Clinical Characteristics and Outcomes of Immunocompromised Patients With Coronavirus Disease 2019 Caused by the Omicron Variant: A Prospective, Observational Study
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Abstract
Background
Illness after infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant is less severe compared with previous variants. Data on the disease burden in immunocompromised patients are lacking. We investigated the clinical characteristics and outcomes of immunocompromised patients with coronavirus disease 2019 (COVID-19) caused by Omicron.
Methods
Organ transplant recipients, patients on anti-CD20 therapy, and allogenic hematopoietic stem cell transplantation recipients infected with the Omicron variant were included. Characteristics of consenting patients were collected and patients were contacted regularly until symptom resolution. To identify possible risk factors for hospitalization, a univariate logistic analysis was performed.
Results
114 consecutive immunocompromised patients were enrolled. Eighty-nine percent had previously received 3 mRNA vaccinations. While only 1 patient died, 23 (20%) were hospitalized for a median of 11 days. A low SARS-CoV-2 immunoglobulin G (IgG) antibody response (<300 BAU [binding antibody units]/mL) at diagnosis, being older, being a lung transplant recipient, having more comorbidities, and having a higher frailty score were associated with hospital admission (all P < .01). At the end of follow-up, 25% had still not fully recovered. Of the 23 hospitalized patients, 70% had a negative and 92% had a low IgG (<300 BAU/mL) antibody response at admission. Sotrovimab was administered to 17 of these patients, and 1 died.
Conclusions
While the mortality in immunocompromised patients infected with Omicron was low, hospital admission was frequent and the duration of symptoms often prolonged. In addition to vaccination, other interventions are needed to limit the morbidity from COVID-19 in immunocompromised patients.
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SciScore for 10.1101/2022.04.25.22273197: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical Approvals: The institutional review board at Erasmus MC University Medical Center in Rotterdam (officially called “Medisch Ethische Toetsingscommissie Erasmus MC, METC Erasmus MC”) reviewed the protocol.
Consent: However, all SOTR provided written informed consent for the use of their clinical data as part of an ongoing quality improvement program and the non-SOTR group consented for use of their data in the context of this study.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical Analysis: Analyses were performed in SPSS (version 28) and … SciScore for 10.1101/2022.04.25.22273197: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical Approvals: The institutional review board at Erasmus MC University Medical Center in Rotterdam (officially called “Medisch Ethische Toetsingscommissie Erasmus MC, METC Erasmus MC”) reviewed the protocol.
Consent: However, all SOTR provided written informed consent for the use of their clinical data as part of an ongoing quality improvement program and the non-SOTR group consented for use of their data in the context of this study.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical Analysis: Analyses were performed in SPSS (version 28) and GraphPad Prism 9. SPSSsuggested: (SPSS, RRID:SCR_002865)GraphPadsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study has several limitations. Firstly, it is possible that the observed morbidity is overestimated since we cannot exclude that mild COVID-19 cases remained undiagnosed. However, test locations are easily accessible across the Netherlands, self-tests are available at very low costs, and the importance of testing in these vulnerable patients is constantly emphasized by their health care workers. In addition, our cohort is relatively small, with the majority being a SOTR, and therefore it represents a rather small part of the diverse immunocompromised patient population. Studies on the burden of infection with Omicron in other prevalent patient groups, including those treated for a chronic lymphocytic leukemia, multiple myeloma or other T or B-cell diseases, are therefore needed. Finally, a part of the hospital admissions could have been prevented by the use of sotrovimab in the outpatient setting. Unfortunately, with BA.2 now being the dominant variant in the Netherlands, sotrovimab is unlikely to be of benefit as its in vitro activity to this variant is limited [9,11]. In conclusion, in a highly vaccinated population of immunocompromised patients, we observed a very low mortality from COVID-19 caused by Omicron. The morbidity however, continues to be very substantial despite Omicron BA.1 being the dominant variant. In particular lung– and kidney transplant recipients are likely to benefit from early treatment for COVID-19. However, the recently reported reduced or comple...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- No funding statement was detected.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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