This retrospective observational cohort study aims to describe the impact of COVID-19 in patients treated with autologous stem cell transplantation (ASCT) for malignant disease in terms of risk factors, morbidity, need for supportive care and mortality. All patients treated with ASCT in Sweden from 1st January 2020 until 31st December 2020 are eligible for this study. Patients who also has tested positive for SARS-CoV-2 from start of conditioning or later will be identified through the national registry of the Public Health Agency of Sweden and a systematic analysis of their medical records will be performed.
Research question How does infection with SARS-CoV-2 affect patients with hematological malignancies who are treated with autologous hematopoietic stem cell transplantation? Study population All Swedish citizens treated with ASCT for malignant disease in Sweden from 1st January 2020 until 31st December 2020 are eligible for this study. There will be a minimum follow-up time of one month for all patients. Data collection and storage Patients will be identified using local ASCT registers at the seven university hospitals, as there is no national register for ASCT-patients in Sweden. These seven university hospitals are the only sights to perform ASCT in Sweden. The Public Health Agency of Sweden (Folkhälsomyndigheten - FHM) has the national responsibility to surveil and control communicable disease. The FHM uses several different surveillance systems to monitor the spread of COVID-19. Since COVID-19 is subject to mandatory reporting under the Communicable Diseases Act, physicians and laboratories continuously supply data to be analyzed daily by the FHM. The coverage of this database is estimated to be very high, close to 100%. For this study the investigators will link the patients identified through the ASCT-centers with the register of SARS-Cov-2 positive patients (SmiNet) held by the FHM. Patients who has tested positive for SARS-CoV-2 on the day of start of conditioning or at any given time thereafter will be included in the study. Inclusion of positive SARS-CoV-2 tests will start from 1st January 2020 until 31st March 2021 to allow for 3 months of follow-up after transplantation. For every ASCT-patient that has tested positive for COVID-19 after ASCT a systematic analysis of their medical records will be performed to describe the circumstances, impact and outcome of the COVID-19. All data collected will be stored in a deidentified data set on a secure server held by Dalarna Country Council where name and social security number have been erased and given a coded study number. Each patient will only be identified using a separately stored code key. All storage, correspondence and analysis with the code key and pseudonymized data set will adhere to current European General Data Protection Regulation (GDPR) guidelines. The code key will be destroyed as soon as data collection is completed, data quality is secured and the final report is published. The data set will be stored for 10 years and then be destroyed.
Study Type
OBSERVATIONAL
Enrollment
20
The study will describe the implications of COVID-19 infection following autologous stem cell transplantation
Uppsala Universitet
Uppsala, Sweden
Overall survival
Overall survival after infection with COVID-19
Time frame: 30 days
Overall survival
Overall survival after infection with COVID-19
Time frame: 90 days
COVID-19 related mortality
As classified by the WHO; a death resulting from a clinically compatible illness in a confirmed COVID-19 case, unless there is a clear alternative cause of death that cannot be related to COVID disease (e.g., trauma). There should be no period of complete recovery between the illness and death
Time frame: within 6 months after infection
Time of COVID-19 infection
Time of SARS-CoV-2 infection in relation to autologous stem cell transplantation
Time frame: Up to 15 months
Hospitalization
Duration of hospitalization
Time frame: Up to 15 months
Oxygen treatment
Duration of oxygen treatment
Time frame: Up to 15 months
High-flow oxygen therapy
Duration of high-flow oxygen therapy
Time frame: Up to 15 months
Non-invasive ventilation
Duration of non-invasive ventilation (NIV)
Time frame: Up to 15 months
Intensive care
Duration of care in intensive care unit
Time frame: Up to 15 months
Invasive mechanical ventilation
Duration of Invasive mechanical ventilation
Time frame: Up to 15 months
ECMO
Duration of extracorporeal membrane oxygenation (ECMO)
Time frame: Up to 15 months
Occurence of ARDS
Diagnosis of Acute respiratory distress syndrome (ARDS)
Time frame: Up to 15 months
Occurence of arterial thrombosis
Event of arterial thrombosis
Time frame: Up to 15 months
Occurence of venous thrombosis
Event of venous thrombosis
Time frame: Up to 15 months
Occurence of arrhythmias
Event of recorded arrhythmias
Time frame: Up to 15 months
Occurence of acute cardiac injury
Event of acute cardiac injury
Time frame: Up to 15 months
Occurence of secondary infection
Event of any secondary infection
Time frame: Up to 15 months
Occurence of cytokine release syndrome
Event of cytokine release syndrome
Time frame: Up to 15 months
Comorbidities
Description of comorbidities prior to autologous stem cell transplantation
Time frame: Prior to autologous stem cell transplantation
Disease status
Description of disease status prior to autologous stem cell transplantation
Time frame: Prior to autologous stem cell transplantation
Previous disease modifying treatment
Description of previous disease modifying treatment prior to autologous stem cell transplantation
Time frame: Prior to autologous stem cell transplantation
Conditioning treatment
Description of conditioning treatment prior to autologous stem cell transplantation
Time frame: At autologous stem cell transplantation
Time of infection
Time of COVID-19 in relation to autologous stem cell transplantation
Time frame: At autologous stem cell transplantation or up to 15 months
Neutropenia
Event of neutropenia at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated CRP
Event of elevated C-reactive protein (CRP) at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated leukocyte count
Event of elevated leukocyte count at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Lymphocytopenia
Event of lymphocytopenia at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated liver enzymes
Event of elevated liver enzymes at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated lactate dehydrogenase
Event of elevated lactate dehydrogenase at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated ferritin
Event of elevated ferritin at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated d-dimer
Event of elevated d-dimer at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Prolonged aPTT
Event of prolonged activated partial thromboplastin time (aPTT) at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated troponin
Event of elevated troponin at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated creatinine
Event of elevated creatinine at diagnosis of COVID-19
Time frame: At autologous stem cell transplantation or up to 15 months
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