Asymptomatic COVID-19
Conditions
Keywords
Asymptomatic COVID-19, cepharanthine, adult
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.
Interventions
DRUGCepharanthine
Low-dose: Day 1\ 5: 20mg, Q8H X 5 days (60mg/day)+SMT
DRUGPlacebo
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.
Sponsors
YUNNAN BAIYAO GROUP CO.,LTD
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to viral clearance | 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) |
| SARS-CoV-2 viral load | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed