Novaferon for COVID-19 Treatment Trial (NCTT-005)
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
1 other identifier
interventional
385
1 country
22
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Mar 2021
Longer than P75 for phase_3 covid19
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
March 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedJanuary 28, 2022
December 1, 2021
2.1 years
January 12, 2021
January 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to clinical improvement
Time to patient clinical improvement by 2 points on a 7-point ordinal scale
From enrollment up to Day 28
Secondary Outcomes (12)
Rate of clinical improvement
Day 1 to Day 10, 14 and 28
Rate of clinical deterioration
Day 1 to Day 10, 14 and 28
Time to viral clearance
From enrollment up to Day 28
Rate of viral clearance
Each Day from Day 1 up to Day 28
Change in viral load
Each Day from Day 1 up to Day 28
- +7 more secondary outcomes
Study Arms (2)
Active
EXPERIMENTALInhaled Novaferon, given 20 ug BID, daily for 7 days
Placebo
PLACEBO COMPARATORInhaled saline (placebo), given BID, daily for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genova Inc.lead
Study Sites (22)
Chiba Aoba Municipal Hospital
Chiba, Japan
Kamagaya General Hospital
Chiba, Japan
NHO Chiba Medical Center
Chiba, Japan
NHO Omuta National Hospital
Fukuoka, Japan
NHO Kasumigaura Medical Center
Ibaraki, Japan
Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital
Ibaraki, Japan
Kokankai Nippon Kokan Hospital
Kanagawa, Japan
Rakuwakai Otowa Hospital
Kyoto, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, Japan
Osaka Habikino Medical Center
Osaka, Japan
Rinku General Medical Center
Osaka, Japan
Sakai City Medical Center
Osaka, Japan
Omi Medical Center
Shiga, Japan
NHO Utsunomiya Hospital
Tochigi, Japan
Japanese Red Cross Medical Center
Tokyo, Japan
Juntendo University Hospital
Tokyo, Japan
Nihon University Itabashi Hospital
Tokyo, Japan
Showa University East Hospital
Tokyo, Japan
Showa University Hospital
Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, Japan
Tokyo Shinagawa Hospital
Tokyo, Japan
NHO Iwakuni Clinical Center
Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 13, 2021
Study Start
March 25, 2021
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
January 28, 2022
Record last verified: 2021-12