Impact of Bamlanivimab Monoclonal Antibody Treatment on Hospitalization and Mortality Among Nonhospitalized Adults With Severe Acute Respiratory Syndrome Coronavirus 2 Infection
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Abstract
Background
Monoclonal antibody treatment may prevent complications of coronavirus disease 2019 (COVID-19). We sought to quantify the impact of bamlanivimab monoclonal antibody monotherapy on hospitalization and mortality among outpatients at high risk of COVID-19 complications.
Methods
In this observational study we compared outpatients who received bamlanivimab monoclonal antibody from December 9, 2020 to March 3, 2021 to nontreated patients with a positive polymerase chain reaction or antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the same period who were eligible for monoclonal antibody treatment. The primary outcome was 28-day hospitalization or all-cause mortality, and the secondary outcome was hospitalization or emergency department visit without hospitalization. The risk-adjusted odds of study outcomes comparing bamlanivimab treated and untreated patients was determined using 1:5 propensity matching and multivariable logistic regression.
Results
Among 232 patients receiving bamlanivimab matched with 1160 comparator patients, the mean age was 67 years, 56% were female, and 196 (14%) of patients experienced hospitalization or mortality. After adjustment for propensity to receive treatment, bamlanivimab treatment was associated with a significantly reduced risk-adjusted odds of hospitalization or mortality within 28 days (odds ratio [OR], 0.40; 95% confidence interval [95% CI], 0.24–0.69; P < .001). Bamlanivimab treatment was also associated with a significantly lower risk adjusted odds of hospitalization or emergency department visit without hospitalization (OR, 0.54; 95% CI, 0.35–0.82; P = .004). The results were most strongly associated with patients age 65 years and older.
Conclusions
Bamlanivimab monoclonal antibody monotherapy was associated with reduced hospitalizations and mortality within 28 days among outpatients with mild to moderate COVID-19.
Use of bamlanivimab monotherapy for outpatients with mild to moderate COVID-19 infection was associated with reductions in hospitalizations and mortality within 28 days. Benefit was strongest in those age 65 years or older
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SciScore for 10.1101/2021.03.25.21254322: (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 UPMC Quality Improvement Review Committee (Project ID 2882 and Project ID 3116). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Methods and results are reported in accordance with The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement (see Supplemental Table 3).16 RECORDsuggested: (RECORD, RRID:SCR_009097)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 N…
SciScore for 10.1101/2021.03.25.21254322: (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 UPMC Quality Improvement Review Committee (Project ID 2882 and Project ID 3116). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Methods and results are reported in accordance with The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement (see Supplemental Table 3).16 RECORDsuggested: (RECORD, RRID:SCR_009097)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:There are several limitations of our study. Given our design, it is not surprising that there were several baseline differences between those infused and not infused in other age groups. We mitigated confounding with propensity score modeling of closely matched groups of patients, and a sensitivity analysis using propensity-score adjusted unmatched patients not receiving mAb infusion affirmed the findings. Furthermore, the group receiving mAb had more comorbid conditions predisposing to the primary and secondary outcomes, which may underestimate the magnitude of the treatment effect if there was residual confounding. We cannot reliably distinguish the presence, extent, or severity of symptoms in our data set, all of which may impact effectiveness. Additionally, viral loads in blood or any site were not measured in our data set, limiting any insights based on this variable. The time to event in both treated and untreated groups were similar, suggesting that ED visit or hospitalization did not account for why the untreated population did not receive mAb. Viral loads in blood or any site were not measured in our data set, limiting any insights based on this variable. We did not have information regarding variant strains of SARS-CoV-2 prior to or after bamlanivimab monotherapy. While reported rates of clinically concerning variants were low in Pennsylvania during much of this time frame, there is concern that use of bamlanivimab monotherapy will lead to escape variants and/or tha...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
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.
- Thank you for including a protocol registration statement.
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