Clinical trial NCT05398705: Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asymptomatic COVID-19
Keywords: Asymptomatic COVID-19
cepharanthine
adult
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: YUNNAN BAIYAO GROUP CO.,LTD
First posted: 2022-06-01
Enrollment: 450
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to viral clearance
timeFrame: Day 1 through Day 28
measure: SARS-CoV-2 viral load
timeFrame: Day 1 through Day 28
Secondary outcomes:
measure: Proportion of participants developing COVID-19 pneumonia
timeFrame: Day 1 through Day 28
measure: Proportion of participants developing severe pneumonia
timeFrame: Day 1 through Day 28
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of CEP relative to placebo.
timeFrame: Day 1 through Day 28
measure: Number of days from the onset of fever until the temperature drops below 37.3°C
timeFrame: Day 1 through Day 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity
state: Shanghai
Study officials:
affiliation: Department of gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine
name: Hai Li, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.