Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19
NCT ID: NCT04669015
Last Updated: 2022-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
914 participants
INTERVENTIONAL
2021-06-10
2022-08-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active plus SOC
Inhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care
Novaferon
a novel recombinant antiviral protein drug
Placebo plus SOC
Inhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care
Placebo
Formulation vehicle
Interventions
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Novaferon
a novel recombinant antiviral protein drug
Placebo
Formulation vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Genova Inc.
INDUSTRY
Responsible Party
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Locations
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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, , 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
Countries
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Central Contacts
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Facility Contacts
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Ditondo Juan Carlos, MD
Role: primary
Iastrebner Claudio Marcelo, MD
Role: primary
Valentini Ricardo, MD
Role: primary
Casas Marcelo Martin, MD
Role: primary
Parody Maria Leonor, MD
Role: primary
Garcia Nestor Horacio, MD
Role: primary
Colombo Hugo, MD
Role: primary
D'Andrea Nores Ulises, MD
Role: primary
Ariza Horacio Alberto, MD
Role: primary
Eduardo Sprinz, MD
Role: primary
Cesar Mauricio da Silva, MD
Role: primary
Florentino de Araujo Cardoso Filho, MD
Role: primary
Felipe Dal Pizzol, MD
Role: primary
Daniela Graner Schuwartz Tannus Silva, MD
Role: primary
Paulo Fernando Tierno, MD
Role: primary
Thaís de Paula Guimarães, MD
Role: primary
Patrícia Medeiros Milhomem Beato, MD
Role: primary
Kleber Giovanni Luz, MD
Role: primary
Oscar Pereira Dutra, MD
Role: primary
Cláudio Marcel Berdun Stadnik, MD
Role: primary
Celso Mitsushi Massumoto, MD
Role: primary
Daniel Wagner de Castro Lima Santos, MD
Role: primary
Wladmir Faustino Saporito, MD
Role: primary
Vicente Junior, MD
Role: primary
Vicente Lopes da Silva Júnior, MD
Role: primary
Sarah Shalhoub, MD
Role: primary
Sarah Shalhoub, MD
Role: primary
John Boyd, MD
Role: primary
Gloria Vazquez-Grande, MD
Role: primary
Bernardo Goecke Hochberger, MD
Role: primary
Reyes Martinez, Carlos Fernando, MD
Role: primary
Shirley Patricia Iglesias, MD
Role: primary
Hugo Macareno Arroyo, MD
Role: primary
Juan Diego Higuera Cobos, MD
Role: primary
Gomez Vega, Cristian Jose, MD
Role: primary
Franco Rodriguez, Adriana Paola, MD
Role: primary
Wahyu Purnamasidhi Cokorda Agung, MD
Role: primary
Erni Juwita Nelwan, MD
Role: primary
Irvan Medison, MD
Role: primary
Harik Firman Thahadian, MD
Role: primary
Isaac Tsikhutsu, MD
Role: primary
Kevin K Orimba, MD
Role: primary
Lucas Otieno Tina, MD
Role: primary
Bernhards Ogutu, MD
Role: primary
John Kinuthia, MD
Role: primary
Sharifah Faridah Syed Omar, MD
Role: primary
Ting Ingrid Pao Lin, MD
Role: primary
Kow Ken Siong, MD
Role: primary
Daut Ummi Nadira, MD
Role: primary
Emma Mercedes Huamani de la Cruz, MD
Role: primary
Miguel Hueda, MD
Role: primary
Cesar Augusto Gamarra Ayarza, MD
Role: primary
Zandra Moncada Vilela, MD
Role: primary
Matthys Basson, MD
Role: primary
Lesley Burgess, MD
Role: primary
Rani Elenjical, MD
Role: primary
Mahomed Sarvan, MD
Role: primary
Kirsten McHarry, MD
Role: primary
Natasha Joseph, MD
Role: primary
Thozama Dubula, MD
Role: primary
Richard Siebert, MD
Role: primary
Johannes Engelbrecht, MD
Role: primary
Louis van Zyl, MD
Role: primary
Rahmet Guner, MD
Role: primary
Serhat Unal, MD
Role: primary
Mustafa Kemal Celen, MD
Role: primary
Iftihar Koksal, MD
Role: primary
Fehmi Tabak, MD
Role: primary
Ayse Batirel, MD
Role: primary
Husnu Pullukcu, MD
Role: primary
Ilhami Celik, MD
Role: primary
Sila Cetin Akhan, MD
Role: primary
Fikret Kanat, MD
Role: primary
Ilkay Bozkurt
Role: primary
Firdevs Aksoy, MD
Role: primary
Kseniia Bielosludtseva, MD
Role: primary
Tetiana Kirieieva, MD
Role: primary
Oleksandra Pryshliak, MD
Role: primary
Anatoliy Gavrylov, MD
Role: primary
Viktoriia Vypovska, MD
Role: primary
Sergii Dubrov, MD
Role: primary
Valeriy Molodtsov, MD
Role: primary
Svitlana Lavryukova, MD
Role: primary
Tetiana Koval, MD
Role: primary
Halyna Martynyuk, MD
Role: primary
Larysa Moroz, MD
Role: primary
Ivan Vyshnyvetskyy, MD
Role: primary
Other Identifiers
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JH-COR-003
Identifier Type: -
Identifier Source: org_study_id
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