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| Column | Value |
|---|---|
| Trial registration number | NCT04252885 |
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Full text link
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Yueping Li, lipipi007@163.com (PI email not reported) |
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Registration date
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2020-02-05 |
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Recruitment status
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - in sputum, throat swab, lower respiratory tract secretion, blood and other samples, the nucleic acid of the novel coronavirus was positive, or the sequencing of the virus gene was highly homologous with the known novel coronavirus - age is between 18-80 years old, the weight is more than 30kg, and there is no limit for men and women - the following conditions were met: creatinine ≤ 110 umol / l, creatinine clearance rate (egfr) ≥ 60 ml / min / 1.73m2, ast and alt ≤ 5 × uln, tbil ≤ 2 × uln; - the subjects should fully understand the purpose, nature, method and possible reaction of the study, voluntarily participate in the study and sign the informed consent. |
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Exclusion criteria
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- have a clear history of lopinavir or ritonavir or arbidol allergy - severe nausea, vomiting, diarrhea and other clinical manifestations affect the oral or absorption of the drugs - at the same time, take drugs that may interact with lopinavir or ritonavir or arbidol - patients with serious underlying diseases, including but not limited to heart disease (including history of angina pectoris or coronary heart disease or myocardial infarction, atrioventricular block), lung, kidney, liver malfunction and mental diseases that cannot be treated together - ancreatitis or hemophilia - pregnant and lactating women - suspected or confirmed history of alcohol and drug abuse - participated in other drug trials in the past month - the researchers judged that patients were not suitable for the study |
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Number of arms
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Guangzhou 8th People's Hospital |
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Inclusion age min
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
80 |
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Countries
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
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Severity scale
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
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Total sample size
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
86 |
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primary outcome
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
The rate of virus inhibition |
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Notes
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |