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Trial - NCT04347915


Column Value
Trial registration number NCT04347915
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Woo-Joo Kim

Contact
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-15

Recruitment status
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

key inclusion criteria: over 19 years of age covid-19 confirmed by a real-time rt-pcr tests 4 days prior to clinical trial enrollment patients with peripheral capillary oxygen saturation (spo2) greater than 94% at the time of screening patients whose body temperature is measured according to the measured area without taking a fever reducer during screening: [armpit of greater than 37.0 °c or an oral of greater than 37.2 °c; patients with rectum greater than 37.6 °c or eardrum greater than 37.5 °c] (notes: although you take a fever reducer, you can still be enrolled in after investigator's judgement whether there is fever or not.) patients with evidence of lung invasions as a result of radiation tests

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

patients who need breathing device (for example, invasive ventilation, invasive mechanical ventilation, extra-corporeal membrane oxygenation). patients who participated in other clinical trials related to covid-19. patients who were administered drugs directly to covid-19 24 hours prior to the start of the study. patients whose ast or alt has increased by more than 5 times the normal lab value.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Bukwang Pharmaceutical

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

19

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Korea;Republic of

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

64

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 295, "treatment_name": "Clevudine", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]