COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04779879

Vir Biotechnology, Inc

clinicaltrials@vir.bio

2021-03-03

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - for part a, participants must be aged 18 years or older at the time of obtaining informed consent - for parts b and c, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent - participants who have a positive sars-cov-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have covid-19 symptoms and ≤7 days from onset of symptoms

- 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. - severely immunocompromised participants - for parts a and b, prior receipt of a sars-cov-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved sars-cov-2 vaccine will not be allowed for 90 days after dosing) - for parts b and c, conditions that would prohibit receipt of im injections in the investigator's opinion - for parts a, b and c, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved sars-cov-2 vaccine will not be allowed for 90 days after dosing)

2

Vir Biotechnology, Inc.

18

100

Canada;Italy;Republic of Korea;Spain;United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

354

Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29;Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29;Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29;Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29;Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8);Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8)

None

Phase 2

[{"arm_notes": "", "treatment_id": 1221, "treatment_name": "Sotrovimab (gen 1)", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1223, "treatment_name": "Sotrovimab (gen 2)", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}]