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| Name | Class |
|---|---|
| Yunnan Baiyao Group Co., Ltd. | INDUSTRY |
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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 who do not need to be in the hospital, but in alternate care site.
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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose cepharanthine + standardized medical treatment | Experimental | Drug: cepharanthine (tablet) Day 1~5: 20mg, Q8H X 5 days + standardized medical treatment |
|
| High-dose cepharanthine + standardized medical treatment | Experimental | Drug: cepharanthine (tablet) Day 1~5: 40mg, Q8H X 5 days + standardized medical treatment |
|
| placebo+standardized medical treatment | Placebo Comparator | Drug: cepharanthine placebo (tablet) Day 1~5: placebo + standardized medical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cepharanthine | Drug | Low-dose: Day 1~5: 20mg, Q8H X 5 days (60mg/day)+SMT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants developing COVID-19 pneumonia | Day 1 through Day 28 | |
| Proportion of participants developing severe pneumonia | Day 1 through Day 28 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hai Li, MD | Department of gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine | Shanghai | Shanghai Municipality | 200000 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35579892 | Result | 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. | |
| 35172054 |
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If shared, including protocol, case report form (CRF), Statistical Analysis Plan (SAP), etc.
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| ID | Term |
|---|---|
| C006947 | cepharanthine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Eligible participants with a confirmed diagnosis of SARS-CoV-2 infection in alternate care site will be randomized (1:1:1) to receive low-dose cepharanthine, high-dose cepharanthine or placebo orally every 8 hours for 5 days.
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| Placebo | Drug | 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 | Drug | 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. |
|
|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of CEP relative to placebo. |
| Day 1 through Day 28 |
| Number of days from the onset of fever until the temperature drops below 37.3°C | Day 1 through Day 28 |
| Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity |
| Shanghai |
| Shanghai Municipality |
| China |
| 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. |
| 39890847 | Derived | 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. |