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Trial - TCTR20211228003


Column Value
Trial registration number TCTR20211228003
Full text link
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Kriangkrai Tawinprai

Contact
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

kriangkrai.taw@pccms.ac.th

Registration date
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-12-28

Recruitment status
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

nonRCT

Allocation
Last imported at : April 1, 2022, 1 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Non-randomized

Design
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Single group assignment

Masking
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. age more than 18 years old 2. Anti-SAR-CoV-2 negative 3. diabetes mellitus or 4. cirrhosis or 5. solid cancer or 6. hematologic malignancy or 7. chronic kidney disease (GFR &lt,60 ml/mi/1.73 m2) 8. rheumatological disease or 9. cardiovascular disease

Exclusion criteria
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. previous covid-19 vaccination 2. prior other vaccine in 14 days 3. pregnancy 4. lactation

Number of arms
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1

Funding
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Chulabhorn Royal Academy

Inclusion age min
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Thailand

Type of patients
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

High risk patients

Severity scale
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

420

primary outcome
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

The change of geometric mean titer levels to RBD of spike protein compare 28 days and 180 days after 2 nd dose vaccination anti-Sar-Cov2

Notes
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 4

Arms
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "2;Days0-84;IM", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]