Monday, November 30, 2020 4:42:13 PM
They can start pre-screening today. If qualified, they will call back tomorrow after Ino green-lights. The participant will come in for a blood draw and COVID-19 viral test. The sample will be sent to a PCR lab. After result comes back negative, they will schedule the participant to come in to get first shot. This site will recruit 40 ppl. Recruiting will end 12/15/20 which synchronizes with China P2 trial. This means all participants will have first shot by 12/15/20. Then the study will be updated with “Active, not Recruiting”.
https://clinicaltrials.gov/ct2/show/NCT04642638#contacts
San Diego, California, United States, 92108
Contact: Prinicipal Investigator Patrick Yassini pyassini@optimalsites.net
5920 Friars Rd UNIT 200, San Diego, CA 92108
Located in: PARK PLACE PLAZA
Open · Closes 5PM
(619) 291-2845
Official-INO-4800-P2-start-in-China-Recruiting-11/27-12/15, 640 ppl, 18-85 yrs old
Registration number:
ChiCTR2000040146
Date of Last Refreshed on:
2020-11-22
Date of Registration:
2020-11-22
Registration Status:
Prospective registration
Public title:
A Phase II, Randomized, Double-blinded, Placebo-controlled, Dose-finding Clinical Study to Evaluate the Safety and Immunogenicity of Different Doses of INO-4800 Administered Intradermally Followed by Electroporation in Healthy Adult and Elderly Volunteers
Objectives of Study:
Primary objectives: ? To evaluate the safety and tolerability of INO-4800 at different dose levels in healthy subjects (= 18 and < 60 years old as well as = 60 and = 85 years old); ? To evaluate the humoral immune response of INO-4800 at different doses in healthy subjects (= 18 and < 60 years old as well as = 60 and = 85 years old). Secondary objective: ? To evaluate the duration of humoral response of INO-4800 at different doses in healthy subjects at different ages ((= 18 and < 60 years old as well as = 60 and = 85 years old). Exploratory objective: ? To evaluate the cellular immune response of INO-4800 at different doses in healthy subjects ((= 18 and < 60 years old as well as = 60 and = 85 years old).
Study execute time:
From 2020-11-27 To 2020-12-15
Recruiting time:
From 2020-11-27 To 2020-12-15
Group:2
Sample size:640
Country: China
Province:Jiangsu
Hospital: Danyang City Center for Disease Control and Prevention
http://www.chictr.org.cn/showprojen.aspx?proj=64452
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