Status:
TERMINATED
Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
Lead Sponsor:
Arcturus Therapeutics, Inc.
Conditions:
SARS-CoV-2
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
This is an open-label study enrolling healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will receive either a single injection of ARCT-021 or no injection and be f...
Detailed Description
This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04728347
Start Date
January 4 2021
End Date
December 28 2021
Last Update
December 30 2024
Active Locations (1)
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1
SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital
Singapore, Singapore, 169608