COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT05603052


Column Value
Trial registration number NCT05603052
Full text link
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Collin Choi

Contact
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

collin.choi@eubiologics.com

Registration date
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

2022-11-02

Recruitment status
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 4, 2022, 8 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 : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

inclusion criteria: individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent female of childbearing potential who agree to use medically allowed methods of contraception during the study period individuals who agrees not to perform blood donation and transfusion during the study period

Exclusion criteria
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

individual being considered to be confirmed covid-19 direct contact with covid-19 infected person within 14 days prior to the 1st dose of the ip individuals at high risk of exposure to sars-cov-2 individuals with clinically significant abnormalities in clinical laboratory tests, ecgs, and chest x-ray during screening individuals with fever within 72 hours prior to the 1st dose of the ip or suspected other infectious disease or symptoms associated with other infectious disease individuals with serious medical or psychiatric disease history of sars-cov or mers-cov infection history of allergic reaction or hypersensitivity reactions to any of components of the ip history of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination history of receiving organ or bone marrow transplant suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination history of vaccination against sars-cov, mers-cov, or sars-cov-2 history of vaccination with test vaccine substance treatment with immunosuppressants or immune modifying drugs history of treatment with antipsychotics or opioid dependence pregnant or lactating women other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

Number of arms
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

EuBiologics Co.,Ltd

Inclusion age min
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Congo;The Democratic Republic of the

Type of patients
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

4000

primary outcome
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1;The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1

Notes
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : July 12, 2023, 8 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 486, "treatment_name": "Eucorvac-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 486, "treatment_name": "Eucorvac-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]