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1.
Hematol Oncol ; 2022 Aug 06.
Article in English | MEDLINE | ID: covidwho-1976711

ABSTRACT

A multicenter retrospective study was designed to assess clinical outcome of COVID-19 in patients with hematological malignancies (HM) following treatment with anti-SARS-CoV-2 convalescent plasma (CP) or standard of care therapy. To this aim, a propensity score matching was used to assess the role of non-randomized administration of CP in this high-risk cohort of patients from the Italian Hematology Alliance on COVID-19 (ITA-HEMA-COV) project, now including 2049 untreated control patients. We investigated 30- and 90-day mortality, rate of admission to intensive care unit, proportion of patients requiring mechanical ventilatory support, hospitalization time, and SARS-CoV-2 clearance in 79 CP recipients and compared results with 158 propensity score-matched controls. Results indicated a lack of efficacy of CP in the study group compared with the untreated group, thus confirming the negative results obtained from randomized studies in immunocompetent individuals with COVID-19. In conclusion, this retrospective analysis did not meet the primary and secondary end points in any category of immunocompromized patients affected by HM.

2.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-305911

ABSTRACT

Background: During the coronavirus disease-2019 (COVID-19) pandemic, Italian hospitals faced the most daunting challenges of their recent history, and only essential therapeutic interventions were feasible. From March to April 2020, the Laboratory of Advanced Cellular Therapies (Vicenza, Italy) received requests to treat a patient with severe COVID-19 and a patient with acute graft- versus -host disease with umbilical cord-derived mesenchymal stromal cells (UC-MSCs). Access to clinics was restricted due to the risk of contagion. Transport of UC-MSCs in liquid nitrogen was unmanageable, leaving shipment in dry ice as the only option. Methods: We assessed effects of the transition from liquid nitrogen to dry ice on cell viability;apoptosis;phenotype;proliferation;immunomodulation;and clonogenesis;and validated dry ice-based transport of UC-MSCs to clinics. Results: Our results showed no differences in cell functionality related to the two storage conditions, and demonstrated the preservation of immunomodulatory and clonogenic potentials in dry ice. UC-MSCs were successfully delivered to points-of-care, enabling favourable clinical outcomes. Conclusions: This experience underscores the flexibility of a public cell factory in its adaptation of the logistics of an advanced therapy medicinal product during a public health crisis. Alternative supply chains should be evaluated for other cell products to guarantee delivery during catastrophes.

4.
Cancer Med ; 10(18): 6310-6316, 2021 09.
Article in English | MEDLINE | ID: covidwho-1378924

ABSTRACT

BACKGROUND: Patients with hematological malignancies are at an increased risk of SARS-CoV-2 disease (COVID-19) and adverse outcome. However, a low mortality rate has been reported in patients with chronic myeloid leukemia (CML). Preclinical evidence suggests that tyrosine kinase inhibitors (TKIs) may have a protective role against severe COVID-19. METHODS: We conducted a cross-sectional study of 564 consecutive patients with CML who were tested for anti-SARS-CoV-2 IgG/IgM antibodies at their first outpatient visit between May and early November 2020 in five hematologic centers representative of three Italian regions. RESULTS: The estimated serological prevalence of SARS-CoV-2 infection in patients with CML after the first pandemic wave was similar to that in the general population (about 2%), both at national and regional levels. CML patients with positive anti-SARS-CoV-2 serology were more frequently male (p = 0.027) and active workers (p = 0.012), while there was no significant association with TKI treatment type. Only 3 out of 11 IgG-positive patients had previously received a molecular diagnosis of COVID-19, while the remainders were asymptomatic or with mild symptoms. CONCLUSIONS: Our data confirm that the course of SARS-CoV-2 infection in patients with CML is generally mild and reassure about the safety of continuing TKIs during the COVID-19 pandemic. Furthermore, we suggest that patients with CML succeed to mount an antibody response after exposure to SARS-CoV-2, similar to the general population.


Subject(s)
COVID-19/immunology , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/virology , SARS-CoV-2/immunology , Adult , Aged , Aged, 80 and over , COVID-19 Serological Testing/methods , Cross-Sectional Studies , Female , Humans , Immunoglobulin G/immunology , Immunoglobulin M/immunology , Italy , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/immunology , Male , Middle Aged , Prevalence , Young Adult
5.
Blood ; 136(Supplement 1):42-42, 2020.
Article in English | PMC | ID: covidwho-1339017

ABSTRACT

Background. Clinical course of the novel Coronavirus (SARS-CoV-2) Disease 2019 (COVID-19) is extremely heterogeneous, and infected individuals may be asymptomatic or develop acute respiratory manifestations. Elderly people and patients with pre-existing comorbidities, including malignancies, may be at higher risk due to their immunological impairment. On the other hand, still limited evidence suggests that some target drugs used to treat hematological cancers, including tyrosine kinase inhibitors (TKI), may have a direct antiviral action or an indirect immunomodulatory effect on the abnormal inflammatory host response to SARS-CoV-2.Aims. To describe the prevalence of symptomatic and asymptomatic SARS-CoV-2 infection in a cohort of chronic myeloid leukemia (CML) patients.Methods.This is an ongoing prospective study ideated and conducted in the Centers of the regional network Rete Ematologica Veneta (REV). According to the Italian Ministry of Health data as of Jul 22, 2020, prevalence of SARS-CoV-2 infection in Veneto, as documented by molecular test on pharyngeal swab, was 0.4%. For comparison, two other centers from Regions with lower prevalence (Lazio and Friuli-Venezia Giulia) were included. All consecutive CML patients coming to the participating Centers were offered to participate to the study, which was approved by local IRBs. Patients in Treatment Free Remission (TFR) phase (i.e. not taking TKI at the time of pandemic) were included as a control group. After collecting information about risk factors for COVID-19 (travels, work exposure, cohabitation with infected subjects) and respiratory or general symptoms experienced from mid Feb 2020, patients were tested for anti-SARS-CoV-2 IgM and/or IgG antibodies through a immunochromatographic qualitative assay (COVID-19 IgG/IgM Rapid Test Cassette, Menarini Diagnostics, IT;sensitivity IgG 97.2%, IgM 87.9%, specificity IgG/IgM 100%). Patients with positive results underwent a pharyngeal swab for molecular detection of the virus.Results. From May 18 to Jul 29, 2020 a total of 339 patients were enrolled (238 from REV centers and 101 from other centers). Males were 183 (54%), median age was 63.2 (range 26.5-93) years. Median time from CML diagnosis was 8 (range 0.1-29.6) years. The majority of patients were in frontline TKI treatment (n=174, 51.3%), and the remaining were in 2ndline (n=80, 23.6%), 3rdor further line of treatment (n=35, 10.3%), or in TFR (n=50, 14.7%). The type of TKI currently assumed was imatinib (n=134, 39.5%), nilotinib (n=63, 18.6%), dasatinib (n=52, 15.4%), bosutinib (n= 24, 7.1%), ponatinib (n=14, 4.1%) or experimental (n=2, 0.6%). The majority of patients was in major (n=79, 23.3%) or deep molecular response (n=204, 60.2%).Thirteen and 3 patients declared close contact with COVID-19 infected individuals at work and/or at home, respectively. The frequency of newly onset or worsening symptoms during the last months was as follows: anosmia (2.4%), ageusia (2.1%), cough (4.7%), pharyngitis (2.6%), dyspnea (2.4%), fever (3.2%), headache (7.7%), asthenia (13.6%), arthralgia (14.9%), dizziness (6.5%), nausea/vomiting (2.7%), and diarrhea (4.4%).Five patients out of the 238 in the REV cohort (2.1%) had a positive IgG test, and two of them were also IgM-positive. All resulted negative at swab performed after the serological assay. They were 4 males and 1 female, aged between 53 and 72 years. One of them, in treatment with nilotinib, had a symptomatic infection in early March, confirmed at that time by molecular tests, and reported close contact with infected subjects both at work and at home. All the other patients (2 in treatment with imatinib, 1 with nilotinib and 1 with bosutinib) reported no or only mild symptoms and had not performed diagnostic tests for SARS-CoV-2 before. Anosmia, ageusia and fever were the only symptoms significantly associated with anti-SARS-CoV-2 IgG positive test (p<0.001). All the patients from the other two Regions and all the patients in TFR had a negative IgG/IgM test.Conclusions. We reported for the first time the serol gical prevalence of SARS-CoV-2 infection in CML patients. Serological studies in the general Italian population are ongoing and will be used to make comparisons with our cohort. Prospective enrollment in the present study is ongoing and updated results will be presented at the Meeting.Acknowledgment. This work was supported by Fondazione Cariverona (ENACT Project).

6.
Blood Cancer J ; 11(6): 115, 2021 06 16.
Article in English | MEDLINE | ID: covidwho-1275905
7.
Stem Cell Res Ther ; 12(1): 316, 2021 06 02.
Article in English | MEDLINE | ID: covidwho-1255964

ABSTRACT

Coronavirus disease 2019 (COVID-19) may result in a life-threatening condition due to a hyperactive immune reaction to severe acute respiratory syndrome-coronavirus-2 infection, for which no effective treatment is available. Based on the potent immunomodulatory properties of mesenchymal stromal cells (MSCs), a growing number of trials are ongoing. This prompted us to carry out a thorough immunological study in a patient treated with umbilical cord-derived MSCs and admitted to the Intensive Care Unit for COVID-19-related pneumonia. The exploratory analyses were assessed on both peripheral blood and bronchoalveolar fluid lavage samples at baseline and after cellular infusion by means of single-cell RNA sequencing, flow cytometry, ELISA, and functional assays. Remarkably, a normalization of circulating T lymphocytes count paralleled by a reduction of inflammatory myeloid cells, and a decrease in serum levels of pro-inflammatory cytokines, mostly of interleukin-6 and tumor necrosis factor-α, were observed. In addition, a drop of plasma levels of those chemokines essential for neutrophil recruitment became evident that paralleled the decrease of lung-infiltrating inflammatory neutrophils. Finally, circulating monocytes and low-density gradient neutrophils acquired immunosuppressive function. This scenario was accompanied by an amelioration of respiratory, renal, inflammatory, and pro-thrombotic indexes. Our results provide the first immunological data possibly related to the use of umbilical cord-derived MSCs in severe COVID-19 context.


Subject(s)
COVID-19 , Mesenchymal Stem Cell Transplantation , Mesenchymal Stem Cells , Humans , SARS-CoV-2 , Umbilical Cord
10.
Leukemia ; 35(2): 485-493, 2021 02.
Article in English | MEDLINE | ID: covidwho-1065836

ABSTRACT

We report the clinical presentation and risk factors for survival in 175 patients with myeloproliferative neoplasms (MPN) and COVID-19, diagnosed between February and June 2020. After a median follow-up of 50 days, mortality was higher than in the general population and reached 48% in myelofibrosis (MF). Univariate analysis, showed a significant relationship between death and age, male gender, decreased lymphocyte counts, need for respiratory support, comorbidities and diagnosis of MF, while no association with essential thrombocythemia (ET), polycythemia vera (PV), and prefibrotic-PMF (pre-PMF) was found. Regarding MPN-directed therapy ongoing at the time of COVID-19 diagnosis, Ruxolitinib (Ruxo) was significantly more frequent in patients who died in comparison with survivors (p = 0.006). Conversely, multivariable analysis found no effect of Ruxo alone on mortality, but highlighted an increased risk of death in the 11 out of 45 patients who discontinued treatment. These findings were also confirmed in a propensity score matching analysis. In conclusion, we found a high risk of mortality during COVID-19 infection among MPN patients, especially in MF patients and/or discontinuing Ruxo at COVID-19 diagnosis. These findings call for deeper investigation on the role of Ruxo treatment and its interruption, in affecting mortality in MPN patients with COVID-19.


Subject(s)
COVID-19/mortality , Myeloproliferative Disorders/mortality , Pyrazoles/administration & dosage , SARS-CoV-2/isolation & purification , Withholding Treatment/statistics & numerical data , Aged , COVID-19/complications , COVID-19/transmission , COVID-19/virology , Europe/epidemiology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myeloproliferative Disorders/drug therapy , Myeloproliferative Disorders/epidemiology , Myeloproliferative Disorders/virology , Nitriles , Prognosis , Pyrimidines , Retrospective Studies , Survival Rate
11.
J Transl Med ; 18(1): 451, 2020 11 30.
Article in English | MEDLINE | ID: covidwho-949113

ABSTRACT

BACKGROUND: During the coronavirus disease-2019 (COVID-19) pandemic, Italian hospitals faced the most daunting challenges of their recent history, and only essential therapeutic interventions were feasible. From March to April 2020, the Laboratory of Advanced Cellular Therapies (Vicenza, Italy) received requests to treat a patient with severe COVID-19 and a patient with acute graft-versus-host disease with umbilical cord-derived mesenchymal stromal cells (UC-MSCs). Access to clinics was restricted due to the risk of contagion. Transport of UC-MSCs in liquid nitrogen was unmanageable, leaving shipment in dry ice as the only option. METHODS: We assessed effects of the transition from liquid nitrogen to dry ice on cell viability; apoptosis; phenotype; proliferation; immunomodulation; and clonogenesis; and validated dry ice-based transport of UC-MSCs to clinics. RESULTS: Our results showed no differences in cell functionality related to the two storage conditions, and demonstrated the preservation of immunomodulatory and clonogenic potentials in dry ice. UC-MSCs were successfully delivered to points-of-care, enabling favourable clinical outcomes. CONCLUSIONS: This experience underscores the flexibility of a public cell factory in its adaptation of the logistics of an advanced therapy medicinal product during a public health crisis. Alternative supply chains should be evaluated for other cell products to guarantee delivery during catastrophes.


Subject(s)
COVID-19/therapy , Delivery of Health Care/organization & administration , Dry Ice , Mesenchymal Stem Cell Transplantation , Mesenchymal Stem Cells/cytology , Point-of-Care Systems/organization & administration , Transportation , Acute Disease , COVID-19/epidemiology , COVID-19/pathology , Cell Proliferation , Cell Survival , Cells, Cultured , Cord Blood Stem Cell Transplantation/adverse effects , Delivery of Health Care/standards , Equipment and Supplies, Hospital/standards , Equipment and Supplies, Hospital/supply & distribution , Graft vs Host Disease/etiology , Graft vs Host Disease/pathology , Graft vs Host Disease/therapy , Humans , Italy/epidemiology , Materials Management, Hospital/organization & administration , Materials Management, Hospital/standards , Mesenchymal Stem Cell Transplantation/methods , Mesenchymal Stem Cell Transplantation/standards , Mesenchymal Stem Cells/physiology , Organization and Administration/standards , Pandemics , Phenotype , Point-of-Care Systems/standards , SARS-CoV-2/physiology , Severity of Illness Index , Transportation/methods , Transportation/standards
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