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Asymptomatic COVID-19Phase 2NCT05398705

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

A Phase 2 study testing Cepharanthine in people with Asymptomatic COVID-19, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Asymptomatic COVID-19
What is being tested?
Cepharanthine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
2 sitesChina
Study dates
31 May 2022to 10 Aug 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Cepharanthine, Placebo
Keywords
Asymptomatic COVID-19, cepharanthine, adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CepharanthineDrug

    Also called Low- dose Cepharanthine (tablet)

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

  • PlaceboDrug

    Also called Placebo (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.

  • CepharanthineDrug

    Also called High- dose Cepharanthine (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.

Study groups in NCT05398705
Study groupRoleWhat they receive
Low-dose cepharanthine + standardized medical treatmentExperimentalDrug: cepharanthine (tablet) Day 1~5: 20mg, Q8H X 5 days + standardized medical treatment
Receives: Drug: Cepharanthine
High-dose cepharanthine + standardized medical treatmentExperimentalDrug: cepharanthine (tablet) Day 1~5: 40mg, Q8H X 5 days + standardized medical treatment
Receives: Drug: Cepharanthine
placebo+standardized medical treatmentPlacebo comparatorDrug: cepharanthine placebo (tablet) Day 1~5: placebo + standardized medical treatment
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 1 through Day 28

  2. 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.

    Measured: Day 1 through Day 28

Secondary outcomes (4)

  1. Proportion of participants developing COVID-19 pneumonia

    Measured: Day 1 through Day 28

  2. Proportion of participants developing severe pneumonia

    Measured: Day 1 through Day 28

  3. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of CEP relative to placebo.

    Measured: Day 1 through Day 28

  4. Number of days from the onset of fever until the temperature drops below 37.3°C

    Measured: Day 1 through Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2022
  2. Study start31 May 2022
  3. Primary completion10 Aug 2022
  4. Study completion10 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05398705
Sponsor's protocol ID
CEP-Omicron
Status last verified
Aug 2022
First submitted
29 May 2022
Last updated
25 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If shared, including protocol, case report form (CRF), Statistical Analysis Plan (SAP), etc.

Publications

  • 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.

    PubMed 35579892

  • 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.

    PubMed 35172054

  • 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.

    PubMed 39890847

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cepharanthine in people with Asymptomatic COVID-19, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to viral clearance (time frame: Day 1 through Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05398705, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.

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