NCT05321394

Non-inferiority Trial on Treatments in Early COVID-19

Adaptive, Randomized, Non-inferiority Trial on the Use of Monoclonal Antibodies or Antivirals in Outpatients With Mild or Moderate COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 536 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The study aims at assessing the non-inferiority of tixagevimab plus cilgavimab and nirmatrelvir plus ritornavir vs. sotrovimab (reference standard due to the wider evidence gathered on its efficacy) on COVID-19 progression in a real-life setting of outpatients aged at least 50 years at an early stage of the disease. The progression of COVID-19 disease (hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of randomisation is the composite outcome variable on which the calculation of the sample size is based. Based on available data regarding the reduction in the number of hospitalisations and medical visits with the use of sotrovimab at an early-stage of COVID-19, a disease progression of 1% has been estimated in the reference arm. 3% delta margin was considered clinically relevant, taking into account both the estimates of disease progression in the study population in absence of early treatment (7%, based on national data) and the efficacy of the reference standard. Therefore, 1095 participants will be randomly assigned in an equal ratio between the reference standard and each of the other two experimental arms (1:1:1). Randomization will be computer-generated in permuted blocks with a stratification based on site.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Sotrovimab	Single intravenous infusion of sotrovimab 500 mg (500 mg/8 mL), administered in 100 mL prefilled 0.9% sodium chloride injection infusion solution over 1/2 hour.
DRUG	Tixagevimab Cilgavimab	2 subsequent injections: 1. tixagevimab 300mg/3mL (100mg/mL) 2. cilgavimab 300mg/3mL (100mg/mL)
DRUG	Nirmatrelvir Ritonavir	300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) with all three tablets taken together twice daily for 5 days

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-10-29
• Completion: 2023-10-29
• First posted: 2022-04-11
• Last updated: 2023-11-07

Locations

19 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study