Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Vir Biotechnology

Status and phase: Terminated; Phase 3

Conditions: Covid19

Treatments: Biological: Sotrovimab; Biological: sotrovimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04913675

VIR-7831-5008

Details and patient eligibility

About

The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression

Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

Enrollment: 1,065 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Main Study participant must be aged 12 years or older AND at high risk of progression of COVID-19 or > 55 years old
• Sub-Study participants must be aged 18 years or older at time of consent AND at high risk of progression of COVID-19 or ≥ 55 years old
• Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 7 days from onset of symptoms

Exclusion criteria

• Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
• Symptoms consistent with severe COVID-19
• Participants who, in the judgement of the investigator are likely to die in the next 7 days
• Known hypersensitivity to any constituent present in the investigational product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,065 participants in 7 patient groups

Main Study - Sotrovimab 500 mg IV

Active Comparator group

Treatment:

Biological: sotrovimab

Biological: sotrovimab

Biological: sotrovimab

Biological: sotrovimab

Main Study - Sotrovimab 500 mg IM

Experimental group

Treatment:

Biological: sotrovimab

Biological: sotrovimab

Biological: sotrovimab

Biological: sotrovimab

Main Study - Sotrovimab 250 mg IM

Experimental group

Treatment:

Biological: sotrovimab

Biological: sotrovimab

Biological: sotrovimab

Biological: sotrovimab

Substudy (Cohort A) - Sotrovimab 2000 mg IV

Experimental group

Treatment:

Biological: sotrovimab

Biological: sotrovimab

Biological: sotrovimab

Biological: sotrovimab

Substudy (Optional Cohort B1) - Sotrovimab 2000 mg IV

Experimental group

Treatment:

Biological: Sotrovimab

Biological: Sotrovimab

Biological: Sotrovimab

Substudy (Optional Cohort B2) - Sotrovimab 2000 mg IV

Experimental group

Treatment:

Biological: Sotrovimab

Biological: Sotrovimab

Biological: Sotrovimab

Substudy (Optional Cohort C) - Sotrovimab up to 3000 mg IV

Experimental group

Treatment:

Biological: Sotrovimab

Biological: Sotrovimab

Biological: Sotrovimab