Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791423
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2021-02-22
Brief Title:
Study of GRAd-COV2 for the Prevention of COVID-19 in Adults
Sponsor:
ReiThera Srl
Organization:
ReiThera Srl
Study Overview
Official Title:
A Phase IIIII Randomized Stratified Observer-Blind Placebo-Controlled Study to Evaluate the Efficacy Safety and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVITAR
Brief Summary:
Multicenter Study assessing the safety efficacy and immunogenicity of the candidate vaccine GRAd-COV2 compared to placebo for the prevention of COVID-19 Participants will be adults 18 years of age who are healthy or have medically stable chronic diseases and are at increased risk for SARS-CoV-2 acquisition and COVID-19 In the phase II part approximately 900 participants will be randomized in a 111 ratio to receive i 2 repeated 21 days apart intramuscular IM doses of GRAd-COV2 at 1x1011 viral particle vp n approximately 300 subjects ii 1 single IM dose of GRAd-COV2 at 2x1011 vp plus 1 dose of placebo after 21 days n approximately 300 subject or 2 doses of placebo n approximately 300 subjects on day 1 and day 22 There will be 3 strata for randomization 65 years 65 years and categorized to be at increased risk at risk for the complications of COVID-19 and 65 years not at risk Risk will be defined referring to the study participants relevant past and current medical history An independent Data Safety Monitoring Board will provide oversight to ensure safe and ethical conduct of the Study a Steering Committee will revise safety data collected for 900 participants 1 week after dosing and immunogenicity data collected for 450 participants 5 weeks after the first dosing generated in phase II part Jointly DSMB and SC will recommend the expansion to phase III and the best regimen to be used
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None