Covid19
Conditions
Keywords
antiviral, SARS-CoV-2, COVID19
Brief summary
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
Interventions
BIOLOGICALNovaferon
a novel recombinant antiviral protein drug
BIOLOGICALPlacebo
Saline
Sponsors
Genova Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent has been obtained from the participants with age of over 20 years at the time of signing the informed consent. * SARS-CoV-2 infection is diagnosed by the positive SARS-CoV-2 detection of RT-PCR tests within 72 hours before the start of administration of the investigational drug * Less than 6 days from onset of COVID-19 symptoms to starting the administration of the investigational drug. The symptoms are defined as one or more of the following: fever (37.5 ºC or higher), respiratory symptoms (cough, shortness of breath, chest pain, sore throat, running nose, nasal congestion, etc.), headache, malaise, abdominal pain, diarrhea, nausea, vomiting, loss of smell, loss of taste, or other COVID-19 symptoms defined by investigators or physicians. * Have at least one of the following findings. * Oxygen saturation (SpO2) measured by pulse oximeter is less than 96% and more than 93%. * Chest X-ray or CT scan shows pneumonia findings suggestive of COVID-19 infection * Need hospitalization and COVID-19-related medical care. * Require no supplemental oxygen. * Women (less than 12 months after the last menstrual period) who have a negative pregnancy test (urine hCG qualification) and agree to take oral contraceptives or use condom during study period.
Exclusion criteria
* History of hypersensitivity to interferon or Novaferon or any excipients of interferon or Novaferon. * Having received other antiviral treatments (Favipiravir, Remdesivir, Interferon, etc.). * CTCAE Grade 3 or higher liver dysfunction (ALT / AST\> 5ULN) or renal dysfunction (eGFR \<30 mL / min / 1.73 m2). * Active infections or other medical conditions that contraindicate inhalation therapy. * Inappropriate for inclusion in the clinical trial as determined by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical improvement | From enrollment up to Day 28 | Time to patient clinical improvement by 2 points on a 7-point ordinal scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical improvement | Day 1 to Day 10, 14 and 28 | Rate at which patients show a clinical improvement by 2 points on a 7-point ordinal scale |
| Rate of clinical deterioration | Day 1 to Day 10, 14 and 28 | Rate at which patients show a clinical deterioration by 2 points on a 7-point ordinal scale |
| Time to viral clearance | From enrollment up to Day 28 | Time taken for patients to demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs |
| Rate of viral clearance | Each Day from Day 1 up to Day 28 | The rate at which patients demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs |
| Change in viral load | Each Day from Day 1 up to Day 28 | Changes of SARS-CoV-2 viral loads in the samples of nasopharyngeal swabs |
| Mortality rate | At Day 28 | Mortality rate |
| Duration of hospital stay | From enrollment up to Day 28 | Number of days the patient is in hospital |
| Time to resolution of symptoms | From enrollment up to Day 28 | Time taken for patients to demonstrate a resolution of symptoms defined as a (National Early Warning Score 2) NEWS 2 of 0 maintained for 24hours |
| Requirement of supplemental oxygen | From enrollment up to Day 28 | Rate at which patients require supplemental oxygen |
| Requirement of mechanical ventilation | From enrollment up to Day 28 | Rate at which patients require mechanical ventilation (invasive or non-invasive) |
| Rate of alive patients | At Day 28 | Rate of patients alive without having to use invasive ventilator or ECMO |
| Adverse events | From enrollment up to Day 28 | Adverse event incidence, type and severity |
Countries
Japan
Contacts
Primary ContactHuimei Huang
Backup ContactHaifeng Jin
Outcome results
None listed