A Phase 2 interventional study of Cepharanthine and Placebo in Asymptomatic COVID-19, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 2 sites in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 450 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
Drug: cepharanthine (tablet) Day 1\~5: 20mg, Q8H X 5 days + standardized medical treatment
Drug: Cepharanthine
Drug: cepharanthine (tablet) Day 1\~5: 40mg, Q8H X 5 days + standardized medical treatment
Drug: Cepharanthine
Drug: cepharanthine placebo (tablet) Day 1\~5: placebo + standardized medical treatment
Drug: Placebo
Low-dose: Day 1\~5: 20mg, Q8H X 5 days (60mg/day)+SMT
Also known as: Low- dose Cepharanthine (tablet)
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.
Also known as: Placebo (tablet)
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.
Also known as: High- dose Cepharanthine (tablet)
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)
Time frame: 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.
Time frame: Day 1 through Day 28
Proportion of participants developing COVID-19 pneumonia
Time frame: Day 1 through Day 28
Proportion of participants developing severe pneumonia
Time frame: Day 1 through Day 28
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of CEP relative to placebo.
Time frame: Day 1 through Day 28
Number of days from the onset of fever until the temperature drops below 37.3°C
Time frame: Day 1 through Day 28
Plan to share: Undecided — If shared, including protocol, case report form (CRF), Statistical Analysis Plan (SAP), etc.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine