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Real-world Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients With Early COVID-19.
Webb, Brandon J; Buckel, Whitney; Vento, Todd; Butler, Allison M; Grisel, Nancy; Brown, Samuel M; Peltan, Ithan D; Spivak, Emily S; Shah, Mark; Sakata, Theadora; Wallin, Anthony; Stenehjem, Eddie; Poulsen, Greg; Bledsoe, Joseph.
  • Webb BJ; Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Buckel W; Division of Infectious Diseases and Geographic Medicine, Stanford Medicine, Palo Alto, California, USA.
  • Vento T; Pharmacy Services, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Butler AM; Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Grisel N; Enterprise Analytics, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Brown SM; Enterprise Analytics, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Peltan ID; Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah, USA.
  • Spivak ES; Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah, USA.
  • Shah M; Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, Utah, USA.
  • Sakata T; Department of Emergency Medicine, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Wallin A; Urgent Care Service Line, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Stenehjem E; Urgent Care Service Line, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Poulsen G; Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah, USA.
  • Bledsoe J; Division of Infectious Diseases and Geographic Medicine, Stanford Medicine, Palo Alto, California, USA.
Open Forum Infect Dis ; 8(7): ofab331, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1334239
ABSTRACT

BACKGROUND:

Neutralizing monoclonal antibodies (MAbs) are a promising therapy for early coronavirus disease 2019 (COVID-19), but their effectiveness has not been confirmed in a real-world setting.

METHODS:

In this quasi-experimental pre-/postimplementation 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 visits or hospitalizations 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. Postimplementation (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 with 1.0% (n = 71) and 1.0% (n = 57) in pre- and postimplementation 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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study Language: English Journal: Open Forum Infect Dis Year: 2021 Document Type: Article Affiliation country: Ofid

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study Language: English Journal: Open Forum Infect Dis Year: 2021 Document Type: Article Affiliation country: Ofid