Clinical trial NCT04708158: Novaferon for COVID-19 Treatment Trial (NCTT-005)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon vs. Placebo in Hospitalized Adult Patients With ModerateCOVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid19
Keywords: antiviral
SARS-CoV-2
COVID19
Lead sponsor: Genova Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 385
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients


Eligibility criteria: 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.

Primary outcomes:
measure: Time to clinical improvement
timeFrame: From enrollment up to Day 28
Secondary outcomes:
measure: Rate of clinical improvement
timeFrame: Day 1 to Day 10, 14 and 28
measure: Rate of clinical deterioration
timeFrame: Day 1 to Day 10, 14 and 28
measure: Time to viral clearance
timeFrame: From enrollment up to Day 28
measure: Rate of viral clearance
timeFrame: Each Day from Day 1 up to Day 28
measure: Change in viral load
timeFrame: Each Day from Day 1 up to Day 28
measure: Mortality rate
timeFrame: At Day 28
measure: Duration of hospital stay
timeFrame: From enrollment up to Day 28
measure: Time to resolution of symptoms
timeFrame: From enrollment up to Day 28
measure: Requirement of supplemental oxygen
timeFrame: From enrollment up to Day 28
measure: Requirement of mechanical ventilation
timeFrame: From enrollment up to Day 28
measure: Rate of alive patients
timeFrame: At Day 28
measure: Adverse events
timeFrame: From enrollment up to Day 28
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba Aoba Municipal Hospital
city: Chiba
country: Japan
facility: Kamagaya General Hospital
city: Chiba
country: Japan
facility: NHO Chiba Medical Center
city: Fukuoka
country: Japan
facility: NHO Omuta National Hospital
city: Ibaraki
country: Japan
facility: NHO Kasumigaura Medical Center
city: Ibaraki
country: Japan
facility: Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital
city: Kanagawa
country: Japan
facility: Kokankai Nippon Kokan Hospital
city: Kyoto
country: Japan
facility: Rakuwakai Otowa Hospital
city: Okayama
country: Japan
facility: Okayama City General Medical Center Okayama City Hospital
city: Osaka
country: Japan
facility: Osaka Habikino Medical Center
city: Osaka
country: Japan
facility: Rinku General Medical Center
city: Osaka
country: Japan
facility: Sakai City Medical Center
city: Shiga
country: Japan
facility: Omi Medical Center
city: Tochigi
country: Japan
facility: NHO Utsunomiya Hospital
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Tokyo
country: Japan
facility: Showa University East Hospital
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Tokyo
country: Japan
facility: Tokyo Shinagawa Hospital
city: Yamaguchi
country: Japan
facility: NHO Iwakuni Clinical Center
Study officials:
References: