Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19
NOVATION-1
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
1 other identifier
interventional
914
12 countries
88
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Jun 2021
Typical duration for phase_3 covid19
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2020
CompletedFirst Posted
Study publicly available on registry
December 16, 2020
CompletedStudy Start
First participant enrolled
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJune 3, 2022
June 1, 2022
1.1 years
December 14, 2020
June 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of clinical deterioration
Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8)
From enrollment to Day 28
Secondary Outcomes (5)
Rate of recovery
From enrollment to Day 28
Hospital discharge rate
At Day 28
Mortality rate
At Day 28
Duration of hospitalization
Up to Day 28
Adverse events
From first dose to Day 56
Study Arms (2)
Active plus SOC
EXPERIMENTALInhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care
Placebo plus SOC
PLACEBO COMPARATORInhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care
Interventions
Eligibility Criteria
You may qualify if:
- 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 only at the time of screening).
- 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.
- 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)
- 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.
You may not qualify if:
- 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 (ULN) 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.
- 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.
- Prior or concurrent use of experimental antiviral therapy for COVID-19 (see Appendix 2.
- Prior or concurrent use of any interferons other than the investigational product (see Appendix 2)
- Other known active infections or other clinical conditions (e.g., severe chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation.
- Patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease, or patients with prior transplants.
- Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
- The subject has any medical condition that in the opinion of the investigator would compromise subject's safety or compliance with study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genova Inc.lead
Study Sites (88)
Hospital Interzonal General de Agudos Dr Jose Penna
Bahía Blanca, Argentina
Clinica Zabala
Buenos Aires, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, Argentina
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina
Hospital San Roque
Córdoba, Argentina
Sanatorio del Salvador Privado S.A.
Córdoba, Argentina
Sanatorio Privado Duarte Quiroz De Clinica Colombo SA
Córdoba, Argentina
Instituto Medico Rio Cuarto
Río Cuarto, Argentina
Clinica Central S.A.
Villa Regina, Argentina
HCPA- Hospital de Clínicas de Porto Alegre
Alegre, Brazil
Fundação PIO XII Hospital de Amor de Barretos
Barretos, Brazil
Hospital Casa de Saúde Vera Cruz (Coordenador)
Campinas, Brazil
Hospital São José
Criciúma, Brazil
Hospital das Clínicas UFG
Goiânia, Brazil
Hospital Geral Prof. Dr. Waldemar de Carvalho Pinto Filho de Guarulhos - BR TRIALS
Guarulhos, Brazil
Hospital Felício Rocho
Horizonte, Brazil
Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho
Jaú, Brazil
CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas
Natal, Brazil
Hospital São Luiz de Jabaquara
Porto Alegre, Brazil
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Hospital 9 de Julho
São Paulo, Brazil
Hospital São Luiz de Jabaquara
São Paulo, Brazil
Instituto de Moléstias Cardiovalsculares Tatuí Ltda
Tatuí, Brazil
Lobus Centro de Pesquisa
Volta Redonda, Brazil
Lóbus Centro de Pesquisa Clínica
Volta Redonda, Brazil
University Hospital - London Health Sciences Centre
London, Canada
Victoria Hospital -London Health Sciences Centre
London, Canada
St Paul's Hospital
Vancouver, Canada
St. Boniface Hospital
Winnipeg, Canada
Hospital Base Osorno
Osorno, Chile
Hospital Sotero del Rio
Santiago, Chile
Fundacion Cardiovascular de Colombia - Instituto del Carazon Floridablanco
Floridablanca, Santander Department, Colombia
Clinica de la Costa Ltda
Barranquilla, Colombia
Fundacion Hospital Universidad del Norte
Barranquilla, Colombia
Fundacion Oftalmologica
Floridablanca, Colombia
Clinica SOMER
Medellín, Colombia
Corporacion Clinica
Villavicencio, Colombia
RS Universitas Udayana
Bali, 80361, Indonesia
Royal Taruma Hospital
Jakarta, Indonesia
M. Djamil Hospital
Padang, Indonesia
Sardjito Hospital
Yogyakarta, Indonesia
KEMRI Kericho
Kericho, Kenya
KEMRI/CGHR Siaya Clinical Research Annexe
Kisumu, Kenya
Victoria Biomedical Research Institute
Kisumu, Kenya
CREATES - Strathmore University Medical Centre
Nairobi, Kenya
Kenyatta National Hospital
Nairobi, Kenya
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Miri
Miri, Malaysia
Sunway Medical Centre
Petaling Jaya, Malaysia
HPUPM
Serdang, Malaysia
Centro Medico Naval Cirujano Mayor Santiago Tavara
Callao, Peru
Hospital III Daniel Alcides Carrion - Red Essalud de Tacna
Lima, Peru
Hospital Nacional Dos de Mayo
Lima, Peru
Hospital Nacional Arzobispo Loayza
Lima Cercado, Peru
Tiervlei Trial Centre
Cape Town, South Africa
Tread Research
Cape Town, South Africa
Johese Clinical Research: Unitas
Centurion, South Africa
Drs Sarvan and Moodley
Durban, South Africa
TASK Eden
George, South Africa
MERC SiReN
Johannesburg, South Africa
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Mthatha, South Africa
Into Research
Pretoria, South Africa
Dr JM Engelbrecht Trial Site
Somerset West, South Africa
Clinical Projects Research SA (PTY) LTD
Worcester, South Africa
Ankara City Hospital
Ankara, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Dicle University, Medical Faculty
Diyarbakır, Turkey (Türkiye)
Acibadem Atakent Hospital
Istanbul, Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Kartal Lutfi Kirdar Research and Training Hospital
Istanbul, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, Turkey (Türkiye)
Kayseri City Hospital
Kayseri, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, Turkey (Türkiye)
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
Konya, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.
Samsun, Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac.
Trabzon, Turkey (Türkiye)
CI Dnipropetrovsk CCH #6 of DRC Dept of Therapy (with pulmonological beds) SI DMA of MoHU
Dnipro, Ukraine
CNE CCH #16 of Dnipro City Council, DSMU, Ch of Intern Med #1
Dnipro, Ukraine
CNE Ivano-Frankivsk Reg Clin Infectious Hospital of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, Ukraine
CNE of Kharkov RC Reg Cl Infectious Hospital
Kharkiv, Ukraine
Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1"
Kremenchuk, Ukraine
Kyiv Municipal Clinical Hospital #17 O. O. Bogomolets NMU
Kyiv, Ukraine
City Hospital #1
Mykolaiv, Ukraine
City Clinical infectious Hospital
Odesa, Ukraine
Poltava Regional Clinical Infectious Hospital Dept of Diagnostics HSEIU Ukrainian Medical Stomatolog
Poltava, Ukraine
Municipal Non-Profit Enterprise Central City Hospital Of Rivne City Council
Rivne, Ukraine
CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases
Vinnytsia, Ukraine
CI Central City Hospital #1 of Zhytomyr
Zhytomyr, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2020
First Posted
December 16, 2020
Study Start
June 10, 2021
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
June 3, 2022
Record last verified: 2022-06