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| Column | Value |
|---|---|
| Trial registration number | NCT04261270 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
qning@vip.sina.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-02-07 |
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Recruitment status
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: age:18~55 years old, unlimited gender. laboratory (rt-pcr) confirmed infection with 2019-ncov and accompanied with clinical manifestations. patients with newly diagnosed respiratory discomfort who have been hospitalized (the proper diagnosis time is less than 7 days). women who have no planned pregnancy in the next six months,and are willing to take effective measures to prevent contraception from the first dose of study drug to 30 days after the last dose. agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose. patients who voluntarily sign informed consent forms. |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
1.2019-ncov severe pneumonia patients. meet the definition of severe pneumonia(comply with any of the followings): respiratory distress ,rr≥30 bpm; in a resting state:spo2≤93%; pao2/ fio2≤300mmhg. 2.2019-ncov critical and severe pneumonia patients.comply with any of the followings:respiratory failure and need mechanical ventilation;shock;patients combined with other organ failure need icu monitoring and treatment. 3.severe liver disease(such as:the childpugh score≥c;ast > 5 times the upper limit). 4.patients who are allergic to the ingredients of asc09/ritonavir compound tablets. 5.patients with definite contraindications in ritonavir tablets. 6.female subjects were positive for the pregnancy test during the screening period. 7.researcher judges unsuitable for participation in this clinical trial(such as:during the study patients may be transferred to hospital for treatment;patients with multiple underlying diseases, etc) |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Tongji Hospital |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
55 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
60 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Rate of comprehensive adverse outcome |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1413, "treatment_name": "Asc09+oseltamivir", "treatment_type": "Anti-inflammatories+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1696, "treatment_name": "Oseltamivir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 937, "treatment_name": "Oseltamivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}] |