COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04783311

Not reported

Not reported

2021-03-05

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: individuals who voluntarily decide to participate in this study and provide written informed consent healthy male and female adult at the age of 19 to 50 years (part a) healthy male and female adult at the age of 19 to 75 years (part b) individuals who are available for all visit procedures including telephone visits during the study period

covid-19 positive based on rt-pcr using upper respiratory tract or lower respiratory tract sampling or covid-19 antibody positive history of sars-cov, mers-cov or sars-cov-2 infection history of vaccination against sars-cov, mers-cov or sars-cov-2 immune system disorders including immunodeficiency disease clinically significant abnormalities in clinical laboratory test, ecgs and chest x-ray during screening in the opinion of the investigator fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study history of severe allergic reactions or severe hypersensitivity reactions to the ip or any of its components history of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening women of childbearing potential who do not agree to use medically allowed methods of contraception or to be heterosexually inactive until 60 days after the last dose of the ip pregnant or breastfeeding woman treatment with other ips within 6 months prior to participation in this study other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

3

EuBiologics Co.,Ltd

19

75

Korea;Republic of

Healthy volunteers

N/A

279

AESIs;Immediate AEs;SAEs;Solicited local and systemic AEs;Unsolicited AEs

None

Phase 1/Phase 2

[{"arm_notes": "Low dose;2;Day0-21", "treatment_id": 486, "treatment_name": "Eucorvac-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High dose;2;Day0-21", "treatment_id": 486, "treatment_name": "Eucorvac-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]