NCT05398705

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

May 29, 2022

Last Update Submit

August 22, 2022

Conditions

Asymptomatic COVID-19

Keywords

Asymptomatic COVID-19cepharanthineadult

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Proportion of participants developing COVID-19 pneumonia

    Day 1 through Day 28

  • Proportion of participants developing severe pneumonia

    Day 1 through Day 28

  • 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

Study Arms (3)

Low-dose cepharanthine + standardized medical treatment

EXPERIMENTAL

Drug: cepharanthine (tablet) Day 1\~5: 20mg, Q8H X 5 days + standardized medical treatment

Drug: Cepharanthine

High-dose cepharanthine + standardized medical treatment

EXPERIMENTAL

Drug: cepharanthine (tablet) Day 1\~5: 40mg, Q8H X 5 days + standardized medical treatment

Drug: Cepharanthine

placebo+standardized medical treatment

PLACEBO COMPARATOR

Drug: cepharanthine placebo (tablet) Day 1\~5: placebo + standardized medical treatment

Drug: Placebo

Interventions

CepharanthineDRUG

Low-dose: Day 1\~5: 20mg, Q8H X 5 days (60mg/day)+SMT

Also known as: Low- dose Cepharanthine (tablet)
Low-dose cepharanthine + standardized medical treatment
PlaceboDRUG

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)
placebo+standardized medical treatment

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity

Shanghai, Shanghai Municipality, China

Location

Related Publications (3)

  • 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.

    PMID: 35579892RESULT

  • 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.

    PMID: 35172054RESULT

  • 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.

    PMID: 39890847DERIVED

MeSH Terms

Interventions

cepharanthineTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Hai Li, MD

    Department of gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of department of gastroenterological division, Renji Hospital

Study Record Dates

First Submitted

May 29, 2022

First Posted

June 1, 2022

Study Start

May 31, 2022

Primary Completion

August 10, 2022

Study Completion

August 10, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

CN(2)