| Trial registration number
|
NCT04545060 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04545060
|
First author
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Vir Biotechnology, Inc. - Study Inquiry
|
Contact
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
clinicaltrials@vir.bio
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2020-09-10
|
Recruitment status
Last imported at : Sept. 28, 2021, 8 a.m.
Source : ClinicalTrials.gov
|
Completed
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Blind label
|
Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
multi-center
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
- participant must be aged 18 years or older 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 5 days from onset of
symptoms
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.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
- severely immunocompromised participants
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Vir Biotechnology, Inc.
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
100
|
Countries
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Austria;Brazil;Canada;Peru;Spain;United Kingdom;United States
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Mild/moderate disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2: Mild/moderate disease at enrollment
|
Total sample size
Last imported at : Sept. 28, 2021, 8 a.m.
Source : ClinicalTrials.gov
|
1057
|
primary outcome
Last imported at : Nov. 8, 2022, 4 p.m.
Source : ClinicalTrials.gov
|
Number of Participants Who Had Progression of COVID-19 Through Day 29
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
|
Phase 2/Phase 3
|
Arms
Last imported at : Nov. 8, 2022, 4 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "nan", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|