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Trial - TCTR20220302001


Column Value
Trial registration number TCTR20220302001
Full text link
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Chaicharn Pothirat

Contact
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

chaicharn.p@cmu.ac.th

Registration date
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2022-03-02

Recruitment status
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Inpatients diagnosed with mild to moderated COVID-19 pneumonia (Infiltration in CXR and oxygen saturation (SpO2) equal or greater than 94% on room air. The CXR will be written by pulmonologists and/or radiologists at the first day of admission or the first day of perform CXR. 2. aged equal or greater than 18 years old

Exclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. COPD and asthma treated with ICS in the past 4 week 2. had recent use (within 7 days) of inhaled or systemic glucocorticoids 3. had a known allergy or contraindication to inhaled budesonide 4. subjects who have participated in the other clinical trial

Number of arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Faculty of Medicine; Chiang Mai University

Inclusion age min
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Thailand

Type of patients
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild/moderate disease at enrollment

Severity scale
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

76

primary outcome
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Severe pneumonia event 1 time measured at the day of discharge or patient turn to severe pneumonia Number of case with severe pneumonia

Notes
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 3

Arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 242, "treatment_name": "Budesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]