NCT05398705

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

An Interventional Efficacy and Safety, Phase 2, Double-blind, 3-arm Study to Investigate Orally Administered High/Low-dose Cepharanthine Compared With Placebo in Nonhospitalized Asymptomatic or Mild Adult Participants With COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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 who do not need to be in the hospital, but in alternate care site.

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 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

• Asymptomatic COVID-19

Interventions

Type	Name	Description
DRUG	Cepharanthine	Low-dose: Day 1\~5: 20mg, Q8H X 5 days (60mg/day)+SMT
DRUG	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.
DRUG	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.

Timeline

• Start date: 2022-05-31
• Primary completion: 2022-08-10
• Completion: 2022-08-10
• First posted: 2022-06-01
• Last updated: 2022-08-25

Locations

2 sites across 1 country: China