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Trial - NCT04713176


Column Value
Trial registration number NCT04713176
Full text link
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-19

Recruitment status
Last imported at : Oct. 2, 2023, 10:07 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 20, 2021, 12:31 a.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 : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - adults over the age of 19 as of the signed date in written consent - subjects with covid-19 according to rt-pcr test(within 10 days) - subjects who need to be hospitalized and injected remdesivir

Exclusion criteria
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- subjects who cannot orally administer the investigational products - subjects who requiring mechanical ventilation or ecmo - acute respiratory distress syndrome(ards), shock, multiple organ dysfunction syndrome - subjects who need administration of immunosuppressants - subjects who are allergic or sensitive to investigational products or its ingredients - crcl < 30 ml/min or egfr < 30 ml/min/1.73m^2 - ast or alt >= 5xuln - subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators

Number of arms
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Daewoong Pharmaceutical Co. LTD.

Inclusion age min
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

19

Inclusion age max
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Korea;Republic of

Type of patients
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 2, 2023, 10:07 a.m.
Source : ClinicalTrials.gov

240

primary outcome
Last imported at : Oct. 2, 2023, 10:07 a.m.
Source : ClinicalTrials.gov

Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days

Notes
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 3

Arms
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1681, "treatment_name": "Camostat mesilate+remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]