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Trial - TCTR20210906005


Column Value
Trial registration number TCTR20210906005
Full text link
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Porpon Rotjanapan

Contact
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

porpon.rot@mahidol.ac.th

Registration date
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-09-06

Recruitment status
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Aged 18 years and over 2. Diagnosed with COVID-19 pneumonia 3. Agrees to participate in the study

Exclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Individuals with gastrointestinal disorders that are unable to take oral medications 2. Diagnosed with sarcoidosis within 1 year 3. Diagnosed with parathyroid gland disease within 1 year 4. Diagnosed with tuberculosis within 1 year 5. Diagnosed with kidney calculi within 1 year 6. Concurrent hypercalcemia with plasma calcium level over 10.6 mg/dL 7. Pregnant or breastfeeding individuals 8. Decline to participate in the study 9. Receipt of palliative therapy

Number of arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Faculty of Medicine Ramathibodi Hospital; Mahidol University

Inclusion age min
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Thailand

Type of patients
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

400

primary outcome
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

COVID-19 pneumonia 30 days Modified ordinal scale

Notes
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 2

Arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "high dose", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]