Clinical TrialID 7362

Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19

NCT05398705

Asymptomatic COVID-19

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Record Fields

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Clinical Trial Id
7362
Evidence Id
7362
Core Evidence Id
7362
Source Clinical Trial Id
7356
Herb2 Clinical Trial Id
HBCT007356
Nct Id
NCT05398705
Title
Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19
Status
Completed
Phase
Phase 2
Study Result
No
Study Condition
Asymptomatic COVID-19
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Cepharanthine|DRUG: Placebo|DRUG: Cepharanthine
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Child, Adult, Older_Adult
Enrollment
450
Outcome Measure
Time to viral clearance, The time to viral clearance was defined as first positive nucleic acid test(or randomization) to the date of the first negative test (in two consecutive point), Day 1 through Day 28|SARS-CoV-2 viral load, SARS-CoV-2 viral load was detected and quantified by RT-PCR using nasopharyngeal swabs . Ct value\>35 for both ORF1ab and N gene was considered as negativity., Day 1 through Day 28
Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine|YUNNAN BAIYAO GROUP CO.,LTD
Funded By
OTHER
Location
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, Shanghai, 200000, China|Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity, Shanghai, Shanghai, China
Other Id
CEP-Omicron
Start Date
2022-05-31
Primary Completion Date
2022-08-10
Completion Date
2022-08-10
First Posted
2022-06-01
Results First Posted
Last Update Posted
2022-08-25
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05398705
Title Cn
Title En
Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19
Bilingual Status
semi_complete