ABSTRACT
Introduction: The Age-related DeVelopments ANd Comorbidities in haemophilia (ADVANCE) Working Group is a European collaboration of over 20 Haemophilia Treatment Centres (HTCs) that focuses on the management of PWH aged >=40 years. As it soon became apparent that the risk of severe outcomes from COVID-19 infection was increased in older adults, we aimed to identify the incidence, severity and outcomes of COVID-19 inPWHaged >=40 years treated at ADVANCE centres. Method(s): The number of hospital admissions, ICU admissions and deaths due to COVID-19 was recorded retrospectively via survey for all patients aged >=40 years with haemophilia A or B at ADVANCE HTCs throughout the pandemic over a 24-month period (until 30 April 2022). Patient numbers were recorded for the most serious outcome at month/year of first occurrence. Aggregated data was provided as requested by Ethical Committees. For reported cases, information on age, comorbidities and risk factors for severeCOVID-19 infection were collected where available. Result(s): Of the overall haemophilia A and B population, 36/4166 suffered a serious outcome due to COVID-19 infection;27 required hospital admission, 5 were admitted to the ICU and 4 died (3 with haemophilia A and 1 with haemophilia B). Nearly all patients with haemophilia A who were admitted to the ICU or died had >=1 comorbidity associated with worse outcomes. Most reported cases occurred early in the pandemic with no clear distinction according to haemophilia severity or age. Discussion/Conclusion: This is the first study to evaluate the impact of the pandemic on PWH >=40 years in terms of severe adverse clinical outcomes. Although only limited data were collected, the study provides reassurance that the haemophilia population was not at risk of more serious outcomes due to their haemophilia alone.
ABSTRACT
We do not know the precise figure for solid organ tumors diagnosed each year in Spain and it is therefore difficult to calculate whether there has been a decrease in cancer diagnoses as a consequence of the pandemic. Some indirect data suggest that the pandemic has worsened the stage at which some non-hematological neoplasms are diagnosed. Despite the lack of robust evidence, oncology patients seem more likely to have a poor outcome when they contract COVID-19. The antibody response to infection in cancer patients will be fundamentally conditioned by the type of neoplasia present, the treatment received and the time of its administration. In patients with hematological malignancies, the incidence of infection is probably similar or lower than in the general population, due to the better protective measures adopted by the patients and their environment. The severity and mortality of COVID-19 in patients with hematologic malignancies is clearly higher than the general population. Since the immune response to vaccination in hematologic patients is generally worse than in comparable populations, alternative methods of prevention must be established in these patients, as well as actions for earlier diagnosis and treatment. Campaigns for the early diagnosis of malignant neoplasms must be urgently resumed, post-COVID manifestations should be monitored, collaboration with patient associations is indisputable and it is urgent to draw the right conclusions to improve our preparedness to fight against possible future catastrophes.
ABSTRACT
Introduction: The severity of acute clinical outcomes and mortality in hematologic malignancy (HM) patients infected by SARS-CoV-2 was exhaustively documented in the first weeks of the pandemic. A consistent increased mortality compared to non-cancer patients was observed across studies. In this study we aimed to estimate survival in COVID-19 HM patients by type of malignancy, to describe acute and post-acute clinical outcomes, and to compare outcomes in early and later pandemic periods. Methods: In this population-based registry study sponsored by the Madrid Society of Hematology (Asociación Madrileña de Hematología y Hemoterapia), we collected de-identified data on clinical characteristics, treatment and acute and post-acute outcomes in adult patients with hematologic malignancies and confirmed SARS-CoV-2 infection within the Madrid region of Spain. Our case series included all eligible patients admitted to 26 regional health service hospitals and 5 private healthcare centers between February 28, 2020 and February 18, 2021 with a coverage of 98% on a population of 6.6 million inhabitants. The study outcomes were all-cause mortality, severity of disease (WHO), oxygen support, ICU admission, and follow-up symptoms and signs and complications. Survival probabilities were estimated with the actuarial method and reported overall and stratified by type of malignancy and for two study periods (early cohort,-COVID-19 diagnosis from February 28 to 31 May, 2020, and later cohort, up to February 18, 2021). Results: Of the 1408 patients reported to the HEMATO-MADRID COVID-19 registry, 1166 were included in the present analyses;839 (72%) had a lymphoid malignancy, including 325 (28%) with non-Hodgkin lymphoma, 50 (4%) with Hodgkin lymphoma and 263 (23%) with multiple myeloma;and 327 (28%) had a myeloid malignancy, including 115 (10%) with myelodysplastic syndrome, 92 (8%) with acute myeloid leukemia (AML) and 87 (7%) with Philadelphia chromosome (Ph)-negative myeloproliferative neoplasms. Overall COVID-19 clinical severity was classified as critical in 19% of patients, severe in 36%, moderate in 22%, and mild in 22%;10% were admitted to an ICU;8% were on mechanical ventilation and 19% on noninvasive ventilation. Mild disease increased between early and later period from 15% to 38% of patients;severe disease decreased from 42% to 24%, p<0.001. COVID-19 treatment with steroids increased from 38% to 59%, p<0.001. At follow-up, 22% reported persistent symptoms related to COVID-19 at 2 months, 16% at 4 months and 14% at 6 months. 381 of 1166 (33%) patients died. Overall 30-day survival was 68%;2 and 3-month overall survival probabilities were 56% and 53%, respectively. Survival was more favorable for patients with myeloproliferative neoplasms (82%, 69% and 65% at 30-days, 2 and 3 months, respectively) than for those with lymphoid malignancies (68%, 56% and 54%) or myelodysplastic syndrome/acute myeloid leukemia (61%, 51%, 46%), p=001. 285 (37%) patients died in the early period vs 96 (24%) in the later, p<0.001, but median (interquartile range) follow-up time was much higher in the early vs later, 45 (20-116) days vs. 26 (11-86), respectively. Overall survival was not different between periods, p=0.5 (hazard ratio [95%C], 0.93 [0.73-1.17]). In the later cohort, 30 and 60-day survival probabilities were 71% and 56% vs. 67% and 56% in the early cohort Conclusions. A population-based registry in Spain provided strong evidence that although COVID-19 severity decreased over year 1 of the pandemic, mortality remained high, and survival was stable over time in the group of patients with hematological malignancy infected by SARS-Coc-2. A relevant proportion of the infected patients (1 in 6) referred persistent symptoms attributable to COVID-19. The improved clinical management of severe COVID-19 in non-cancer patients that followed the dissemination of evidence-based recommendations did not translate in more favorable survival in patients with hematological malignancies. Research is needed to address the specific characteristics nd improve the clinical management of this vulnerable population. Disclosures: Martinez-Lopez: Novartis: Consultancy, Speakers Bureau;BMS: Consultancy, Research Funding, Speakers Bureau;Janssen: Consultancy, Speakers Bureau;Incyte: Consultancy, Research Funding, Speakers Bureau;Roche: Consultancy, Research Funding, Speakers Bureau;Astellas: Research Funding, Speakers Bureau. Jiménez-Yuste: Pfizer: Consultancy, Honoraria, Research Funding;Grifols: Consultancy, Honoraria, Research Funding;CSL Behring: Consultancy, Honoraria, Research Funding;Sanofi: Consultancy, Honoraria, Research Funding;Bayer: Consultancy, Honoraria, Research Funding;NovoNordisk: Consultancy, Honoraria, Research Funding;BioMarin: Consultancy;Sobi: Consultancy, Honoraria, Research Funding;Octapharma: Consultancy, Honoraria, Research Funding;Takeda: Consultancy, Honoraria, Research Funding;F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Research Funding. Kwon: Gilead: Honoraria.
ABSTRACT
Introduction: The pandemic has affected various levels of health assistance and we have to wait to know all the aspects that COVID-19 has entailed. Surgeries, rehabilitation, teaching programs, inclusion in clinical trials, pharmacokinetics (PKs), and expanded coagulation studies were suspended. Since next working day after lockdown we organized assistance through teleconferences with the staff working onsite, Clinical Research Associates (CRA) and sponsors, Patient's Association and with people with hemophilia and their caregivers. Also, we had to deal with the stop in 3 trials affecting 5 patients. Our Clinical Trials Unit (CTU) has 2 study nurses, 1 study coordinator, 4 hematologist investigators and 4 researchers, having 59 clinical trials and observational studies open, with more than 200 patients. Our aim is to identify the non-priority procedures affected Methods: We evaluated the assistance provided by the CTU of Hospital Universitario La Paz, from February to September. Assistance was categorized as priority procedures (administration of treatment, urgencies, telephonic follow-up visits and home deliveries of treatment) and non-priority procedures (PKs, onsite follow-up visits, screening/baselines, monitoring visits by CRAs and health education using apps/devices) Results: Since March 16th only 3 of 11 members of the CTU were onsite, 2 of them attending patients with COVID-19 outside our Unit. We performed 17 priority procedures and 0 non-priority. In April, we started going one day/week alternating between staff members. We performed 9 priority procedures and 0 non-priority procedures. In May, we started going twice/week, alternating staff members and performing 26 priority procedures (13 with home delivered treatment) and 4 non-priority procedures. In June, all the staff began to work onsite performing 14 priority procedures and 10 non-priority procedures. During holiday with less staff onsite, we performed 5 priority procedures and 29 non-priority procedures. In September, all staff were working onsite and we performed 3 priority procedures and 38 non-priority Discussion/Conclusion: Only in 2 of the 6 months of observation the whole staff from the CTU was onsite. This stopped and delayed non-priority procedures very important for diagnosis and management. We spent 3 months without performing a single PK, screening or baseline. We also have to consider that delays in clinical trials will affect the availability of products on the market.
ABSTRACT
The Hematology Department and its Hematopoietic Cell Transplantation (HCT) program implemented several measures during COVID-19 outbreak in order to keep clinical activities with the maximum security for both donors and recipients. Nevertheless, there was a lack of evidence whether blood products and specifically bone marrow can cause transfusion-transmitted infection. Initially, there were many uncertainties and did not exist formal recommendations. Before official statements were available, we performed an allogeneic HCT in a 57-year-old male from a related matched donor in the incubation period of COVID-19 where the patient did not develop the disease. Actual epidemiology data suggest that transmission may occur early in the course of infection, even from asymptomatic patients in the incubation period. In our knowledge this is the first case report of an adult hematopoietic cell donor with COVID-19 in the incubation period where the transplant is successfully completed with no transmission of SARS-CoV-2. The low concentration of viral RNA in plasma of patients with COVID-19 could support the safety of blood products, including peripheral blood hematopoietic cells. In conclusion, blood products including hematopoietic stem cells are safe in the context of COVID-19 pandemic.