COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04728347

Not reported

Not reported

2021-01-28

Terminated

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: individuals who: are able to give consent must have completed study arct-021-01 agree to comply with all study visits and procedures only for subjects that will receive arct-021 in this study: are healthy and medically stable are not planning to donate blood or plasma until 28 days after the last dose of arct-021. are willing to refrain from strenuous exercise/activity and alcohol for at least 72 hours prior to study visits and until 28 days after the last dose of arct-021. are willing to adhere to contraception requirements if sexually active and/or are of child-bearing potential

individuals who: are unable to comply with the study visits or procedures in study arct-021-01 received placebo in the parent study and who are not willing to receive arct-021 in this study. only for subjects that will receive arct-021 in this study: have or will receive any of the sars cov-2 or another experimental coronavirus during this study. have a diagnosis of new clinically significant abnormalities including but not limited to respiratory disease requiring daily medications or oxygen currently or any treatment of respiratory disease exacerbations significant heart conditions significant neurological conditions significant blood disorders newly diagnosed autoimmune disease major surgery have abnormal screening laboratory results have uncontrolled diabetes use of any prescription or over-the-counter medications within 7 days prior to vaccination have received immunoglobulins and/or any blood or blood products have a bleeding disorder have uncontrolled blood pressure have been treated with another investigational drug, biological agent, or device since completion of the parent study have received or plan to receive: a licensed, live vaccine within 4 weeks before or after study vaccination, or a licensed, inactivated vaccine within 2 weeks before or after study vaccination have traveled outside of singapore within 30 days before the vaccination or plans to travel outside of singapore within 60 days after vaccination. other restrictions may apply

2

Arcturus Therapeutics, Inc.

21

80

Singapore

Healthy volunteers

N/A

65

Percentages of participants reporting adverse events;Percentages of participants reporting medically attended adverse events;Percentages of participants reporting new onset of chronic disease;Percentages of participants reporting serious adverse events;Percentages of participants reporting solicited local adverse events;Percentages of participants reporting solicited systemic adverse events;Percentages of participants with abnormal safety laboratory test values;Percentages of participants with abnormal vital sign assessments

None

Phase 2

[{"arm_notes": "", "treatment_id": 1901, "treatment_name": "Arct-021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]