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

Phase 3

• Conditions: Covid19
• Interventions: Biological: Novaferon; Biological: Placebo

• Registration Number: NCT04708158
• Lead Sponsor: Genova Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Study Start: 2021-03-25
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 385

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Novaferon	Inhaled Novaferon, given 20 ug BID, daily for 7 days
Placebo	Placebo	Inhaled saline (placebo), given BID, daily for 7 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 alive patients	At Day 28	Rate of patients alive without having to use invasive ventilator or ECMO
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 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
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 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
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
Adverse events	From enrollment up to Day 28	Adverse event incidence, type and severity

Trial Locations

Locations (22)

Omi Medical Center; 🇯🇵 Shiga, Japan

Kamagaya General Hospital; 🇯🇵 Chiba, Japan

Chiba Aoba Municipal Hospital; 🇯🇵 Chiba, Japan

NHO Chiba Medical Center; 🇯🇵 Chiba, Japan

NHO Omuta National Hospital; 🇯🇵 Fukuoka, Japan

Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital; 🇯🇵 Ibaraki, Japan

NHO Kasumigaura Medical Center; 🇯🇵 Ibaraki, Japan

Kokankai Nippon Kokan Hospital; 🇯🇵 Kanagawa, Japan

Rakuwakai Otowa Hospital; 🇯🇵 Kyoto, Japan

Rinku General Medical Center; 🇯🇵 Osaka, Japan

Okayama City General Medical Center Okayama City Hospital; 🇯🇵 Okayama, Japan

Osaka Habikino Medical Center; 🇯🇵 Osaka, Japan

Sakai City Medical Center; 🇯🇵 Osaka, 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