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| Column | Value |
|---|---|
| Trial registration number | NCT05682599 |
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Full text link
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
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First author
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
hsmqchen@gmail.com |
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Registration date
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
2023-01-12 |
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Recruitment status
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 13, 2023, noon 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 : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: 1、18-65 years old at the signing of informed consent. 2、household contacts of individual with symptomatic covid-19. symptomatic covid-19 cases (index case) to be identified as those symptomatic and recently tested (rapid antigen test or rt-pcr) positive for sars-cov-2 and must fulfill the following criteria 1) collection of the first positive sars-cov-2 test sample less than 24 hours before randomization, 2) have at least one symptom attributable to covid-19. 3、rt-pcr test negative (with nasopharyngeal [np] swab samples) or rapid antigen test negative at the time of screening and without any suspicious covid-19 symptoms within 2 weeks before randomization. 4、subject expects to be living in the same household with the symptomatic covid-19 cases during the whole study period. |
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Exclusion criteria
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
subject with a history of sars-cov-2 vaccinations within 1 months before randomization. subject with a history of sars-cov-2 infection within 6 months before randomization. with any serious infection requiring systemic anti-infective therapy within 14 days before randomization. allergic to the investigational agent or any components of the formulation. pregnant or breast-feeding women. women of childbearing potential who are unwilling to practice highly effective contraception during the study, and for at least 6 months after the study; sexually active men who are unwilling to use medically acceptable birth control during the study period. have other conditions not suitable for inclusion as judged by the investigator. |
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Number of arms
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Shanghai Henlius Biotech |
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Inclusion age min
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
65 |
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Countries
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
300 |
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primary outcome
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Efficacy-Incidence of SARS-CoV-2 infection in 8 days |
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Notes
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
[{"arm_notes": "6 mg", "treatment_id": 167, "treatment_name": "Azvudine", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "3 mg", "treatment_id": 167, "treatment_name": "Azvudine", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |