Why carry out this study? |
There is an ongoing need for effective coronavirus disease 2019 (COVID-19) treatments to prevent severe disease and reduce the risk of hospitalization and death in at-risk individuals. |
What did the study ask? |
The TACKLE study evaluated the efficacy and safety of a single intramuscular injection of 600 mg AZD7442 (tixagevimab/cilgavimab) in outpatients with mild-to-moderate COVID-19 administered within 7 days of symptom onset. |
What was learned from this study? |
The final 15-month analysis of TACKLE confirmed the efficacy of AZD7442 in reducing progression to severe COVID-19 or death through day 29 and death from any cause or hospitalization for COVID-19 complications or sequelae through day 169. |
The safety profile of AZD7442 over 15 months of follow-up was comparable with placebo and consistent with that observed in prior reports of shorter duration. |
These long-term follow-up data confirm the findings of the TACKLE primary and key secondary analyses and suggest that intramuscular injection of long-acting therapeutic monoclonal antibodies can be used to treat outpatients with mild-to-moderate COVID-19. |
Digital Features
Introduction
Methods
Trial Overview
Ethical Approval
Randomization and Masking
Endpoints
Protocol Amendments
Statistical Analyses
Results
Trial Population
Efficacy
Primary Efficacy Endpoint: Severe COVID-19 or Death from Any Cause Through Day 29
Key Secondary Efficacy Endpoint: Death from Any Cause or Hospitalizations for COVID-19 Complications or Sequelae Through Day 169
Secondary Efficacy Endpoint: SARS-CoV-2 RNA Detected in Nasal Swabs up to Day 29
Safety
Event | AZD7442 (N = 452) | Placebo (N = 451) |
---|---|---|
AE, n (%) | 251 (55.5) | 252 (55.9) |
COVID-19 | 51 (11.3) | 51 (11.3) |
Post-acute COVID-19 syndrome | 38 (8.4) | 29 (6.4) |
COVID-19 pneumonia | 26 (5.8) | 49 (10.9) |
Grade 3–4 AE, n (%) | 33 (7.3) | 51 (11.3) |
COVID-19 pneumonia | 19 (4.2) | 29 (6.4) |
COVID-19 reinfection within 6 months, n (%) | 1 (0.2) | 2 (0.4) |
AE leading to study withdrawal, n (%) | 5 (1.1) | 8 (1.8) |
SAE, n (%) | 46 (10.2) | 65 (14.4) |
Related SAEa, n (%) | 0 | 0 |
AESIb, n (%) | 19 (4.2) | 17 (3.8) |
Injection site reactionsc | 14 (3.1) | 13 (2.9) |
Death, n (%) | 8 (1.8) | 8 (1.8) |
Acute left ventricular failure | 1 (0.2) | 0 |
Cardiac arrest | 0 | 1 (0.2) |
Death | 0 | 1 (0.2) |
Sudden cardiac death | 1 (0.2) | 0 |
COVID-19 pneumonia | 2 (0.4) | 4 (0.9) |
COVID-19 | 1 (0.2) | 1 (0.2) |
Septic shock | 0 | 1 (0.2) |
Road traffic accident | 1 (0.2) | 0 |
Colorectal cancer metastasis | 1 (0.2) | 0 |
Gastric cancer | 1 (0.2) | 0 |