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

Sponsor
Genova Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04669015
Collaborator
(none)
914
Enrollment
88
Locations
2
Arms
13.7
Anticipated Duration (Months)
10.4
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: Novaferon
  • Biological: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Jun 10, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • Standard of Care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of clinical deterioration [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 [From enrollment to Day 28]

      Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3)

    2. Hospital discharge rate [At Day 28]

      Rate of non-hospitalized alive patients

    3. Mortality rate [At Day 28]

      Mortality rate

    4. Duration of hospitalization [Up to Day 28]

      Number of days hospitalized

    5. Adverse events [From first dose to Day 56]

      Adverse event incidence, type and severity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Inclusion Criteria:

    1. 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.

    2. Men and women, ≥18 years of age at time of enrollment.

    3. 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 only at the time of screening).

    4. Less than or equal to 9 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.

    1. Hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (WHO category 4 or 5)

    2. Female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. Male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. For a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to Appendix 1.

    Exclusion Criteria:
    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.

    2. Currently undergoing invasive mechanical ventilation (including venous ECMO).

    3. Inability to use a nebulizer with a mouthpiece.

    4. ALT/AST > 5 times the Upper Limit of Normal (ULN) or a history of decompensated cirrhosis.

    5. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min/ 1.73m2).

    6. 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.

    7. 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.

    8. Possibility of the patient being discharged from hospital within 24 hours.

    9. Concurrent participation in other anti-COVID-19 therapeutic or interventional trials. Patients may, at the discretion of the Investigator, concurrently participate in other non-interventional COVID-19 studies.

    10. Prior or concurrent use of experimental antiviral therapy for COVID-19 (see Appendix

    12. Prior or concurrent use of any interferons other than the investigational product (see Appendix 2)

    13. Other known active infections or other clinical conditions (e.g., severe chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation.

    14. Patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease, or patients with prior transplants.

    15. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.

    16. The subject has any medical condition that in the opinion of the investigator would compromise subject's safety or compliance with study procedures.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Interzonal General de Agudos Dr Jose Penna Bahia Blanca Argentina
    2 CEMIC Ciudad Autonoma Buenos Aires Argentina
    3 Clinica Adventista Belgrano Ciudad Autonoma Buenos Aires Argentina
    4 Clinica Zabala Ciudad Autonoma de Buenos Aires Argentina
    5 Hospital San Roque Cordoba Argentina
    6 Sanatorio del Salvador Privado S.A. Cordoba Argentina
    7 Sanatorio Privado Duarte Quiroz De Clinica Colombo SA Cordoba Argentina
    8 Instituto Medico Rio Cuarto Rio Cuarto Argentina
    9 Clinica Central S.A. Villa Regina Argentina
    10 HCPA- Hospital de Clínicas de Porto Alegre Alegre Brazil
    11 Fundação PIO XII Hospital de Amor de Barretos Barretos Brazil
    12 Hospital Casa de Saúde Vera Cruz (Coordenador) Campinas Brazil
    13 Hospital São José Criciúma Brazil
    14 Hospital das Clínicas UFG Goiânia Brazil
    15 Hospital Geral Prof. Dr. Waldemar de Carvalho Pinto Filho de Guarulhos - BR TRIALS Guarulhos Brazil
    16 Hospital Felício Rocho Horizonte Brazil
    17 Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho Jaú Brazil
    18 CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Natal Brazil
    19 Hospital São Luiz de Jabaquara Porto Alegre Brazil
    20 Santa Casa de Misericórdia de Porto Alegre Porto Alegre Brazil
    21 Hospital 9 de Julho São Paulo Brazil
    22 Hospital São Luiz de Jabaquara São Paulo Brazil
    23 Instituto de Moléstias Cardiovalsculares Tatuí Ltda Tatuí Brazil
    24 Lobus Centro de Pesquisa Volta Redonda Brazil
    25 Lóbus Centro de Pesquisa Clínica Volta Redonda Brazil
    26 University Hospital - London Health Sciences Centre London Canada
    27 Victoria Hospital -London Health Sciences Centre London Canada
    28 St Paul's Hospital Vancouver Canada
    29 St. Boniface Hospital Winnipeg Canada
    30 Hospital Base Osorno Osorno Chile
    31 Hospital Sotero del Rio Santiago Chile
    32 Fundacion Cardiovascular de Colombia - Instituto del Carazon Floridablanco Floridablanca Santander Colombia
    33 Clinica de la Costa Ltda Barranquilla Colombia
    34 Fundacion Hospital Universidad del Norte Barranquilla Colombia
    35 Fundacion Oftalmologica Floridablanca Colombia
    36 Clinica SOMER Medellín Colombia
    37 Corporacion Clinica Villavicencio Colombia
    38 RS Universitas Udayana Bali Indonesia 80361
    39 Royal Taruma Hospital Jakarta Indonesia
    40 M. Djamil Hospital Padang Indonesia
    41 Sardjito Hospital Yogyakarta Indonesia
    42 KEMRI Kericho Kericho Kenya
    43 KEMRI/CGHR Siaya Clinical Research Annexe Kisumu Kenya
    44 Victoria Biomedical Research Institute Kisumu Kenya
    45 CREATES - Strathmore University Medical Centre Nairobi Kenya
    46 Kenyatta National Hospital Nairobi Kenya
    47 University Malaya Medical Centre Kuala Lumpur Malaysia
    48 Hospital Miri Miri Malaysia
    49 Sunway Medical Centre Petaling Jaya Malaysia
    50 HPUPM Serdang Malaysia
    51 Centro Medico Naval Cirujano Mayor Santiago Tavara Callao Peru
    52 Hospital Nacional Arzobispo Loayza Lima Cercado Peru
    53 Hospital III Daniel Alcides Carrion - Red Essalud de Tacna Lima Peru
    54 Hospital Nacional Dos de Mayo Lima Peru
    55 Tiervlei Trial Centre Cape Town South Africa
    56 Tread Research Cape Town South Africa
    57 Johese Clinical Research: Unitas Centurion South Africa
    58 Drs Sarvan and Moodley Durban South Africa
    59 TASK Eden George South Africa
    60 MERC SiReN Johannesburg South Africa
    61 Nelson Mandela Academic Clinical Research Unit (NeMACRU) Mthatha South Africa
    62 Into Research Pretoria South Africa
    63 Dr JM Engelbrecht Trial Site Somerset West South Africa
    64 Clinical Projects Research SA (PTY) LTD Worcester South Africa
    65 Ankara City Hospital Ankara Turkey
    66 Hacettepe University Medical Faculty Ankara Turkey
    67 Dicle University, Medical Faculty Diyarbakir Turkey
    68 Acibadem Atakent Hospital Istanbul Turkey
    69 Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Istanbul Turkey
    70 Kartal Lutfi Kirdar Research and Training Hospital Istanbul Turkey
    71 Ege University Medical Faculty Izmir Turkey
    72 Kayseri City Hospital Kayseri Turkey
    73 Kocaeli Universitesi Tip Fakultesi Kocaeli Turkey
    74 Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi Konya Turkey
    75 Ondokuz Mayis Univ. Med. Fac. Samsun Turkey
    76 Karadeniz Tecnical Uni. Med. Fac. Trabzon Turkey
    77 CI Dnipropetrovsk CCH #6 of DRC Dept of Therapy (with pulmonological beds) SI DMA of MoHU Dnipro Ukraine
    78 CNE CCH #16 of Dnipro City Council, DSMU, Ch of Intern Med #1 Dnipro Ukraine
    79 CNE Ivano-Frankivsk Reg Clin Infectious Hospital of Ivano-Frankivsk Regional Council Ivano-Frankivsk Ukraine
    80 CNE of Kharkov RC Reg Cl Infectious Hospital Kharkiv Ukraine
    81 Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1" Kremenchuk Ukraine
    82 Kyiv Municipal Clinical Hospital #17 O. O. Bogomolets NMU Kyiv Ukraine
    83 City Hospital #1 Mykolaiv Ukraine
    84 City Clinical infectious Hospital Odesa Ukraine
    85 Poltava Regional Clinical Infectious Hospital Dept of Diagnostics HSEIU Ukrainian Medical Stomatolog Poltava Ukraine
    86 Municipal Non-Profit Enterprise Central City Hospital Of Rivne City Council Rivne Ukraine
    87 CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases Vinnytsia Ukraine
    88 CI Central City Hospital #1 of Zhytomyr Zhytomyr Ukraine

    Sponsors and Collaborators

    • Genova Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genova Inc.
    ClinicalTrials.gov Identifier:
    NCT04669015
    Other Study ID Numbers:
    • JH-COR-003
    First Posted:
    Dec 16, 2020
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 3, 2022