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Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19 (NOVATION-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04669015
Recruitment Status : Not yet recruiting
First Posted : December 16, 2020
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Genova Inc.

Brief Summary:

This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed with COVID-19. The study is comprised of two cohorts:

  • Cohort A: This is a blinded safety lead-in comprising two arms. 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus Standard of Care (SOC)
  • Cohort B: This is the main portion of the study, which comprises two arms. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC

Condition or disease Intervention/treatment Phase
Covid19 Biological: Novaferon Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 914 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: NOVATION-1: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon + SOC vs. Placebo + SOC in Hospitalized Adult Patients With Moderate to Severe COVID-19
Estimated Study Start Date : May 15, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Active plus SOC
Inhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care
Biological: Novaferon
a novel recombinant antiviral protein drug
Other Name: Standard of Care

Placebo Comparator: Placebo plus SOC
Inhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care
Biological: Placebo
Formulation vehicle
Other Name: Standard of Care




Primary Outcome Measures :
  1. Rate of clinical deterioration [ Time Frame: From enrollment to Day 28 ]
    Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8)


Secondary Outcome Measures :
  1. Rate of recovery [ Time Frame: From enrollment to Day 28 ]
    Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3)

  2. Hospital discharge rate [ Time Frame: At Day 28 ]
    Rate of non-hospitalized alive patients

  3. Mortality rate [ Time Frame: At Day 28 ]
    Mortality rate

  4. Duration of hospitalization [ Time Frame: Up to Day 28 ]
    Number of days hospitalized

  5. Adverse events [ Time Frame: From first dose to Day 56 ]
    Adverse event incidence, type and severity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures.
  • Men and women, ≥18 years of age at time of enrollment.
  • Laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by PCR, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if RT-PCR test result not available at the time of screening).
  • Less than or equal to 12 days from COVID-19 symptom onset to starting treatment.

    • Symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other COVID-19 symptoms as determined by the Investigator.
  • Hospitalized for no more than 4 days duration, and:

    • requiring supplemental oxygen by mask or tongs, or ii) non-invasive ventilation or iii) high-flow oxygen (WHO category 4 or 5)
  • Female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. Male patients must agree to use appropriate contraceptive methods to prevent pregnancy with their partner(s), during the study and up to post 30 days after the last dose of study drug. Female patients must be:

    • unable to have children (e.g., post-menopausal*, bilateral tubal ligation, hysterectomy, bilateral oophorectomy) or where the partner is sterile (e.g., vasectomy) OR
    • willing to remain abstinent (not engage in sexual intercourse for the duration of the screening period and throughout the study, and for 30 days after the last dose) OR
    • willing to use two effective barrier methods of birth control (partner using condom and female using IUD, hormonal or nonhormonal contraceptive, diaphragm plus spermicide, or contraceptive sponge)

Exclusion Criteria:

  • 1. Known hypersensitivity or intolerance to Interferon (IFN) or Novaferon or any excipient(s) of Novaferon, including pre-existing allergy or hypersensitivity to ampicillin.
  • Currently undergoing invasive mechanical ventilation (including venous ECMO).
  • Inability to use a nebulizer with a mouthpiece.
  • ALT/AST > 5 times the upper limit of normal or a history of decompensated cirrhosis.
  • Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min/ 1.73m2).
  • In the opinion of the Investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment.
  • In the opinion of the Investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment.
  • Possibility of the patient being discharged from hospital within 24 hours.
  • Participation in other anti-COVID-19 therapeutic or interventional trials. Patients may, at the discretion of the Investigator, participate in other non-interventional COVID-19 studies.
  • Current use of other antiviral therapy (e.g. remdesivir, etc.) or other experimental therapy, including anti-inflammatory agents, convalescent plasma, or hydroxychloroquine
  • Has received, or has a plan to receive within the 28 day treatment period, a SARS-CoV-2 vaccine.
  • Use of immunomodulatory drugs at, or within 3 months prior to, enrollment; use of chronic oral corticosteroids for a non-COVID-19-related condition at a dose higher than prednisone 20 mg (or equivalent) per day for the preceding 4 weeks.
  • Other known active infections or other clinical conditions (e.g. chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed.
  • Patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants.
  • Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
  • Positive for hepatitis B, hepatitis C or uncontrolled HIV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669015


Contacts
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Contact: Dimitri Fitsialos (888) 370-9330 dfitsialos@integratedtsi.com

Locations
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Colombia
Fundacion Cardiovascular de Colombia - Instituto del Carazon Floridablanco
Floridablanca, Santander, Colombia
Contact: Reyes Martinez, MD         
Sponsors and Collaborators
Genova Inc.
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Responsible Party: Genova Inc.
ClinicalTrials.gov Identifier: NCT04669015    
Other Study ID Numbers: JH-COR-003
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genova Inc.:
antiviral
SARS-CoV-2
COVID19