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Trial - NCT05398705


Column Value
Trial registration number NCT05398705
Full text link
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Aug. 23, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Hai Li

Contact
Last imported at : Aug. 23, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

2022-06-01

Recruitment status
Last imported at : Aug. 23, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : July 16, 2022, 3 a.m.
Source : ClinicalTrials.gov

inclusion criteria: aged over 16 years old with all genders sars-cov-2 positive(laboratory-confirmed reverse transcription polymerase chain reaction (rt pcr) test) patient or immediate adult family member agrees to participate in this study and signs an informed consent form asymptomatic or patients with mild covid-19 symptoms confirmed sars-cov-2 infection within 5 days prior to randomization

Exclusion criteria
Last imported at : June 21, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

confirmed sars-cov-2 infection within > 5 days prior to randomization ct shows pneumonia on admission diagnosed as severe or critical covid-19 before intervention has a history of chronic underlying disease and acute exacerbation of that underlying disease at the time of admission females who are pregnant or breastfeeding

Number of arms
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : June 21, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

Shanghai Jiao Tong University School of Medicine

Inclusion age min
Last imported at : June 21, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

16

Inclusion age max
Last imported at : June 21, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : June 21, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Aug. 23, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

450

primary outcome
Last imported at : June 21, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

SARS-CoV-2 viral load;Time to viral clearance

Notes
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "low dose", "treatment_id": 2511, "treatment_name": "Cepharanthine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "high dose", "treatment_id": 2511, "treatment_name": "Cepharanthine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]