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1.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-310922

ABSTRACT

Background: Patients with cancer have been shown to have a higher risk of clinical severity and mortality compared to non-cancer patients with COVID-19. Patients with hematologic malignancies typically are known to have higher levels of immunosuppression and may develop more severe respiratory viral infections than patients with solid tumours. Data on COVID-19 in patients with hematologic malignancies are limited. Here we characterise disease severity and mortality, and evaluate potential prognostic factors for mortality. Methods: In this population-based registry study, we collected de-identified data on clinical characteristics, treatment and outcomes in adult patients with hematologic malignancies and confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection within the Madrid region of Spain. Our case series included all patients admitted to 22 regional health service hospitals and 5 private healthcare centres between February 28 and May 25, 2020. The primary study outcome was all-cause mortality. We assessed the association between mortality and potential prognostic factors using Cox regression analyses adjusted for age, sex, comorbidities, hematologic malignancy and recent active cancer therapy. Results: Of 833 patients reported, 697 were included in the analyses. Median age was 72 years (IQR 60–79), 413 (60%) patients were male, and 479 (69%) and 218 (31%) had lymphoid and myeloid malignancies, respectively. Clinical severity of COVID-19 was severe/critical in 429 (62%) patients. At data cutoff, 230 (33%) patients had died. Age ≥60 years (hazard ratios 3·17–10·1 vs <50 years), >2 comorbidities (1·41 vs ≤2), acute myeloid leukemia (2·22 vs non-Hodgkin lymphoma) and active antineoplastic treatment with monoclonal antibodies (2·02) or conventional chemotherapy (1·50 vs no active therapy) were associated with increased mortality. Conversely, Ph-negative myeloproliferative neoplasms (0·33) and active treatment with hypomethylating agents (0·47) were associated with lower mortality. Overall, 574 (82%) patients received antiviral therapy. Mortality with severe/critical COVID-19 was higher with no therapy vs any antiviral combination therapy (2.20). Conclusions: In this series of patients with hematologic malignancies and COVID-19, mortality was associated with higher age, more comorbidities, type of hematological malignancy and type of antineoplastic therapy. Further studies and long-term follow-up are required to validate these criteria for risk-stratification.

2.
Thromb Haemost ; 122(2): 295-299, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1595734

ABSTRACT

Thromboprophylaxis with low molecular weight heparin in hospitalized patients with COVID-19 is mandatory, unless contraindicated. Given the links between inflammation and thrombosis, the use of higher doses of anticoagulants could improve outcomes. We conducted an open-label, multicenter, randomized, controlled trial in adult patients hospitalized with nonsevere COVID-19 pneumonia and elevated D-dimer. Patients were randomized to therapeutic-dose bemiparin (115 IU/kg daily) versus standard prophylaxis (bemiparin 3,500 IU daily), for 10 days. The primary efficacy outcome was a composite of death, intensive care unit admission, need of mechanical ventilation support, development of moderate/severe acute respiratory distress, and venous or arterial thrombosis within 10 days of enrollment. The primary safety outcome was major bleeding (International Society on Thrombosis and Haemostasis criteria). A prespecified interim analysis was performed when 40% of the planned study population was reached. From October 2020 to May 2021, 70 patients were randomized at 5 sites and 65 were included in the primary analysis; 32 patients allocated to therapeutic dose and 33 to standard prophylactic dose. The primary efficacy outcome occurred in 7 patients (22%) in the therapeutic-dose group and 6 patients (18%) in the prophylactic-dose (absolute risk difference 3.6% [95% confidence interval [CI], -16% -24%]; odds ratio 1.26 [95% CI, 0.37-4.26]; p = 0.95). Discharge in the first 10 days was possible in 66 and 79% of patients, respectively. No major bleeding event was registered. Therefore, in patients with COVID-19 hospitalized with nonsevere pneumonia but elevated D-dimer, the use of a short course of therapeutic-dose bemiparin does not appear to improve clinical outcomes compared with standard prophylactic doses. Trial Registration: ClinicalTrials.gov NCT04604327.


Subject(s)
COVID-19/drug therapy , Heparin, Low-Molecular-Weight/therapeutic use , Pneumonia/drug therapy , SARS-CoV-2/physiology , Aged , COVID-19/mortality , Female , Fibrin Fibrinogen Degradation Products/metabolism , Hospitalization , Humans , Male , Middle Aged , Pneumonia/mortality , Respiration, Artificial , Severity of Illness Index , Survival Analysis , Treatment Outcome
5.
Blood ; 136(Supplement 1):12-13, 2020.
Article in English | PMC | ID: covidwho-1338992

ABSTRACT

Peter Paschka and Hartmut Döhner contributed equally.Background. SARS-CoV-2 infection (COVID-19) has had a great impact worldwide and its mortality has been reported to be higher in patients with haematological malignancies. However, description of its effects and outcomes among recipient of hematopoietic stem cell transplantation (HSCT) is scarce.Objectives. To describe the characteristics, treatment and outcome of COVID-19 in recipients of HSCT reported to the Madrid registry of COVID-19 ("HEMATO-MADRID COVID-19 registry").Results. Data of 842 patients from 23 hospitals with haematological malignancies and COVID-19 infection were reported in the Madrid registry between March and June 2020. Among those, 87 (10.3%) patients were HSCT recipients: 58 auto-HSCT and 29 allo-HSCT (7 of them from matched related donor (MRD), 12 matched unrelated donor (MUD) and 10 haplo-HSCT). Characteristics of the population are described in Table 1. Median age at COVID-19 infection was 61 years (IQR, 53-67) and 35 patients (40%) were female. Recipients of auto-HSCT with COVID-19 were older and showed a trend towards a higher incidence of arterial hypertension (28% vs 10%, p=0.067) without statistical differences in other comorbidities;active disease requiring treatment at COVID-19 diagnosis was more frequent in auto-HSCT recipients (65% vs. 21%, p<0.001). Median time from transplant to COVID19 infection was shorter in allo-HSCT patients (32 vs. 19 months, p=0.043). Nearly 40% of allo-recipients had active GVHD at COVID-19 debut, including pulmonary GVHD. A total of 63 (72%) patients required hospital admission and 13 patients (15%) received intensive care support. Allo-recipients showed a trend towards a higher need of hospital admission (79% vs. 68%, p=0.081). Most patients received anti-viral treatment with either hydroxichloroquine (47 patients, 54%), lopinavir/ritonavir (34 patients, 39%), remdesivir (5, 4%) and/or other treatments including azythromicin or interferon. 23 patients (26%) received anticytokine treatment with tocilizumab (15, 17%) and/or anakinra (8, 9%) and 27 patients (31%) received steroids. The overall response rate to treatment and supportive care was 80% in both groups. After a median follow-up of 50 days after the infection debut, overall-survival at day 50 was 84% for auto and 82% for allo-HSCT recipients (p=0.915). However, global mortality rate among the complete observation period was significantly higher in allo-recipients (24% vs. 17%, p <0.001).Conclusion. In our multicentric experience in a high COVID-19 impacted area, the median time of COVID-19 infection presentation was relatively late in transplanted patients, however shorter in allo-transplanted patients. COVID-19 related mortality was high in HSCT recipients, significantly higher in allo-transplanted patients. Factors associated to this higher mortality should be further investigated to promptly identify high-risk patients since the pandemic is still highly active worldwide.

6.
J Thromb Haemost ; 19(8): 1981-1989, 2021 08.
Article in English | MEDLINE | ID: covidwho-1238451

ABSTRACT

INTRODUCTION: Some local protocols suggest using intermediate or therapeutic doses of anticoagulants for thromboprophylaxis in hospitalized patients with coronavirus disease 2019 (COVID-19). However, the incidence of bleeding, predictors of major bleeding, or the association between bleeding and mortality remain largely unknown. METHODS: We performed a cohort study of patients hospitalized for COVID-19 that received intermediate or therapeutic doses of anticoagulants from March 25 to July 22, 2020, to identify those at increased risk for major bleeding. We used bivariate and multivariable logistic regression to explore the risk factors associated with major bleeding. RESULTS: During the study period, 1965 patients were enrolled. Of them, 1347 (69%) received intermediate- and 618 (31%) therapeutic-dose anticoagulation, with a median duration of 12 days in both groups. During the hospital stay, 112 patients (5.7%) developed major bleeding and 132 (6.7%) had non-major bleeding. The 30-day all-cause mortality rate for major bleeding was 45% (95% confidence interval [CI]: 36%-54%) and for non-major bleeding 32% (95% CI: 24%-40%). Multivariable analysis showed increased risk for in-hospital major bleeding associated with D-dimer levels >10 times the upper normal range (hazard ratio [HR], 2.23; 95% CI, 1.38-3.59), ferritin levels >500 ng/ml (HR, 2.01; 95% CI, 1.02-3.95), critical illness (HR, 1.91; 95% CI, 1.14-3.18), and therapeutic-intensity anticoagulation (HR, 1.43; 95% CI, 1.01-1.97). CONCLUSIONS: Among patients hospitalized with COVID-19 receiving intermediate- or therapeutic-intensity anticoagulation, a major bleeding event occurred in 5.7%. Use of therapeutic-intensity anticoagulation, critical illness, and elevated D-dimer or ferritin levels at admission were associated with increased risk for major bleeding.


Subject(s)
COVID-19 , Venous Thromboembolism , Anticoagulants/adverse effects , Cohort Studies , Humans , Retrospective Studies , SARS-CoV-2
7.
Semin Thromb Hemost ; 47(4): 351-361, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-885548

ABSTRACT

Venous thromboembolism (VTE) is common in patients with coronavirus disease-2019 (COVID-19). However, limited data exist on patient characteristics, treatments, and outcomes. To describe the clinical characteristics, treatment patterns, and short-term outcomes of patients diagnosed with VTE during hospitalization for COVID-19. This is a prospective multinational study of patients with incident VTE during the course of hospitalization for COVID-19. Data were obtained from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry. All-cause mortality, VTE recurrences, and major bleeding during the first 10 days were separately investigated for patients in hospital wards versus those in intensive care units (ICUs). As of May 03, 2020, a total number of 455 patients were diagnosed with VTE (83% pulmonary embolism, 17% isolated deep vein thrombosis) during their hospital stay; 71% were male, the median age was 65 (interquartile range, 55-74) years. Most patients (68%) were hospitalized in medical wards, and 145 in ICUs. Three hundred and seventeen (88%; 95% confidence interval [CI]: 84-91%) patients were receiving thromboprophylaxis at the time of VTE diagnosis. Most patients (88%) received therapeutic low-molecular-weight heparin, and 15 (3.6%) received reperfusion therapies. Among 420 patients with complete 10-day follow-up, 51 (12%; 95% CI: 9.3-15%) died, no patient recurred, and 12 (2.9%; 95% CI: 1.6-4.8%) experienced major bleeding. The 10-day mortality rate was 9.1% (95% CI: 6.1-13%) among patients in hospital wards and 19% (95% CI: 13-26%) among those in ICUs. This study provides characteristics and early outcomes of patients diagnosed with acute VTE during hospitalization for COVID-19. Additional studies are needed to identify the optimal strategies to prevent VTE and to mitigate adverse outcomes associated.


Subject(s)
COVID-19 , Heparin, Low-Molecular-Weight/administration & dosage , Hospital Mortality , Registries , Venous Thromboembolism , Adult , Aged , Aged, 80 and over , COVID-19/complications , COVID-19/diagnosis , COVID-19/mortality , COVID-19/therapy , Female , Follow-Up Studies , Hemorrhage/etiology , Hemorrhage/mortality , Hemorrhage/therapy , Humans , Male , Middle Aged , Prospective Studies , SARS-CoV-2 , Venous Thromboembolism/diagnosis , Venous Thromboembolism/etiology , Venous Thromboembolism/mortality , Venous Thromboembolism/therapy
8.
J Hematol Oncol ; 13(1): 133, 2020 10 08.
Article in English | MEDLINE | ID: covidwho-840891

ABSTRACT

BACKGROUND: Patients with cancer have been shown to have a higher risk of clinical severity and mortality compared to non-cancer patients with COVID-19. Patients with hematologic malignancies typically are known to have higher levels of immunosuppression and may develop more severe respiratory viral infections than patients with solid tumors. Data on COVID-19 in patients with hematologic malignancies are limited. Here we characterize disease severity and mortality and evaluate potential prognostic factors for mortality. METHODS: In this population-based registry study, we collected de-identified data on clinical characteristics, treatment and outcomes in adult patients with hematologic malignancies and confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection within the Madrid region of Spain. Our case series included all patients admitted to 22 regional health service hospitals and 5 private healthcare centers between February 28 and May 25, 2020. The primary study outcome was all-cause mortality. We assessed the association between mortality and potential prognostic factors using Cox regression analyses adjusted for age, sex, comorbidities, hematologic malignancy and recent active cancer therapy. RESULTS: Of 833 patients reported, 697 were included in the analyses. Median age was 72 years (IQR 60-79), 413 (60%) patients were male and 479 (69%) and 218 (31%) had lymphoid and myeloid malignancies, respectively. Clinical severity of COVID-19 was severe/critical in 429 (62%) patients. At data cutoff, 230 (33%) patients had died. Age ≥ 60 years (hazard ratios 3.17-10.1 vs < 50 years), > 2 comorbidities (1.41 vs ≤ 2), acute myeloid leukemia (2.22 vs non-Hodgkin lymphoma) and active antineoplastic treatment with monoclonal antibodies (2·02) were associated with increased mortality; conventional chemotherapy showed borderline significance (1.50 vs no active therapy). Conversely, Ph-negative myeloproliferative neoplasms (0.33) and active treatment with hypomethylating agents (0.47) were associated with lower mortality. Overall, 574 (82%) patients received antiviral therapy. Mortality with severe/critical COVID-19 was higher with no therapy vs any antiviral combination therapy (2.20). CONCLUSIONS: In this series of patients with hematologic malignancies and COVID-19, mortality was associated with higher age, more comorbidities, type of hematological malignancy and type of antineoplastic therapy. Further studies and long-term follow-up are required to validate these criteria for risk stratification.


Subject(s)
Antineoplastic Agents/therapeutic use , Coronavirus Infections/complications , Coronavirus Infections/epidemiology , Hematologic Neoplasms/complications , Hematologic Neoplasms/drug therapy , Pneumonia, Viral/complications , Pneumonia, Viral/epidemiology , Registries , Severity of Illness Index , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Antineoplastic Agents/adverse effects , Antiviral Agents/therapeutic use , Betacoronavirus , COVID-19 , Comorbidity , Coronavirus Infections/drug therapy , Coronavirus Infections/mortality , Female , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/drug therapy , Pneumonia, Viral/mortality , Prospective Studies , Risk Factors , SARS-CoV-2 , Spain/epidemiology , Treatment Outcome , Young Adult
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