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

Last updated: January 13, 2022
Sponsor: Genova Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04708158
JH-COR-005
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent has been obtained from the participants with age of over 20years at the time of signing the informed consent.
  • SARS-CoV-2 infection is diagnosed by the positive SARS-CoV-2 detection of RT-PCR testswithin 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 theinvestigational 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 symptomsdefined 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 negativepregnancy test (urine hCG qualification) and agree to take oral contraceptives or usecondom during study period.

Exclusion

Exclusion Criteria:

  • History of hypersensitivity to interferon or Novaferon or any excipients of interferonor 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

Total Participants: 385
Study Start date:
March 25, 2021
Estimated Completion Date:
April 30, 2023

Connect with a study center

  • Chiba Aoba Municipal Hospital

    Chiba,
    Japan

    Active - Recruiting

  • Kamagaya General Hospital

    Chiba,
    Japan

    Active - Recruiting

  • NHO Chiba Medical Center

    Chiba,
    Japan

    Active - Recruiting

  • NHO Omuta National Hospital

    Fukuoka,
    Japan

    Site Not Available

  • NHO Kasumigaura Medical Center

    Ibaraki,
    Japan

    Active - Recruiting

  • Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital

    Ibaraki,
    Japan

    Site Not Available

  • Kokankai Nippon Kokan Hospital

    Kanagawa,
    Japan

    Active - Recruiting

  • Rakuwakai Otowa Hospital

    Kyoto,
    Japan

    Active - Recruiting

  • Okayama City General Medical Center Okayama City Hospital

    Okayama,
    Japan

    Active - Recruiting

  • Osaka Habikino Medical Center

    Osaka,
    Japan

    Active - Recruiting

  • Rinku General Medical Center

    Osaka,
    Japan

    Active - Recruiting

  • Sakai City Medical Center

    Osaka,
    Japan

    Active - Recruiting

  • Omi Medical Center

    Shiga,
    Japan

    Active - Recruiting

  • NHO Utsunomiya Hospital

    Tochigi,
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Tokyo,
    Japan

    Site Not Available

  • Juntendo University Hospital

    Tokyo,
    Japan

    Site Not Available

  • Nihon University Itabashi Hospital

    Tokyo,
    Japan

    Site Not Available

  • Showa University East Hospital

    Tokyo,
    Japan

    Site Not Available

  • Showa University Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Medical University Hachioji Medical Center

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Shinagawa Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • NHO Iwakuni Clinical Center

    Yamaguchi,
    Japan

    Active - Recruiting

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