Trial registration number
|
TCTR20210628005 |
Full text link
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
https://www.thaiclinicaltrials.org/show/TCTR20210628005
|
First author
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Nasamon Wanlapakorn
|
Contact
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
nasamon.w@chula.ac.th
|
Registration date
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2021-06-28
|
Recruitment status
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not recruiting
|
Study design
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
nonRCT
|
Allocation
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Non-randomized
|
Design
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Parallel
|
Masking
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Open label
|
Center
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
unclear
|
Study aim
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Prevention
|
Inclusion criteria
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. Healthy individuals above 18 years of age
2. Have never been infected with SARS-CoV-2
3. Have never been vaccinated with COVID-19 vaccine
4. Not in the immunocompromised status
|
Exclusion criteria
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. Are being infected with COVID-19
2. Bleeding disorders
|
Number of arms
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2
|
Funding
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
National Research Council of Thailand (NRCT)
|
Inclusion age min
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
18
|
Inclusion age max
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
100
|
Countries
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Thailand
|
Type of patients
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Healthy volunteers
|
Severity scale
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
N/A
|
Total sample size
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
100
|
primary outcome
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
immunogenicity 1 month post two doses anti-spike RBD IgG
|
Notes
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
|
Phase
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Phase 3
|
Arms
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "heterologous prime/boost;1+1;ChAdOx0-1 first and CoronaVac second", "treatment_id": 1444, "treatment_name": "Chadox1 ncov-19+coronavac", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "heterologous prime/boost;1+1;CoronaVac first and ChAdOx0-1 second", "treatment_id": 1444, "treatment_name": "Chadox1 ncov-19+coronavac", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}]
|