COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04863131

Yohei Doi

Not reported

2021-04-28

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - has provided written consent for participation - age between 20 and 55 - has a negative nucleic acid-based test result for sars-cov-2 - has a negative antibody test result for sars-cov-2

- signs and symptoms consistent with covid-19 upon screening - history of covid-19 - presence of uncontrolled cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease - presence of diabetes mellitus - presence of active autoimmune disease - positive for hbc, hcv or hiv antibody - history of anaphylactic shock - history of epilepsy - presence of active malignancy - presence of lung disease (e.g., copd, asthma) - positive urine pregnancy test within 24 hours - pregnant, lactating, planned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug - if female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug - if male, not agreeable to contraception for 90 days after second administration of the trial drug - presence of clinically relevant electrocardiogram or vital sign abnormality at screening - participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days - received any sars-cov-2 vaccine - received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product - received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties - received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid - deemed ineligible for the study as determined by the principal investigator or a co-investigator

2

Fujita Health University

20

55

Japan

Healthy volunteers

N/A

40

Number of Participants Reporting Local and Systemic Adverse Events

None

Phase 1/Phase 2

[{"arm_notes": "1", "treatment_id": 489, "treatment_name": "Exg-5003", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]