Novaferon for COVID-19 Treatment Trial (NCTT-005)
Study Details
Study Description
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active Inhaled Novaferon, given 20 ug BID, daily for 7 days |
Biological: Novaferon
a novel recombinant antiviral protein drug
|
| Placebo Comparator: Placebo Inhaled saline (placebo), given BID, daily for 7 days |
Biological: Placebo
Saline
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chiba Aoba Municipal Hospital | Chiba | Japan | ||
| 2 | Kamagaya General Hospital | Chiba | Japan | ||
| 3 | NHO Chiba Medical Center | Chiba | Japan | ||
| 4 | NHO Omuta National Hospital | Fukuoka | Japan | ||
| 5 | NHO Kasumigaura Medical Center | Ibaraki | Japan | ||
| 6 | Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital | Ibaraki | Japan | ||
| 7 | Kokankai Nippon Kokan Hospital | Kanagawa | Japan | ||
| 8 | Rakuwakai Otowa Hospital | Kyoto | Japan | ||
| 9 | Okayama City General Medical Center Okayama City Hospital | Okayama | Japan | ||
| 10 | Osaka Habikino Medical Center | Osaka | Japan | ||
| 11 | Rinku General Medical Center | Osaka | Japan | ||
| 12 | Sakai City Medical Center | Osaka | Japan | ||
| 13 | Omi Medical Center | Shiga | Japan | ||
| 14 | NHO Utsunomiya Hospital | Tochigi | Japan | ||
| 15 | Japanese Red Cross Medical Center | Tokyo | Japan | ||
| 16 | Juntendo University Hospital | Tokyo | Japan | ||
| 17 | Nihon University Itabashi Hospital | Tokyo | Japan | ||
| 18 | Showa University East Hospital | Tokyo | Japan | ||
| 19 | Showa University Hospital | Tokyo | Japan | ||
| 20 | Tokyo Medical University Hachioji Medical Center | Tokyo | Japan | ||
| 21 | Tokyo Shinagawa Hospital | Tokyo | Japan | ||
| 22 | NHO Iwakuni Clinical Center | Yamaguchi | Japan |
Sponsors and Collaborators
- Genova Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JH-COR-005