Novaferon for COVID-19 Treatment Trial (NCTT-005)

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04708158
• Other study ID #: JH-COR-005
• Status: Recruiting
• Phase: Phase 3
• Start date: March 25, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: December 2021
• Source: Genova Inc.
• Contact: Huimei Huang
• Phone: +6582027938
• Email: hhuang[@]genova.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 385
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• Novaferon
a novel recombinant antiviral protein drug
• Placebo
Saline

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Genova Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of clinical improvement	Rate at which patients show a clinical improvement by 2 points on a 7-point ordinal scale	Day 1 to Day 10, 14 and 28
Secondary	Rate of clinical deterioration	Rate at which patients show a clinical deterioration by 2 points on a 7-point ordinal scale	Day 1 to Day 10, 14 and 28
Secondary	Time to viral clearance	Time taken for patients to demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs	From enrollment up to Day 28
Secondary	Rate of viral clearance	The rate at which patients demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs	Each Day from Day 1 up to Day 28
Secondary	Change in viral load	Changes of SARS-CoV-2 viral loads in the samples of nasopharyngeal swabs	Each Day from Day 1 up to Day 28
Secondary	Mortality rate	Mortality rate	At Day 28
Secondary	Duration of hospital stay	Number of days the patient is in hospital	From enrollment up to Day 28
Secondary	Time to resolution of symptoms	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	From enrollment up to Day 28
Secondary	Requirement of supplemental oxygen	Rate at which patients require supplemental oxygen	From enrollment up to Day 28
Secondary	Requirement of mechanical ventilation	Rate at which patients require mechanical ventilation (invasive or non-invasive)	From enrollment up to Day 28
Secondary	Rate of alive patients	Rate of patients alive without having to use invasive ventilator or ECMO	At Day 28
Secondary	Adverse events	Adverse event incidence, type and severity	From enrollment up to Day 28