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Outpatient Treatment with AZD7442 (Tixagevimab/Cilgavimab) Prevented COVID-19 Hospitalizations over 6 Months and
F D Richard Hobbs1, Hugh Montgomery2, Francisco Padilla3
1Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Insights
AZD7442 (tixagevimab/cilgavimab) significantly reduced deaths and hospitalizations from COVID-19 by nearly 50% in outpatients. This treatment also lessened symptom severity within 29 days, demonstrating its effectiveness in managing coronavirus disease 2019.
Area of Science:
- Infectious Diseases
- Immunology
- Pharmacology
Background:
- The TACKLE study evaluated AZD7442 (tixagevimab/cilgavimab) in adult outpatients with COVID-19.
- Assessed were effects on mortality, hospitalization, symptom severity, and safety.
Purpose of the Study:
- To determine the efficacy of AZD7442 in preventing severe outcomes of COVID-19.
- To evaluate the impact of AZD7442 on symptom duration and severity.
- To assess the longer-term safety profile of AZD7442 in an outpatient setting.
Main Methods:
- Adult outpatients with COVID-19 received either 600 mg of AZD7442 (n=452) or a placebo (n=451).
- Treatment was administered within 7 days of symptom onset.
- Safety and efficacy endpoints were monitored up to 169 days post-treatment.
Main Results:
- AZD7442 reduced the composite endpoint of death from any cause or hospitalization due to COVID-19 by 49.1% (p=0.009).
- Symptom progression was reduced by 12.5% (p=0.006) through day 29, with most symptoms improving within 1-2 weeks.
- Adverse events were comparable between the AZD7442 and placebo groups (38.5% vs 43.5%), with rare cardiac serious adverse events.
Conclusions:
- AZD7442 demonstrated a significant reduction in hospitalization and mortality for up to six months in mild-to-moderate COVID-19 outpatients.
- The treatment effectively reduced symptom burden within 29 days.
- AZD7442 was well-tolerated, indicating a favorable safety profile.
Introduction:
We assessed effects of AZD7442 (tixagevimab/cilgavimab) on deaths from any cause or hospitalizations due to coronavirus disease 2019 (COVID-19) and symptom severity and longer-term safety in the TACKLE adult outpatient treatment study.
Methods:
Participants received 600 mg AZD7442 (n = 452) or placebo (n = 451) ≤ 7 days of COVID-19 symptom onset.
Results:
Death from any cause or hospitalization for COVID-19 complications or sequelae through day 169 (key secondary endpoint) occurred in 20/399 (5.0%) participants receiving AZD7442 versus 40/407 (9.8%) receiving placebo [relative risk reduction (RRR) 49.1%; 95% confidence interval (CI) 14.5, 69.7; p = 0.009] or 50.7% (95% CI 17.5, 70.5; p = 0.006) after excluding participants unblinded before day 169 for consideration of vaccination). AZD7442 reduced progression of COVID-19 symptoms versus placebo through to day 29 (RRR 12.5%; 95% CI 0.5, 23.0) and improved most symptoms within 1-2 weeks. Over median safety follow-up of 170 days, adverse events occurred in 174 (38.5%) and 196 (43.5%) participants receiving AZD7442 or placebo, respectively. Cardiac serious adverse events occurred in two (0.4%) and three (0.7%) participants receiving AZD7442 or placebo, respectively.
Conclusions:
AZD7442 was well tolerated and reduced hospitalization and mortality through 6 months, and symptom burden through 29 days, in outpatients with mild-to-moderate COVID-19.
Clinical Trial Registration:
Clinicaltrials.gov, NCT04723394. ( https://beta.
Clinicaltrials:
gov/study/NCT04723394 ).
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