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| Column | Value |
|---|---|
| Trial registration number | NCT04913675 |
|
Full text link
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
clinicaltrials@vir.bio |
|
Registration date
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-06-04 |
|
Recruitment status
Last imported at : March 8, 2024, 8 p.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Aug. 25, 2023, 4 a.m. Source : ClinicalTrials.gov |
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
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- 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 |
|
Number of arms
Last imported at : May 30, 2023, 3:29 p.m. Source : ClinicalTrials.gov |
7 |
|
Funding
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Vir Biotechnology, Inc. |
|
Inclusion age min
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
12 |
|
Inclusion age max
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
France;Ukraine;United States |
|
Type of patients
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : Aug. 25, 2023, 4 a.m. Source : ClinicalTrials.gov |
1065 |
|
primary outcome
Last imported at : Aug. 25, 2023, 4 a.m. Source : ClinicalTrials.gov |
Main Study: Percentage of Participants Who Had Progression of Coronavirus Disease 2019 (COVID-19) Through Day 29 by Hospitalization >24 Hours or Death Due to Any Cause (Weekly and Daily Imputation);Safety Sub-study: Number of Participants With Any Disease Related Events Through Day 8;Safety Sub-study: Number of Participants With Infusion-related Reaction Including Hypersensitivity Through Day 8;Safety Sub-study: Number of Participants With Non-Serious Adverse Events (Non-SAE) and Serious Adverse Events (SAEs) Through Day 8 |
|
Notes
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 8, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : May 30, 2023, 3:29 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "500 mg given by intravenous infusion over 15 min", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "500 mg given by intramuscular injection", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "250 mg given by intramuscular injection", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "2000 mg given by intravenous infusion over 60 min", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "2000 mg given by intravenous infusion over 30 min", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "2000 mg given by intravenous infusion over 15 min", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "3000 mg given by intravenous infusion over 90 min", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}] |