tetano
Editor, Senior Moderator
Infect Dis Ther
. 2023 Sep 26.
doi: 10.1007/s40121-023-00861-7. Online ahead of print. Outpatient Treatment with AZD7442 (Tixagevimab/Cilgavimab) Prevented COVID-19 Hospitalizations over 6 Months and Reduced Symptom Progression in the TACKLE Randomized Trial
F D Richard Hobbs[SUP] 1 [/SUP], Hugh Montgomery[SUP] 2 [/SUP], Francisco Padilla[SUP] 3 [/SUP], Jesus Abraham Simón-Campos[SUP] 4 [/SUP], Kenneth Kim[SUP] 5 [/SUP], Douglas Arbetter[SUP] 6 [/SUP], Kelly W Padilla[SUP] 7 [/SUP], Venkatesh Pilla Reddy[SUP] 8 [/SUP], Seth Seegobin[SUP] 9 [/SUP], Katie Streicher[SUP] 10 [/SUP], Alison Templeton[SUP] 9 [/SUP], Rolando M Viani[SUP] 11 [/SUP], Eva Johnsson[SUP] 12 [/SUP], Gavin C K W Koh[SUP] 13 [/SUP], Mark T Esser[SUP] 14 [/SUP]
Affiliations
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 ).
Keywords: AZD7442; COVID-19; Cilgavimab; Hospitalization; Monoclonal antibodies; SARS-CoV-2; Symptoms; Tixagevimab.
. 2023 Sep 26.
doi: 10.1007/s40121-023-00861-7. Online ahead of print. Outpatient Treatment with AZD7442 (Tixagevimab/Cilgavimab) Prevented COVID-19 Hospitalizations over 6 Months and Reduced Symptom Progression in the TACKLE Randomized Trial
F D Richard Hobbs[SUP] 1 [/SUP], Hugh Montgomery[SUP] 2 [/SUP], Francisco Padilla[SUP] 3 [/SUP], Jesus Abraham Simón-Campos[SUP] 4 [/SUP], Kenneth Kim[SUP] 5 [/SUP], Douglas Arbetter[SUP] 6 [/SUP], Kelly W Padilla[SUP] 7 [/SUP], Venkatesh Pilla Reddy[SUP] 8 [/SUP], Seth Seegobin[SUP] 9 [/SUP], Katie Streicher[SUP] 10 [/SUP], Alison Templeton[SUP] 9 [/SUP], Rolando M Viani[SUP] 11 [/SUP], Eva Johnsson[SUP] 12 [/SUP], Gavin C K W Koh[SUP] 13 [/SUP], Mark T Esser[SUP] 14 [/SUP]
Affiliations
- PMID: 37751015
- DOI: 10.1007/s40121-023-00861-7
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 ).
Keywords: AZD7442; COVID-19; Cilgavimab; Hospitalization; Monoclonal antibodies; SARS-CoV-2; Symptoms; Tixagevimab.