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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 |
|
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"}] |