Status:
UNKNOWN
Immunity and Safety of Covid-19 Synthetic Minigene Vaccine
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Collaborating Sponsors:
Shenzhen Third People's Hospital
Shenzhen Second People's Hospital
Conditions:
Pathogen Infection Covid-19 Infection
Eligibility:
All Genders
6-80 years
Phase:
PHASE1
PHASE2
Brief Summary
In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, maki...
Detailed Description
Background: The 2019 discovered new coronavirus, Covid-19, is an enveloped positive strand single strand RNA virus. The number of Covid-19 infected people has increased rapidly and WHO has warned that...
Eligibility Criteria
Inclusion
- Laboratory (RT-PCR) confirmed Covid-19 infection in throat swab and/or sputum and/or lower respiratory tract samples;
- The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
- White blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl;
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test is negative;
- Sign the Informed Consent Form on a voluntary basis;
Exclusion
- Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive).
- Subject is albumin-intolerant.
- Subject with life expectancy less than 4 weeks.
- Subject participated in other investigational somatic cell therapies within past 30 days.
- Subject with positive pregnancy test result.
- Researchers consider unsuitable.
Key Trial Info
Start Date :
March 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04276896
Start Date
March 24 2020
End Date
December 31 2024
Last Update
March 19 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
2
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518000
3
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China, 518000