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Trial - TCTR20210628005


Column Value
Trial registration number TCTR20210628005
Full text link
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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"}]