group of the Chinese protocol was 65%, and the sensitivity and specificity of predicting in-hospital mortality were 36.4% and 97.0%, respectively. The mortality in the high risk group of PSI and CURB-65 was 100% and 77.3%. The risk class V of PSI and CURB-65 score 3-5 had high specificity(100% and 97.4%, respectively)but low sensitivity(33.3% and 51.5%, respectively)in predicting in-hospital mortality. The AUC of the Chinese protocol severity classification, PSI, and CURB-65 was 0.735, 0.951, and 0.912. The optimal cut-off point of PSI was risk class Ⅳ, and the sensitivity and specificity for predicting mortality were 90.9% and 90.5%. The optimal cut-off point of CURB-65 was score 2, and the corresponding sensitivity and specificity were 84.8% and 85.6%. Conclusions: PSI and CURB-65 can be used for risk stratification and prognostic assessment in patients with COVID-19.


Asunto(s)
Infecciones por Coronavirus/diagnóstico , Neumonía Viral/diagnóstico , Índice de Severidad de la Enfermedad , Betacoronavirus , China/epidemiología , Infecciones por Coronavirus/mortalidad , Humanos , Pandemias , Neumonía Viral/mortalidad , Pronóstico , Estudios Retrospectivos , Medición de Riesgo , Sensibilidad y Especificidad
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