Real-world Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients With Early COVID-19

Abstract

Background Neutralizing monoclonal antibodies (MAb) are a promising therapy for early COVID-19, but effectiveness has not been confirmed in a real-world setting. Methods In this quasi-experimental pre-/post-implementation study, we estimated the effectiveness of MAb treatment within 7 days of symptom onset in high-risk ambulatory adults with COVID-19. The primary outcome was a composite of emergency department visit or hospitalization within 14 days of positive test. Secondary outcomes included adverse events and 14-day mortality. The average treatment effect in the treated for MAb therapy was estimated using inverse probability of treatment weighting and the impact of MAb implementation using propensity-weighted interrupted time series analysis. Results Pre-implementation (July-November, 2020), 7404 qualifying patients were identified. Post-implementation (December 2020-January 2021), 594 patients received MAb treatment and 5536 did not. The primary outcome occurred in 75 (12.6%) MAb recipients, 1018 (18.4%) contemporaneous controls and 1525 (20.6%) historical controls. MAb treatment was associated with decreased likelihood of emergency care or hospitalization, odds ratio 0.69 (95% CI 0.60-0.79). After implementation, the weighted probability that a given patient would require an emergency department visit or hospitalization decreased significantly (0.7% per day, 95% CI 0.03%-0.10%). Mortality was 0.2% (n=1) in the MAb group compared to 1.0% (n=71) and 1.0% (n=57) in pre- and post-implementation controls, respectively. Adverse events occurred in 7 (1.2%); 2 (0.3%) were considered serious. Conclusions MAb treatment of high-risk ambulatory patients with early COVID-19 was well-tolerated and likely effective at preventing the need for subsequent emergency department or hospital care.

Bamlanivimab and Etesevimab administered in an outpatient setting for SARS-CoV-2 infection

“…Although the sample size and the study design of this work are not appropriate to draw conclusions regarding clinical factors associated with negative outcomes of mAb administration, in this series, more than 90% of patients did not require inpatient care after mAb therapy (including only symptomatic patients, according to inclusion criteria). This is in line with clinical trials, and several ‘real life’ experiences now available in literature [ 12–14 ]; 16–19 ] showing the efficacy of mAb in reducing risk of hospitalization; however, possible risk factors for mAb treatment failure need to be investigated.…”

Real World Evidence of Neutralizing Monoclonal Antibodies for Preventing Hospitalization and Mortality in COVID-19 Outpatients

“…7 Consequently, studies of mAbs following EUA have primarily been small observational trials, confirming reduced hospitalization rates but not large enough to detect a mortality benefit nor to assess any potential heterogeneity of mAb treatment effects by comorbid conditions or vaccination status. [8][9][10] The latter information could be especially useful in policymaking about how best to allocate limited access to mAb treatment during shortages. 11,12 Furthermore, no published studies have yet directly evaluated the effectiveness of currently available mAbs against the Delta variant of SARS-CoV-2, which arose in summer 2021 in the US.…”

Combinations of drugs might increase the survival chances of COVID-19 patients: Literature review till date

“…Webb et.al conducted a trial of administering (Neutralizing monoclonal antibodies) mAb in 594 patients out of 7404 patients and reported that MAb treatment of high-risk ambulatory patients with early COVID-19 was well tolerated and likely effective at preventing the need for subsequent emergency department or hospital care [2048]. Piccicacco et.al reported that among high-risk COVID-19 patients with mild/moderate symptoms, early administration of mAbs potentially reduced the illness [2049].…”