Hospitalized COVID-19 patients treated with convalescent plasma in a mid-size city in the Midwest
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Abstract
Background
SARS-CoV-2 and its associated disease, COVID-19, has infected over seven million people world-wide, including two million people in the United States. While many people recover from the virus uneventfully, a subset of patients will require hospital admission, some with intensive care needs including intubation, and mechanical ventilation. To date there is no cure and no vaccine is available. Passive immunotherapy by the transfusion of convalescent plasma donated by COVID-19 recovered patients might be an effective option to combat the virus, especially if used early in the course of disease. Here we report our experience of using convalescent plasma at a tertiary care center in a mid-size, midwestern city that did not experience an overwhelming patient surge.
Methods
Hospitalized COVID-19 patients categorized as having Severe or Life-Threatening disease according to the Mayo Clinic Emergency Access Protocol were screened, consented, and treated with convalescent plasma collected from local donors recovered from COVID-19 infection. Clinical data and outcomes were collected retrospectively.
Results
31 patients were treated, 16 severe patients and 15 life-threatened patients. Overall mortality was 27% (4/31) but only patients with life-threatening disease died. 94% of transfused patients with severe disease avoided escalation to ICU care and mechanical ventilation. 67% of patients with life-threatening disease were able to be extubated. Most transfused patients had a rapid decrease in their respiratory support requirements on or about day 7 following convalescent plasma transfusion.
Conclusion
Our results demonstrate that convalescent plasma is associated with reducing ventilatory requirements in patients with both severe and life-threatening disease, but appears to be most beneficial when administered early in the course of disease when patients meet the criteria for severe illness.
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SciScore for 10.1101/2020.06.19.20135830: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This study was approved by the University of Wisconsin Institutional Review Board.
Consent: Cases met all criteria for enrollment under the Mayo Clinic Expanded Access Protocol (IND # 20-003312) and gave written, informed consent for CP transfusion and data collection.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
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 …SciScore for 10.1101/2020.06.19.20135830: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This study was approved by the University of Wisconsin Institutional Review Board.
Consent: Cases met all criteria for enrollment under the Mayo Clinic Expanded Access Protocol (IND # 20-003312) and gave written, informed consent for CP transfusion and data collection.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
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:(12) Our report has significant limitations. Because our institution did not see a large COVID-19 patient surge like those experienced elsewhere, we were unable to develop a well-matched control group for the purposes of comparison. Our patient population is also relatively homogenous and with good access to medical care. In addition, because most of our CP came from donors in the earliest phases of collection, we did not have donor antibody titers available for analysis. In summary, our experience to date at a large Midwest academic medical center demonstrates evidence of clinical benefit for patients treated with COVID-19 convalescent plasma in both the severe and life-threatening patient populations. Although our data supports the promise of this therapy it also underscores the importance of ongoing and additional planned randomized clinical trials of CCP in the full spectrum of COVID-19 clinical presentations from salvage therapy in critically ill, mechanically ventilated patients to post-exposure prophylaxis/prevention in high risk individuals. (17)
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.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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