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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Asymptomatic COVID-19

Treatments: Drug: Placebo; Drug: Cepharanthine

Study type: Interventional

Funder types: Other

Identifiers

NCT05398705

CEP-Omicron

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 3 patient groups, including a placebo group

Low-dose cepharanthine + standardized medical treatment

Experimental group

Description:

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

Treatment:

Drug: Cepharanthine

Drug: Cepharanthine

High-dose cepharanthine + standardized medical treatment

Experimental group

Description:

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

Treatment:

Drug: Cepharanthine

Drug: Cepharanthine

placebo+standardized medical treatment

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo