This study is a randomized, double-blind, multicenter, placebo-controlled trial toevaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalizedadult 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
Not Provided
Biological: Novaferon
a novel recombinant antiviral protein drug
Other Name: Standard of Care
Biological: Placebo
Formulation vehicle
Other Name: Standard of Care
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.
5. 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)
6. 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
2.
11. Prior or concurrent use of any interferons other than the investigational product
(see Appendix 2)
12. Other known active infections or other clinical conditions (e.g., severe chronic
obstructive pulmonary disease) that contraindicate aerosolized inhalation.
13. Patients with current or prior psychiatric illness, seizure disorders, retinal
autoimmune disorders, pre-existing severe cardiovascular disease, or patients with
prior transplants.
14. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
15. The subject has any medical condition that in the opinion of the investigator would
compromise subject's safety or compliance with study procedures.
Hospital Interzonal General de Agudos Dr Jose Penna
Bahia Blanca, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, Argentina
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina
Clinica Zabala
Ciudad Autonoma de Buenos Aires, Argentina
Hospital San Roque
Cordoba, Argentina
Sanatorio del Salvador Privado S.A.
Cordoba, Argentina
Sanatorio Privado Duarte Quiroz De Clinica Colombo SA
Cordoba, Argentina
Instituto Medico Rio Cuarto
Rio 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, 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, 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 Nacional Arzobispo Loayza
Lima Cercado, Peru
Hospital III Daniel Alcides Carrion - Red Essalud de Tacna
Lima, Peru
Hospital Nacional Dos de Mayo
Lima, 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
Hacettepe University Medical Faculty
Ankara, Turkey
Dicle University, Medical Faculty
Diyarbakir, Turkey
Acibadem Atakent Hospital
Istanbul, Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, Turkey
Kartal Lutfi Kirdar Research and Training Hospital
Istanbul, Turkey
Ege University Medical Faculty
Izmir, Turkey
Kayseri City Hospital
Kayseri, Turkey
Kocaeli Universitesi Tip Fakultesi
Kocaeli, Turkey
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
Konya, Turkey
Ondokuz Mayis Univ. Med. Fac.
Samsun, Turkey
Karadeniz Tecnical Uni. Med. Fac.
Trabzon, Turkey
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
Huimei Huang
+6582027938
hhuang@genova.cn
Wang Joyce
(1 604) 306 6003
JOYCE
Not Provided