Trial registration number
|
NCT04657497 |
Full text link
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04657497
|
First author
Last imported at : June 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
|
Ono Pharmaceutical Co. Ltd Medicine counseling department
|
Contact
Last imported at : June 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
|
clinical_trial@ono.co.jp
|
Registration date
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
2020-12-08
|
Recruitment status
Last imported at : June 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
|
Completed
|
Study design
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
Blind label
|
Center
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
multi-center
|
Study aim
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
inpatient or outpatient: inpatient
positive sars-cov-2 test by a method eligible for definitive diagnosis
enrollment in this study within 5 days after onset of symptoms of sars-cov-2 infection (covid-19) (for asymptomatic patients, enrollment in this study within 5 days after collection of the sample that tested positive)
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
receiving oxygen therapy
difficulty in swallowing oral medication
history of covid-19
history of vaccination against covid-19
taking camostat mesilate
|
Number of arms
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
Ono Pharmaceutical Co. Ltd
|
Inclusion age min
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
100
|
Countries
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
Japan
|
Type of patients
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
Mild disease at enrollment
|
Severity scale
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
1: Mild disease at enrollment
|
Total sample size
Last imported at : June 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
|
155
|
primary outcome
Last imported at : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
Time to SARS-CoV-2 negative test
|
Notes
Last imported at : Dec. 10, 2020, 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 : Dec. 10, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]
|