Phase 3
Completed N=1,455
AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Source: ClinicalTrials.gov NCT05780437 ↗Enrolled (actual)
1,455
Serious AEs
5.3%
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants With Sustained Recovery — 617; 594 Participants
◆ Published Evidence
Highly cited
128citations · ~32 / year
Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial.
Summary
This study looks at the safety and effectiveness of AZD7442 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H4.
Linked Publications
-
Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Recovery |
617; 594 | — |
| PRIMARY Number of Participants With an Ordinal Outcome on Day 5 |
10; 13; 32; 29; 102; 99 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 5 |
181; 202 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 28 |
226; 250 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 90 |
179; 214 | — |
| SECONDARY Number of Participants Who Died From All Causes |
61; 86 | — |
Eligibility Criteria
Inclusion Criteria
- Refer to the master protocol (NCT04501978)
Exclusion Criteria
- Refer to the master protocol (NCT04501978)
- Additional Exclusion Criteria:
- Pregnant women
- Nursing mothers
- Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through the entire 18 months of the study
- Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through the entire 18 months of the study.
- In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on AZD7442 and 150 on placebo, patients on high-flow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this agent.
Data sourced from ClinicalTrials.gov (NCT05780437) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.