Status:
COMPLETED
Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
YUNNAN BAIYAO GROUP CO.,LTD
Conditions:
Asymptomatic COVID-19
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of high/low-dose cepharanthine for the Treatment of COVID-19 in asymptomatic and non-pneumonia mild adult participants with COVID-19 wh...
Detailed Description
Screening participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures. Patients will be randomized to one of three arms, all participants will recei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2022
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05398705
Start Date
May 31 2022
End Date
August 10 2022
Last Update
August 25 2022
Active Locations (2)
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1
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China, 200000
2
Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity
Shanghai, Shanghai Municipality, China