Clinical trial NCT04760184: Impact of COVID-19 After Autologous Hematopoietic Stem Cell Transplantation in Sweden
Official title: Impact of COVID-19 on Patients Treated With Autologous Hematopoietic Stem Cell Transplantation in Sweden - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Myeloma Multiple
Malignant Lymphoma
Hematologic Neoplasms
Stem Cell Transplant Complications
Keywords: Autologous stem cell transplantation
COVID-19
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Sahlgrenska University Hospital
name: Lund University Hospital
name: University Hospital, Linkoeping
name: University Hospital, Umeå
name: Region Örebro County
name: Uppsala University Hospital
First posted: 2021-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of hematological cancer (C81-C96 according to the International Classification of Diseases 10th revision (ICD-10).
* Autologous hematopoietic stem cell transplantation performed 1 January 2020 until 31st December 2020 at a Swedish transplantation center.
* Positive RT-PCR test for SARS-CoV-2 performed in Sweden

Exclusion Criteria:

- Age below 18 years and 0 months at the time of transplantation

Primary outcomes:
measure: Overall survival
timeFrame: 30 days
measure: Overall survival
timeFrame: 90 days
measure: COVID-19 related mortality
timeFrame: within 6 months after infection
Secondary outcomes:
measure: Time of COVID-19 infection
timeFrame: Up to 15 months
measure: Hospitalization
timeFrame: Up to 15 months
measure: Oxygen treatment
timeFrame: Up to 15 months
measure: High-flow oxygen therapy
timeFrame: Up to 15 months
measure: Non-invasive ventilation
timeFrame: Up to 15 months
measure: Intensive care
timeFrame: Up to 15 months
measure: Invasive mechanical ventilation
timeFrame: Up to 15 months
measure: ECMO
timeFrame: Up to 15 months
measure: Occurence of ARDS
timeFrame: Up to 15 months
measure: Occurence of arterial thrombosis
timeFrame: Up to 15 months
measure: Occurence of venous thrombosis
timeFrame: Up to 15 months
measure: Occurence of arrhythmias
timeFrame: Up to 15 months
measure: Occurence of acute cardiac injury
timeFrame: Up to 15 months
measure: Occurence of secondary infection
timeFrame: Up to 15 months
measure: Occurence of cytokine release syndrome
timeFrame: Up to 15 months
measure: Comorbidities
timeFrame: Prior to autologous stem cell transplantation
measure: Disease status
timeFrame: Prior to autologous stem cell transplantation
measure: Previous disease modifying treatment
timeFrame: Prior to autologous stem cell transplantation
measure: Conditioning treatment
timeFrame: At autologous stem cell transplantation
measure: Time of infection
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Neutropenia
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Elevated CRP
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Elevated leukocyte count
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Lymphocytopenia
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Elevated liver enzymes
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Elevated lactate dehydrogenase
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Elevated ferritin
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Elevated d-dimer
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Prolonged aPTT
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Elevated troponin
timeFrame: At autologous stem cell transplantation or up to 15 months
measure: Elevated creatinine
timeFrame: At autologous stem cell transplantation or up to 15 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala Universitet
Study officials:
affiliation: Department of Medical Sciences, Uppsala University
name: Honar Cherif, MD, Ass prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Clinical Research Dalarna and Department of Medical Sciences-Uppsala University
name: Thomas Silfverberg, MD
role: STUDY_CHAIR
affiliation: Department of Medical Sciences, Uppsala University
name: Kristina Carlson, MD, Ass Prof
role: STUDY_CHAIR
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