Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19
- Conditions
- Covid19
- Interventions
- Biological: NovaferonBiological: Placebo
- Registration Number
- NCT04669015
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 914
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 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.
Exclusion Criteria:
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active plus SOC Novaferon Inhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care Placebo plus SOC Placebo Inhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care
- Primary Outcome Measures
Name Time Method 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
Name Time Method Mortality rate At Day 28 Mortality rate
Duration of hospitalization Up to Day 28 Number of days hospitalized
Rate of recovery From enrollment to Day 28 Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3)
Hospital discharge rate At Day 28 Rate of non-hospitalized alive patients
Adverse events From first dose to Day 56 Adverse event incidence, type and severity
Trial Locations
- Locations (87)
Hospital Felício Rocho
🇧🇷Horizonte, Brazil
Hospital 9 de Julho
🇧🇷São Paulo, Brazil
Instituto de Moléstias Cardiovalsculares Tatuí Ltda
🇧🇷Tatuí, Brazil
M. Djamil Hospital
🇮🇩Padang, Indonesia
Kartal Lutfi Kirdar Research and Training Hospital
🇹🇷Istanbul, Turkey
Kayseri City Hospital
🇹🇷Kayseri, Turkey
KEMRI Kericho
🇰🇪Kericho, Kenya
CNE Ivano-Frankivsk Reg Clin Infectious Hospital of Ivano-Frankivsk Regional Council
🇺🇦Ivano-Frankivsk, Ukraine
Hospital Miri
🇲🇾Miri, Malaysia
Hospital III Daniel Alcides Carrion - Red Essalud de Tacna
🇵🇪Lima, Peru
CI Central City Hospital #1 of Zhytomyr
🇺🇦Zhytomyr, Ukraine
Hospital Interzonal General de Agudos Dr Jose Penna
🇦🇷Bahia Blanca, Argentina
Clinica Zabala
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Instituto Medico Rio Cuarto
🇦🇷Rio Cuarto, Argentina
HCPA- Hospital de Clínicas de Porto Alegre
🇧🇷Alegre, Brazil
CEMIC
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Sanatorio del Salvador Privado S.A.
🇦🇷Cordoba, Argentina
Hospital São José
🇧🇷Criciúma, Brazil
Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Lóbus Centro de Pesquisa Clínica
🇧🇷Volta Redonda, Brazil
Clinica Adventista Belgrano
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Clinica Central S.A.
🇦🇷Villa Regina, Argentina
Hospital Geral Prof. Dr. Waldemar de Carvalho Pinto Filho de Guarulhos - BR TRIALS
🇧🇷Guarulhos, Brazil
Hospital São Luiz de Jabaquara
🇧🇷São Paulo, Brazil
Hospital Sotero del Rio
🇨🇱Santiago, Chile
Fundacion Oftalmologica
🇨🇴Floridablanca, Colombia
Clinica SOMER
🇨🇴Medellín, Colombia
KEMRI/CGHR Siaya Clinical Research Annexe
🇰🇪Kisumu, Kenya
Into Research
🇿🇦Pretoria, South Africa
Sanatorio Privado Duarte Quiroz De Clinica Colombo SA
🇦🇷Cordoba, Argentina
Fundação PIO XII Hospital de Amor de Barretos
🇧🇷Barretos, Brazil
Hospital Casa de Saúde Vera Cruz (Coordenador)
🇧🇷Campinas, Brazil
Hospital das Clínicas UFG
🇧🇷Goiânia, Brazil
CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas
🇧🇷Natal, Brazil
Victoria Hospital -London Health Sciences Centre
🇨🇦London, Canada
St Paul's Hospital
🇨🇦Vancouver, Canada
Victoria Biomedical Research Institute
🇰🇪Kisumu, Kenya
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Clinical Projects Research SA (PTY) LTD
🇿🇦Worcester, South Africa
Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho
🇧🇷Jaú, Brazil
Lobus Centro de Pesquisa
🇧🇷Volta Redonda, Brazil
University Hospital - London Health Sciences Centre
🇨🇦London, Canada
Hospital Base Osorno
🇨🇱Osorno, Chile
St. Boniface Hospital
🇨🇦Winnipeg, Canada
Corporacion Clinica
🇨🇴Villavicencio, Colombia
RS Universitas Udayana
🇮🇩Bali, Indonesia
Sardjito Hospital
🇮🇩Yogyakarta, Indonesia
Clinica de la Costa Ltda
🇨🇴Barranquilla, Colombia
Royal Taruma Hospital
🇮🇩Jakarta, Indonesia
Fundacion Cardiovascular de Colombia - Instituto del Carazon Floridablanco
🇨🇴Floridablanca, Santander, Colombia
Fundacion Hospital Universidad del Norte
🇨🇴Barranquilla, Colombia
HPUPM
🇲🇾Serdang, Malaysia
Hospital Nacional Dos de Mayo
🇵🇪Lima, Peru
Tiervlei Trial Centre
🇿🇦Cape Town, South Africa
Sunway Medical Centre
🇲🇾Petaling Jaya, Malaysia
Centro Medico Naval Cirujano Mayor Santiago Tavara
🇵🇪Callao, Peru
Hospital Nacional Arzobispo Loayza
🇵🇪Lima Cercado, Peru
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Acibadem Atakent Hospital
🇹🇷Istanbul, Turkey
Tread Research
🇿🇦Cape Town, South Africa
Ankara City Hospital
🇹🇷Ankara, Turkey
Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1"
🇺🇦Kremenchuk, Ukraine
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
🇹🇷Istanbul, Turkey
Dicle University, Medical Faculty
🇹🇷Diyarbakir, Turkey
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
🇹🇷Konya, Turkey
Ondokuz Mayis Univ. Med. Fac.
🇹🇷Samsun, Turkey
Karadeniz Tecnical Uni. Med. Fac.
🇹🇷Trabzon, Turkey
City Hospital #1
🇺🇦Mykolaiv, Ukraine
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
City Clinical infectious Hospital
🇺🇦Odesa, Ukraine
Municipal Non-Profit Enterprise Central City Hospital Of Rivne City Council
🇺🇦Rivne, Ukraine
Kyiv Municipal Clinical Hospital #17 O. O. Bogomolets NMU
🇺🇦Kyiv, Ukraine
CNE of Kharkov RC Reg Cl Infectious Hospital
🇺🇦Kharkiv, Ukraine
Poltava Regional Clinical Infectious Hospital Dept of Diagnostics HSEIU Ukrainian Medical Stomatolog
🇺🇦Poltava, Ukraine
Johese Clinical Research: Unitas
🇿🇦Centurion, South Africa
MERC SiReN
🇿🇦Johannesburg, South Africa
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
🇿🇦Mthatha, South Africa
Dr JM Engelbrecht Trial Site
🇿🇦Somerset West, South Africa
Hospital San Roque
🇦🇷Cordoba, Argentina
CREATES - Strathmore University Medical Centre
🇰🇪Nairobi, Kenya
TASK Eden
🇿🇦George, South Africa
Drs Sarvan and Moodley
🇿🇦Durban, South Africa
Kocaeli Universitesi Tip Fakultesi
🇹🇷Kocaeli, Turkey
CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases
🇺🇦Vinnytsia, Ukraine
Kenyatta National Hospital
🇰🇪Nairobi, Kenya