Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19
NCT ID: NCT05398705
Last Updated: 2022-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
450 participants
INTERVENTIONAL
2022-05-31
2022-08-10
Brief Summary
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Detailed Description
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Patients will be randomized to one of three arms, all participants will receive standardized medical treatment (SMT) according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and Chinese traditional medicine, etc.
* low-dose experimental arm：cepharanthine 60mg/day + SMT
* high-dose experimental arm：cepharanthine 120mg/day + SMT
* placebo control arm：placebo + SMT
The primary outcome measure is the time to viral clearance which defined as first positive nucleic acid test to the date of the first negative test (in two consecutive point). 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low-dose cepharanthine + standardized medical treatment
Drug: cepharanthine (tablet) Day 1\~5: 20mg, Q8H X 5 days + standardized medical treatment
Cepharanthine
Low-dose: Day 1\~5: 20mg, Q8H X 5 days (60mg/day)+SMT
High-dose cepharanthine + standardized medical treatment
Drug: cepharanthine (tablet) Day 1\~5: 40mg, Q8H X 5 days + standardized medical treatment
Cepharanthine
High-dose: Day 1\~5: 40mg, Q8H X 5 days (120mg/day) +SMT
SMT:standardized medical treatment according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and Chinese traditional medicine, etc.
placebo+standardized medical treatment
Drug: cepharanthine placebo (tablet) Day 1\~5: placebo + standardized medical treatment
Placebo
Day 1\~5: placebo+SMT
SMT:standardized medical treatment according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor, antiviral drug and Chinese medicine treatment, etc.
Interventions
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Cepharanthine
Low-dose: Day 1\~5: 20mg, Q8H X 5 days (60mg/day)+SMT
Placebo
Day 1\~5: placebo+SMT
SMT:standardized medical treatment according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor, antiviral drug and Chinese medicine treatment, etc.
Cepharanthine
High-dose: Day 1\~5: 40mg, Q8H X 5 days (120mg/day) +SMT
SMT:standardized medical treatment according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and Chinese traditional medicine, etc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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YUNNAN BAIYAO GROUP CO.,LTD
UNKNOWN
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Hai Li
professor of department of gastroenterological division, Renji Hospital
Principal Investigators
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Hai Li, MD
Role: STUDY_DIRECTOR
Department of gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine
Locations
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Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China
Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity
Shanghai, Shanghai Municipality, China
Countries
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References
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Shen Y, Ai J, Lin N, Zhang H, Li Y, Wang H, Wang S, Wang Z, Li T, Sun F, Fan Z, Li L, Lu Y, Meng X, Xiao H, Hu H, Ling Y, Li F, Li H, Xi C, Gu L, Zhang W, Fan X. An open, prospective cohort study of VV116 in Chinese participants infected with SARS-CoV-2 omicron variants. Emerg Microbes Infect. 2022 Dec;11(1):1518-1523. doi: 10.1080/22221751.2022.2078230.
Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.
Wei J, Liu S, Bian Y, Li L, Qian B, Shen Z, Zhang Y, Abuduaini A, Dong F, Zhang X, Li J, Yu Y, Zhang W, Wang J, Zhai W, Song Q, Zheng Y, Pan W, Yu L, Zhan Q, Zhang N, Zheng J, Pan S, Yao C, Li H. Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial : Author detials. Sci Rep. 2025 Jan 31;15(1):3875. doi: 10.1038/s41598-024-75891-3.
Other Identifiers
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CEP-Omicron
Identifier Type: -
Identifier Source: org_study_id
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