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Trial - NCT04567810


Column Value
Trial registration number NCT04567810
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04567810

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Michaela Lucas, MD

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

contactus@linear.org.au

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-29

Recruitment status
Last imported at : Dec. 23, 2020, 12:31 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

Sequential assignment

Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - healthy males or non-pregnant, non-lactating females - body weight of at least 50 kg - good state of health (mentally and physically) - must agree to use of highly effective method of contraception

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- received other investigational drug within the last 30 days prior to screening - history of drug or alcohol abuse in the past 2 years (>21 units of alcohol per week for males and >14 units of alcohol per week for females) - current smoker / e-smoker - abnormal kidney function - abnormal liver function - positive for hepatitis b or c infection - positive for hiv infection - positive for sars-cov-2 infection - history of egg allergy - abnormal cardiac function

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

7

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Stanford University

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

45

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Australia

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

48

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Number of participants with treatment-related adverse events

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 1

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "2mg", "treatment_id": 100, "treatment_name": "Anti-sars-cov-2 igy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "4mg", "treatment_id": 100, "treatment_name": "Anti-sars-cov-2 igy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "8mg", "treatment_id": 100, "treatment_name": "Anti-sars-cov-2 igy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "6mg", "treatment_id": 100, "treatment_name": "Anti-sars-cov-2 igy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "12mg", "treatment_id": 100, "treatment_name": "Anti-sars-cov-2 igy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "24mg", "treatment_id": 100, "treatment_name": "Anti-sars-cov-2 igy", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]