v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04896541 |
|
Full text link
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
information.center@astrazeneca.com |
|
Registration date
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-21 |
|
Recruitment status
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - participants must be japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent. - negative results from both sars-cov-2 qrt-pcr and serology tests - healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators |
|
Exclusion criteria
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- fever above 37.5°c by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation. - history of infection with sars or mers - any drug therapy within 7 days prior to day 1 |
|
Number of arms
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
5 |
|
Funding
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
AstraZeneca |
|
Inclusion age min
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
55 |
|
Countries
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Japan |
|
Type of patients
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
40 |
|
primary outcome
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Adverse event and serious adverse event;Pharmacokinetics - Area under the plasma concentration-time curve extrapolated to infinity;Pharmacokinetics - Area under the plasma concentration-time curve to the last measurable time point;Pharmacokinetics -bioavailability;Pharmacokinetics - extravascular systemic clearance;Pharmacokinetics -extravascular terminal phase volume of distribution;Pharmacokinetics - Maximum Serum Concentration;Pharmacokinetics - Serum Concentration;Pharmacokinetics - Time to Maximum Serum Concentration |
|
Notes
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "300 mg IM (male)", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "300 mg IV (male and female)", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "600 mg IM (male)", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1000 mg IV (male)", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |