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

August 22, 2022 updated by: Hai Li, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China
        • Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose cepharanthine + standardized medical treatment
Drug: cepharanthine (tablet) Day 1~5: 20mg, Q8H X 5 days + standardized medical treatment
Drug: Cepharanthine
Low-dose: Day 1~5: 20mg, Q8H X 5 days (60mg/day)+SMT
Other Names:
  • Low- dose Cepharanthine (tablet)
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.

Other Names:
  • High- dose Cepharanthine (tablet)
Experimental: High-dose cepharanthine + standardized medical treatment
Drug: cepharanthine (tablet) Day 1~5: 40mg, Q8H X 5 days + standardized medical treatment
Drug: Cepharanthine
Low-dose: Day 1~5: 20mg, Q8H X 5 days (60mg/day)+SMT
Other Names:
  • Low- dose Cepharanthine (tablet)
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.

Other Names:
  • High- dose Cepharanthine (tablet)
Placebo Comparator: placebo+standardized medical treatment
Drug: cepharanthine placebo (tablet) Day 1~5: placebo + standardized medical treatment
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.

Other Names:
  • Placebo (tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to viral clearance
Time Frame: Day 1 through Day 28
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
Time Frame: Day 1 through Day 28
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants developing COVID-19 pneumonia
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Proportion of participants developing severe pneumonia
Time Frame: Day 1 through Day 28
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
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
Day 1 through Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

YUNNAN BAIYAO GROUP CO.,LTD

Investigators

  • Study Director: Hai Li, MD, Department of gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Actual)

August 10, 2022

Study Completion (Actual)

August 10, 2022

Study Registration Dates

First Submitted

May 29, 2022

First Submitted That Met QC Criteria

May 29, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP-Omicron

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If shared, including protocol, case report form (CRF), Statistical Analysis Plan (SAP), etc.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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