Outpatient treatment with AZD7442 (tixagevimab/cilgavimab) prevented Covid-19 hospitalizations over 6 months and reduced symptom progression in the TACKLE randomized trial
<p><b>Introduction</b></p> 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. <p><...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Springer
2023
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| _version_ | 1811139173292179456 |
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| author | Hobbs, FDR Montgomery, H Padilla, F Simón-Campos, JA Kim, K Arbetter, D Padilla, KW Reddy, VP Seegobin, S Streicher, K Templeton, A Viani, RM Johnsson, E Koh, GCKW Esser, MT |
| author_facet | Hobbs, FDR Montgomery, H Padilla, F Simón-Campos, JA Kim, K Arbetter, D Padilla, KW Reddy, VP Seegobin, S Streicher, K Templeton, A Viani, RM Johnsson, E Koh, GCKW Esser, MT |
| author_sort | Hobbs, FDR |
| collection | OXFORD |
| description | <p><b>Introduction</b></p>
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.
<p><b>Methods</b></p>
Participants received 600 mg AZD7442 (n = 452) or placebo (n = 451) ≤ 7 days of COVID-19 symptom onset.
<p><b>Results</b></p>
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.
<p><b>Conclusions</b></p>
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.
<p><b>Clinical Trial Registration</b></p>
Clinicaltrials.gov, NCT04723394. (https://beta.clinicaltrials.gov/study/NCT04723394). |
| first_indexed | 2024-09-25T04:01:52Z |
| format | Journal article |
| id | oxford-uuid:7d24b752-494c-4f0f-831b-75d36ec47cdb |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-09-25T04:01:52Z |
| publishDate | 2023 |
| publisher | Springer |
| record_format | dspace |
| spelling | oxford-uuid:7d24b752-494c-4f0f-831b-75d36ec47cdb2024-04-30T12:37:25ZOutpatient treatment with AZD7442 (tixagevimab/cilgavimab) prevented Covid-19 hospitalizations over 6 months and reduced symptom progression in the TACKLE randomized trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:7d24b752-494c-4f0f-831b-75d36ec47cdbEnglishSymplectic ElementsSpringer2023Hobbs, FDRMontgomery, HPadilla, FSimón-Campos, JAKim, KArbetter, DPadilla, KWReddy, VPSeegobin, SStreicher, KTempleton, AViani, RMJohnsson, EKoh, GCKWEsser, MT<p><b>Introduction</b></p> 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. <p><b>Methods</b></p> Participants received 600 mg AZD7442 (n = 452) or placebo (n = 451) ≤ 7 days of COVID-19 symptom onset. <p><b>Results</b></p> 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. <p><b>Conclusions</b></p> 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. <p><b>Clinical Trial Registration</b></p> Clinicaltrials.gov, NCT04723394. (https://beta.clinicaltrials.gov/study/NCT04723394). |
| spellingShingle | Hobbs, FDR Montgomery, H Padilla, F Simón-Campos, JA Kim, K Arbetter, D Padilla, KW Reddy, VP Seegobin, S Streicher, K Templeton, A Viani, RM Johnsson, E Koh, GCKW Esser, MT Outpatient treatment with AZD7442 (tixagevimab/cilgavimab) prevented Covid-19 hospitalizations over 6 months and reduced symptom progression in the TACKLE randomized trial |
| title | Outpatient treatment with AZD7442 (tixagevimab/cilgavimab) prevented Covid-19 hospitalizations over 6 months and reduced symptom progression in the TACKLE randomized trial |
| title_full | Outpatient treatment with AZD7442 (tixagevimab/cilgavimab) prevented Covid-19 hospitalizations over 6 months and reduced symptom progression in the TACKLE randomized trial |
| title_fullStr | Outpatient treatment with AZD7442 (tixagevimab/cilgavimab) prevented Covid-19 hospitalizations over 6 months and reduced symptom progression in the TACKLE randomized trial |
| title_full_unstemmed | Outpatient treatment with AZD7442 (tixagevimab/cilgavimab) prevented Covid-19 hospitalizations over 6 months and reduced symptom progression in the TACKLE randomized trial |
| title_short | Outpatient treatment with AZD7442 (tixagevimab/cilgavimab) prevented Covid-19 hospitalizations over 6 months and reduced symptom progression in the TACKLE randomized trial |
| title_sort | outpatient treatment with azd7442 tixagevimab cilgavimab prevented covid 19 hospitalizations over 6 months and reduced symptom progression in the tackle randomized trial |
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