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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Active
    • Inhaled Novaferon, given 20 ug BID, daily for 7 days
  • Placebo Comparator: Placebo
    • Inhaled saline (placebo), given BID, daily for 7 days

Clinical Trial Outcome Measures

Primary Measures

  • Time to clinical improvement
    • Time Frame: From enrollment up to Day 28
    • Time to patient clinical improvement by 2 points on a 7-point ordinal scale

Secondary Measures

  • Rate of clinical improvement
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Each Day from Day 1 up to Day 28
    • Changes of SARS-CoV-2 viral loads in the samples of nasopharyngeal swabs
  • Mortality rate
    • Time Frame: At Day 28
    • Mortality rate
  • Duration of hospital stay
    • Time Frame: From enrollment up to Day 28
    • Number of days the patient is in hospital
  • Time to resolution of symptoms
    • Time Frame: 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
    • Time Frame: From enrollment up to Day 28
    • Rate at which patients require supplemental oxygen
  • Requirement of mechanical ventilation
    • Time Frame: From enrollment up to Day 28
    • Rate at which patients require mechanical ventilation (invasive or non-invasive)
  • Rate of alive patients
    • Time Frame: At Day 28
    • Rate of patients alive without having to use invasive ventilator or ECMO
  • Adverse events
    • Time Frame: From enrollment up to Day 28
    • Adverse event incidence, type and severity

Participating in This Clinical Trial

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 ÂșC 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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genova Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Haifeng Kin, +81-(0)9061636662, kkin@genova.cn

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