Why carry out this study?

There is a continuing need for effective coronavirus disease 2019 (COVID-19) treatments to prevent severe disease and persistent symptoms, and reduce risk of hospitalization and death in at-risk individuals.

The TACKLE phase 3 outpatient treatment study showed that a single 600 mg intramuscular administration of AZD7442 (tixagevimab/cilgavimab) within 7 days of symptom onset significantly reduced progression to severe COVID-19 or death through day 29. Here, we present secondary efficacy endpoints and longer-term safety data.

What was learned from this study?

In unvaccinated individuals with mild-to-moderate COVID-19, 600 mg of AZD7442 reduced death from any cause and COVID-19-related hospitalization through 6 months and reduced COVID-19 symptom burden through 29 days; however, the study was conducted prior to emergence of Omicron.

AZD7442 was well tolerated through 6 months, safety was consistent with prior studies, and there was no increased risk of cardiac severe adverse events.

These extended follow-up data confirm the findings of the TACKLE primary analysis and suggest that intramuscular administration of virus-specific antibodies can be used to treat patients with mild-to-moderate COVID-19 in an outpatient setting.