Bamlanivimab improves hospitalization and mortality rates in patients with COVID-19: A systematic review and meta-analysis

Zuo, Ling; Ao, Guangyu; Wang, Yushu; Gao, Ming; X, Qi

doi:10.1016/j.jinf.2021.09.003

Cited by 11 publications

(9 citation statements)

References 15 publications

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“…MSCs decreased both the relative and absolute risk of death at the study endpoint compared to controls in our meta-analysis and MSCs decreased the relative risk of death at 28 days. Although a limited number of other therapeutics including remdesivir 34 and bamlanivimab 35 have also demonstrated promise in terms of decreasing mortality in patients suffering from COVID-19, their mechanisms of action appear more limited in scope. Although the specific mechanisms and pathways interrogated by MSCs in patients with COVID-19 have yet to be confirmed, work in other related diseases and conditions indicates that MSCs ameliorate COVID-19 through a combination of immunomodulatory, antibacterial, tissue regenerative, and anti-apoptotic mechanisms.…”

Section: Discussionmentioning

confidence: 99%

Updated Living Systematic Review and Meta-analysis of Controlled Trials of Mesenchymal Stromal Cells to Treat COVID-19: A Framework for Accelerated Synthesis of Trial Evidence for Rapid Approval—FASTER Approval

Kirkham

Bailey

Monaghan

et al. 2022

Stem Cells Translational Medicine

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Background Mesenchymal stromal cells (MSCs) may reduce mortality in patients with COVID-19; however, early evidence is based on few studies with marked interstudy heterogeneity. The second iteration of our living systematic review and meta-analysis evaluates a framework needed for synthesizing evidence from high-quality studies to accelerate consideration for approval. Methods A systematic search of the literature was conducted on November 15, 2021, to identify all English-language, full-text, and controlled clinical studies examining MSCs to treat COVID-19 (PROSPERO: CRD42021225431). Findings Eleven studies were identified (403 patients with severe and/or critical COVID-19, including 207 given MSCs and 196 controls). All 11 studies reported mortality and were pooled through random-effects meta-analysis. MSCs decreased relative risk of death at study endpoint (RR: 0.50 [95% CI, 0.34-0.75]) and RR of death at 28 days after treatment (0.19 [95% CI], 0.05-0.78) compared to controls. MSCs also decreased length of hospital stay (mean difference (MD: −3.97 days [95% CI, −6.09 to −1.85], n = 5 studies) and increased oxygenation levels at study endpoint compared to controls (MD: 105.62 mmHg O2 [95% CI, 73.9-137.3,], n = 3 studies). Only 2 of 11 studies reported on all International Society for Cellular Therapy (ISCT) criteria for MSC characterization. Included randomized controlled trials were found to have some concerns (n = 2) to low (n = 4) risk of bias (RoB), while all non-randomized studies were found to have moderate (n = 5) RoB. Interpretation Our updated living systematic review concludes that MSCs can likely reduce mortality in patients with severe or critical COVID-19. A master protocol based on our Faster Approval framework appears necessary to facilitate the more accelerated accumulation of high-quality evidence that would reduce RoB, improve consistency in product characterization, and standardize outcome reporting.

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Section: Discussionmentioning

confidence: 99%

Updated Living Systematic Review and Meta-analysis of Controlled Trials of Mesenchymal Stromal Cells to Treat COVID-19: A Framework for Accelerated Synthesis of Trial Evidence for Rapid Approval—FASTER Approval

Kirkham

Bailey

Monaghan

et al. 2022

Stem Cells Translational Medicine

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“…We read with interest the report in this journal by Zuo et al regarding the effectiveness of bamlanivimab in patients with COVID-19 1 . On April 16, 2021, the emergency use authorization for bamlanivimab monotherapy was rescinded by the FDA due to the evolution of SARS-CoV-2 variants.…”

Section: Dear Editormentioning

confidence: 99%

The effect of canakinumab on clinical outcomes in patients with COVID-19: A meta-analysis

Ao¹,

Wang

et al. 2022

Journal of Infection

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Section: Introductionmentioning

confidence: 99%

“…Overall mortality and risk of hospitalization were statistically significantly lower in the BAM treatment arms: OR = 0.27, 95% CI = 0.15-0.49, P < 0.0001, I 2 = 0% and OR = 0.60, 95% CI = 0.49-0.73, P < 0.00001, I 2 = 31%, respectively. 10 To evaluate the effectiveness of mAb infusions during the winter peak of COVID-19 in 2020-2021, we conducted a retrospective cohort study to compare the rates of hospitalization, emergency department (ED) visits, and deaths in high-risk patients who received either BAM or CAS/ IMD.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Monoclonal Antibodies in Preventing Hospitalizations, Emergency Department Visits, and Mortality in High-Risk COVID-19 Patients

Milam

Doan

Childress

et al. 2022

Journal of Pharmacy Technology

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Background The coronavirus disease 2019 (COVID-19) is a novel coronavirus that has caused an unprecedented global pandemic, with few treatment options currently available. Neutralizing monoclonal antibodies (mAbs) are a promising treatment approach to reduce hospitalizations in high-risk patients with mild-to-moderate COVID-19 infections. Objective The primary objective is to compare hospitalization rates of high-risk patients who tested positive for COVID-19 within 28 days between those who received mAb infusions versus those who did not. Secondary objectives were emergency department (ED) visits and mortality within 28 days of a positive test. Methods This single-center, institutional review board–approved, retrospective, observational cohort study included patients aged 19 years and older who tested positive for COVID-19 between December 2, 2020 and February 28, 2021. Patients who received the mAbs bamlanivimab or casirivimab/imdevimab were compared with patients who did not receive mAb infusions to examine hospitalization rates, ED visits, and mortality within 28 days of the positive COVID-19 test. Results A total of 2780 patients were evaluated for inclusion using electronic chart review via Cerner. Of the 1612 patients who met inclusion criteria, 568 received an mAb infusion (mAb group) and 1044 did not (non-mAb group). Baseline characteristics were similar between the 2 groups. Of the patients in the mAb group, 34 (6%) were hospitalized versus 397 (38%) in the non-mAb group. Patients with ED visits included 111 (20%) and 672 (64%) in the mAb and non-mAb groups, respectively. Finally, 5 patients in the mAb group experienced mortality (0.9%) versus 83 (8%) in the non-mAb group. Each endpoint achieved statistical significance with a P value of <0.0001. Conclusion Monoclonal antibody infusions are effective in preventing hospitalization, ED visits, and mortality in high-risk patients with mild-to-moderate COVID-19.

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Bamlanivimab improves hospitalization and mortality rates in patients with COVID-19: A systematic review and meta-analysis

Cited by 11 publications

References 15 publications

Updated Living Systematic Review and Meta-analysis of Controlled Trials of Mesenchymal Stromal Cells to Treat COVID-19: A Framework for Accelerated Synthesis of Trial Evidence for Rapid Approval—FASTER Approval

Updated Living Systematic Review and Meta-analysis of Controlled Trials of Mesenchymal Stromal Cells to Treat COVID-19: A Framework for Accelerated Synthesis of Trial Evidence for Rapid Approval—FASTER Approval

The effect of canakinumab on clinical outcomes in patients with COVID-19: A meta-analysis

Evaluation of Monoclonal Antibodies in Preventing Hospitalizations, Emergency Department Visits, and Mortality in High-Risk COVID-19 Patients

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