Neutralizing Monoclonal Antibody Treatment Reduces Hospitalization for Mild and Moderate Coronavirus Disease 2019 (COVID-19): A Real-World Experience

Abstract

Background Neutralizing monoclonal antibody (NmAb) treatments have received emergency use authorization to treat patients with mild or moderate COVID-19 infection. To date, no real- world data about the efficacy of NmAb has been reported from clinical practice. We assessed the impact of NmAb treatment given in the outpatient clinical practice setting on hospital utilization. Methods Electronic medical records were used to identify adult COVID-19 patients who received NmAbs [bamlanivimab (BAM) or casirivimab and imdevimab (REGN-COV2)] and historic COVID-19 controls. Post-index hospitalization rates were compared. Results 707 confirmed COVID-19 patients received NmAb and 1709 historic COVID-19 controls were included; 553 (78%) received BAM, 154 (22%) received REGN-COV2. Patients receiving NmAb infusion had significantly lower hospitalization rate (5.8% vs. 11.4%, p<0.0001); a shorter length of stay if hospitalized (mean 5.2 days vs. 7.4 days, p=0.02), and fewer ED visits within 30 days post-index (8.1% vs 12.3%, p=0.003) than controls. Hospitalization-free survival was significantly longer in NmAb patients compared to controls (p<0.0001). There was a trend towards a lower hospitalization rate among patients who received NmAb within 2-4 days after symptom onset. In multivariate analysis, having received a NmAb transfusion was independently associated with a lower risk of hospitalization after adjustment for age, sex, race, BMI and referral source: adjusted hazard ratio (95% CI) = 0.54 (0.38 – 0.79), p=0.0012. Overall mortality was not different between the two groups. Conclusions and Relevance NmAb treatment reduced hospital utilization especially when received within a few days of symptom onset. Further study is needed to validate these findings.

Effectiveness of Regdanvimab Treatment in High-Risk COVID-19 Patients to Prevent Progression to Severe Disease

“…These findings consistently indicate that regdanvimab treatment offers clinical benefit for high-risk patients. Because most mild to moderate COVID-19 patients of the Republic of Korea are managed at designated general hospitals, these primary outcomes of the present study are not identical with those of clinical trials conducted for non-hospitalized COVID-19 patients (4,7,9). The clinical status of COVID-19 patients who require O 2 supplementation in the present study would be similar or slightly more severe than those who require hospitalization in those trials, though indications for hospitalization were not clearly presented (4,7,9).…”

“…Because most mild to moderate COVID-19 patients of the Republic of Korea are managed at designated general hospitals, these primary outcomes of the present study are not identical with those of clinical trials conducted for non-hospitalized COVID-19 patients (4,7,9). The clinical status of COVID-19 patients who require O 2 supplementation in the present study would be similar or slightly more severe than those who require hospitalization in those trials, though indications for hospitalization were not clearly presented (4,7,9). Since those clinical trials did not evaluated progression to severe disease as an outcome value, the finding of the present study would additionally support effectiveness of mAb agents for mild to moderate COVID-19 patients.…”

“…To date, regdanvimab has been widely administered in Korean COVID-19 designated hospitals, but the data from clinical trials of regdanvimab have not been published as a full scientific article yet ( 13 ). As evaluation of the clinical efficacy of treatment modalities in a real-world setting would be especially necessary for drugs under emergency use authorizations ( 4 ), we conducted the present retrospective cohort study for scientific background for COVID-19 management.…”

“…The coronavirus disease 2019 (COVID-19) pandemic is ongoing and has caused more than four million deaths as of October 2021 (1). Among the therapeutic agents tested against COVID-19, neutralizing monoclonal antibody (mAb) agents against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were found to decrease viral loads and prevent disease progression of mild COVID-19 (2)(3)(4)(5)(6)(7)(8)(9). On September 2021, US National Institutes of Health recommended use of anti-SARS-CoV-2 mAb regimens, including casirivimab/imdevimab (Regeneron Pharmaceuticals Inc., NY, USA), bamlanivimab/etesevimab (Eli L i l l y a n d C o m p a n y , I N , U S A ) , a n d s o t r o v i m a b (GlaxoSmithKline LLC, NC, USA), to treat non-hospitalized patients with mild to moderate COVID-19 who are at high risk of clinical progression (10).…”

Delayed SARS-CoV-2 Clearance in Patients with Obesity

“…2 Considering that angiotensin-converting enzyme 2 (ACE2) receptor in host cells and the receptorbinding domain in SARS-Cov-2 spike protein are essential for viral entry and replication, ACE2 inhibitor and neutralizing antibodies are potential antiviral drugs with promising effects. [3][4][5][6] Moreover, knowledge about the correlation between viral load and other indicators of infection is limited. Also, it lacks indicators predicting the early clearance of viral load during infection.…”