COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04668339

Arcturus Therapeutics

clinicaltrials@arcturusrx.com

2020-12-16

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: individuals who: are able to provide consent agree to comply with all study visits and procedures are willing and able to adhere to study restrictions are sexually active and willing to adhere to contraceptive requirements are male or female ≥18 or (in singapore) ≥21 years of age are medically stable

individuals who: have had sars-cov-2 infection or covid-19 disease. have had cancer except for cancers that were treated and that have low risk of returning have chronic kidney disease have some chronic lung diseases have some heart conditions have compromised immune systems are obese have sickle cell disease or some other blood disorders are current smokers and/or use illegal drugs have type 2 diabetics are immunocompromised, immunodeficient or have had a transplant have autoimmune disease have other severe or uncontrolled diseases or disease that may interfere with the interpretation of the study have a positive test for hepatitis b or c or human immunodeficiency virus have had a severe reaction to previous investigational vaccines have a fever or are feeling sick close to the time of the first vaccination of the study have positive drug test at screening are pregnant are breastfeeding have a bleeding disorder have previously received an investigational coronavirus vaccine (sars-cov(1) or mers) or who plan to be in other covid-19 studies have recently been vaccinated with other vaccines have recently received blood products who work at one of the clinic sites participating in this study, work at arcturus, who work at other companies that monitor the study or close family members to the sites, arcturus, or partners involved in study monitoring other restrictions may apply

4

Arcturus Therapeutics, Inc.

18

100

Singapore;United States

Healthy volunteers

N/A

581

Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs;Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels;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 chemistry and hematology values;SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

None

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Single dose priming ", "treatment_id": 1901, "treatment_name": "Arct-021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Two lower dose priming ", "treatment_id": 1901, "treatment_name": "Arct-021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Two higher dose priming ", "treatment_id": 1901, "treatment_name": "Arct-021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]