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Trial - NCT04891302


Column Value
Trial registration number NCT04891302
Full text link
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04891302

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

Not reported

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

Not reported

Registration date
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-05-18

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

Completed

Study design
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : May 19, 2021, 12:31 a.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, and hospitalized patients who experienced first symptom related to covid-19 within 7days prior to enrollment and confirmed 2 or more relative symptoms at the time of randomization. patients with peripheral capillary oxygen saturation(spo2) greater than 94% at the time of screening, who do not need supplemental oxygen therapy. key

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

patients who participated in other clinical trials related to covid-19 patients who were administered drugs directly to covid-19 24hours prior to the start of the study. patients who need oxygen supply or breathing device (non-invasive mechanical ventilation(via mask)), mechanical ventilator requirement (via endotracheal tube or tracheostomy tube, ecmo requirement) at the time of screening or baseline patients whose ast or alt has increased by more than 5 times the normal lab value.

Number of arms
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Bukwang Pharmaceutical

Inclusion age min
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

19

Inclusion age max
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Korea;Republic of

Type of patients
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

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

104

primary outcome
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.

Notes
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : May 19, 2021, 12:31 a.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"}]