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

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

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Biological: Novaferon
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Inhaled Novaferon, given 20 ug BID, daily for 7 days | Biological: Novaferon<br>* a novel recombinant antiviral protein drug<br>|
| Placebo Comparator: Placebo<br>Inhaled saline (placebo), given BID, daily for 7 days | Biological: Placebo<br>* Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Mortality rate | Mortality rate | At Day 28 | 
| Duration of hospital stay | Number of days the patient is in hospital | From enrollment up to Day 28 | 
| 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 | 
| Requirement of supplemental oxygen | Rate at which patients require supplemental oxygen | From enrollment up to Day 28 | 
| Requirement of mechanical ventilation | Rate at which patients require mechanical ventilation (invasive or non-invasive) | From enrollment up to Day 28 | 
| Rate of alive patients | Rate of patients alive without having to use invasive ventilator or ECMO | At Day 28 | 
| Adverse events | Adverse event incidence, type and severity | From enrollment up to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID19, antiviral