ABSTRACT
Background: Research on the impact of COVID-19 on different patient populations has been of great value for the optimization of patient care since the start of the SARS-CoV-2 pandemic. Earlier, we reported the interim analysis of the immediate outcomes in patients (pts) with hematologic (hem) disease and COVID-19. Long-term results of the CHRONOS19 registry are now available. Methods: CHRONOS19 is an observational prospective cohort study among adult pts ((≥18 years) with hem diseases (malignant or non-malignant) and laboratory-confirmed or suspected (based on clinical symptoms and/or CT) COVID-19 in Russia. Data from 15 centers all over the country were collected on a web-based platform in a de-identified manner at 30, 90, and 180 days after COVID-19 was diagnosed. The primary endpoint was 30-day all-cause mortality. Secondary outcomes included COVID-19 complications, rate of ICU admission and mechanical ventilation, outcomes of hem disease in SARS-CoV-2 infected pts, overall survival, and risk factors for disease severity and mortality. Results: As of July 30, 2021, 666 pts were enrolled (females / males [n (%)]: 317 (48%) / 349 (52%);median [range] age: 56 [18-90] years. Disease types (malignant/non-malignant [n (%)]): 618 (93%) / 48 (7%), including AML 115 (17%), MM 113 (17%), NHL 106 (16%), CML / CMPD 92 (14%), ALL 52 (8%), CLL 50 (8%), MDS 25 (4%), HCL 23 (3%), HL 21 (3%), AA 16 (2%), APL 11 (2%), others 42 (6%);among them induction phase / remission / relapse or refractory / NA in 237 (35%) / 231 (35%) / 152 (23%) / 46 (7%) pts. Concomitant conditions were reported in 385 (58%) pts: cardiovascular 254 (66%), diabetes 76 (20%), obesity 57 (15%), pulmonary 41 (11%), chronic renal 44 (11%) or hepatic 33 (9%) disease, other 90 (23%). At a median follow-up of 7,5(1-19) months, 618 pts were evaluable for the primary outcome. Thirty-day all-cause mortality was 16% (100 pts died). Death due to COVID-19 complications occurred in 82 pts, 14 pts died due to progression of hem disease. Overall, 217 (33%) pts had severe disease, COVID-19 complications were detected in 458 (70%) pts, the most common were pneumonia in 425 (93%) pts, respiratory failure in 252 (55%) pts, multiple organ failure in 56 (12%) pts, cytokine storm in 52 (11%) pts, ARDS in 47 (10%) pts, and sepsis in 44 (10%) pts. The rate of ICU admission was 23% (145 pts) with high mortality in this group of pts (77%), 111 (17%) pts required mechanical ventilation, among them only 5 (4.5%) pts survived. Treatment of hem disease was changed, interrupted, or discontinued in 395 (60%) pts with a median delay of 4 weeks. At 30 days, the rate of relapse / progression of hem disease was 5% / 8% (24 / 40 of 517 evaluable pts). At the longer follow-up (90 and 180 days), relapse / progression occurred in another 9 / 23 pts. At the data cutoff, the median overall survival was not reached. Antibody detection was performed in 253 pts: 211 (84%) pts had IgG to SARS-CoV-2. In a univariate analysis, older age (> 60 years), myelotoxic agranulocytosis, transfusion dependence, diabetes among comorbidities, ARDS and other complications, except CRS, ICU and mechanical ventilation (Fig. 1) were associated with higher risks of mortality (p<0.05). The final results of the CHRONOS19 study will be presented. Conclusions: Patients with hem disease and COVID-19 have higher mortality than a general population with SARS-CoV-2 infection, predominantly due to COVID-19 complications. The longer-term follow-up did not reveal any concerns in terms of hem disease outcomes. [Formula presented] Disclosures: Vorobyev: Janssen, Roche, Sanofi, Takeda, Biocad, Abbvie: Other: Advisory Boards, Speakers Bureau;Astellas, Novartis, AstraZeneca: Speakers Bureau. Chelysheva: Pharmstandart: Speakers Bureau;Pfizer: Speakers Bureau;Bristol Myers Squibb: Speakers Bureau;Novartis Pharma: Speakers Bureau.
ABSTRACT
Background: Patients (pts) with acute leukemia (AL) are at high risk of COVID-19 severe and lethal course. Intensive chemotherapy and immunosuppression in these patients are the possible causes of high mortality. Emerging data on risk factors and outcomes in this vulnerable patient population is aimed to support strategies of their medical care. Aims: To evaluate treatment outcomes and risk factors in pts with AL and COVID-19 in a real-world setting. Methods: CHRONOS19 [NCT04422470] is an ongoing nationwide observational cohort study of adult (≥18 y) pts with hematologic disease (both malignant and non-malignant) and lab-confirmed or suspected (based on clinical and/or CT findings) COVID-19. We performed a subgroup analysis of pts with AL and COVID-19. Primary objective was to evaluate treatment outcomes and identify risk factors associated with higher mortality in this group of pts. Primary endpoint was 30-day all-cause mortality. Long-term follow-up was performed at 90 and 180 days. Data from 14 centers was collected on a web-based platform and managed in a deidentified manner. Results: As of data cutoff on January 27, 2021, 575 pts were included in the registry, 132 of them with AL were eligible for primary endpoint assessment n(%): AML - 86(65%), ALL - 37(28%), APL - 9(7%);M/F 55(42%)/77(58%), median age 45 [18-79] years, induction phase/R/R/ treatment in remission 49(37%)/27(21%)/ 54(42%), agranulocytosis in 55(42%) pts, 68(53%) pts were transfusion dependent, comorbidities - in 58(45%) pts. Complications developed in 98(74%) pts: pneumonia (71%), sepsis (9%), CRS (8%), ARDS (6%). One-third of pts had severe COVID-19, 30% were admitted to ICU, 26% required mechanical ventilation. We performed comparative analysis of characteristics between a group of pts with AL and other hematologic diseases (lymphomas, chronic leukemia, multiple myeloma, and other malignant and non-malignant diseases): pts with AL had significantly more frequent agranulocytosis (42% vs 20%, p<0,001), transfusion dependence (53% vs 33%, p<0,001), and a higher rate of admission to ICU (30% vs 20%, p=0,036). All-cause mortality at 30 days was 24% in pts with AL vs. 15% in pts with other hematologic diseases (p=0,03);70% of deaths were due to COVID- 19 complications in pts with AL. At 90 days, one additional death due to COVID-19 occurred. At 180 days, 5 more deaths due to leukemia progression were registered. Risk factors that were significantly associated with overall survival (OS) are listed in Table 1. In multivariate analysis, ICU + mechanical ventilation, HR, 70.258 (19.5-270.0) and age >60 years HR, 3.340 (1.08-10.9) were the most significant risk factors of death. Overall, AL were associated with a higher risk of death, HR, 2.40 (1.28-4.51), compared to less aggressive diseases (CML, CLL, MM, lymphomas, non-malignant), HR, 0.54 (0.37-0.80). COVID-19 affected treatment of AL in 65% of pts, 58% experienced treatment delay for a median of 4 [1-10] weeks. In 11 of 103 (10,7%) pts with AL early relapse/refractory disease was detected, but the association of relapses with affected treatment is unknown. COVID-19 re-infection was described in 2 patients. Summary/Conclusion: Thirty-day all-cause mortality was significantly higher in SARS-CoV-2-infected pts with AL than in those with other hematologic diseases. Longer-term follow-up (180 days) for AL outcomes and OS will be presented.
ABSTRACT
Introduction. The SARS-CoV-2 infection (COronaVlrus Disease 2019, COVID-19) usually progresses uncomplicated in an acute respiratory form but causes frequent severe illness in oncohaematological patients. Aim analysis of the management and efficacy of medical aid at a haematology clinic during the COVID-19 pandemic. Patients. The clinic admitted 2,130 patients in April 20 November 20, 2020, with 920 of them triaged into observatory wards. At the time of admission, 907 (98.5 %) patients were SARS-CoV-2 RNA-negative, with 13 hospitalised without nasopharyngeal swab tests. Patient nosology: 235 (25.5 %) lymphoma, 152 (16.5 %) multiple myeloma, 131 (14.2 %) acute leucaemia, 86 (9.3 %) haemophilia, 35 (4 %) Gaucher's disease, 17 (1.8 %) Waldenstrom macroglobulinemia, 16 (1.7 %) aplastic anaemia, 153 (16.6 %) various surgical diseases, 81 (8.8 %) other haematological diseases and 14 (1.6 %) were bone marrow donors. Results. Among the 920 patients admitted to the observatory, 139 (15 %) were severe and 653 (71 %) had a moderate condition. Fever was reported in 124 (13.5 %) patients at admission. Chest computed tomography (CT) was performed in 809 patients, with recent lung inflammation detected in 121 (15 %) cases. Twenty four (2.6 %) patients were revealed SARS-CoV-2-positive, with 20 diagnoses PCR-verified and four in chest CT. Ten patients were diagnosed positive in routine examination or at a specialty unit as fever aggravated. Thus, a two -staged SARS-CoV-2 screening with PCR and chest CT allowed an extra 2.6 % detection of COVID-19 cases despite negative tests at admission. Conclusion. The observatory management has reduced the likelihood of nosocomial COVID-19 and ensured a continued supply of specialty medical aid.
ABSTRACT
Background: By 11/03/2020, the WHO had declared the COVID-19 outbreak a pandemic. At 25/05/2020 Russia ranked third by the incidence of COVID-19 and the number of confirmed cases was 344,481 with 3,541(1%) deaths. Aim: To describe the epidemiological characteristics and survival of patients with hematological diseases (HD) and COVID-19. Patients: Between 20/04/2020-25/05/2020, all hospitalized patients at NRCH were tested for COVID-19 before hospitalization and with once-weekly follow-up (or in case of fever). Nasal swab samples were studied by RT-PCR. The study population included 46 patients (pts) with HD and confirmed SARS-CoV-2. All pts were observed at ten departments. 15 pts who shared the same wards (3-4 patients in one ward) at one department were infected. Ten infected pts resided in single-bed wards and 21 pts were observed at the outpatient department. All pts with positive SARS-CoV-2 were treated either in COVID-19-specialized centers (29 (63%) pts) or at home (17 (37%) pts). Results: The most common symptom at the onset of illness was fever (26 (57%) pts), the other pts were asymptomatic. Pneumonia was diagnosed in 27 pts. All 17 pts who were treated at home recovered. Out of 8 pts who required treatment at the ICU, 5 pts died. Thirty-eight pts were treated without ICU (1 pt died due to sudden death). As of 25/05/2020, 10 out of 29 pts were still hospitalized. Totally, 13 pts were discharged, and 6 pts died. Out of the 8 pts who were admitted to the ICU, 1 pt was still at the ICU, 1 pt was discharged and returned home, 1 pt was transferred to the general wards, and 5 pts died. Six (13%) of 46 pts required IMV;of them, 5 pts died and 1 pt still remains. Conclusion: In this single-center analysis of 46 pts with HD and confirmed SARS-CoV-2, 1-month OS was 82%, the median follow-up was 18 days, and mortality was 13%. Compared to the general population with COVID-19 in Russia, the mortality in patients with HD was higher (13% vs 1%) with the comparable median age (40 vs 45 years). The COVID-19 pandemic dictates new epidemiological conditions for the management of pts with HD: mandatory SARS-CoV-19 testing in all pts before hospitalization followed by weekly testing, treatment in single-room wards and compliance with strict epidemiological measures.