| Trial registration number
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NCT05642910 |
Full text link
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05642910
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First author
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Songqiao Liu, MD. PhD.
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Contact
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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liusongqiao@ymail.com
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Registration date
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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2022-12-08
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Recruitment status
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
patients aged 18-85 years (inclusive).
meet the diagnostic criteria for covid-19.
at least one high risk factor for progression to severe covid-19
no more than 5 days from the onset of clinical symptoms
sign informed consent form.
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Exclusion criteria
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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severe or critically patients with covid-19
have received neutralizing antibodies or convalescent plasma therapy due to covid-19
child-pugh grade c or acute liver failure
chronic renal failure (egfr<30 ml/min)
grade iii or iv cardiac function, or known left ventricular ejection fraction < 30%
known or suspected history of active or extrapulmonary tuberculosis
patients who are allergic to the active ingredient of the drug
pregnant and lactating women
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Number of arms
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Southeast University, China
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Inclusion age min
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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85
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Countries
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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China
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Type of patients
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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High risk patients
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Severity scale
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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540
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primary outcome
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
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Notes
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Dec. 11, 2022, 4 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "nan", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 167, "treatment_name": "Azvudine", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]
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