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

Covid19 Clinical Trial

— NOVATION-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04669015
• Other study ID #: JH-COR-003
• Status: Recruiting
• Phase: Phase 3
• Start date: June 10, 2021
• Est. completion date: August 2022

Study information

• Verified date: June 2022
• Source: Genova Inc.
• Contact: Huimei Huang
• Phone: +6582027938
• Email: hhuang[@]genova.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 914
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• Novaferon
a novel recombinant antiviral protein drug
• Placebo
Formulation vehicle

Locations

Country	Name	City	State
Argentina	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
Brazil	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
Canada	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
Chile	Hospital Base Osorno	Osorno
Chile	Hospital Sotero del Rio	Santiago
Colombia	Clinica de la Costa Ltda	Barranquilla
Colombia	Fundacion Hospital Universidad del Norte	Barranquilla
Colombia	Fundacion Cardiovascular de Colombia - Instituto del Carazon Floridablanco	Floridablanca	Santander
Colombia	Fundacion Oftalmologica	Floridablanca
Colombia	Clinica SOMER	Medellín
Colombia	Corporacion Clinica	Villavicencio
Indonesia	RS Universitas Udayana	Bali
Indonesia	Royal Taruma Hospital	Jakarta
Indonesia	M. Djamil Hospital	Padang
Indonesia	Sardjito Hospital	Yogyakarta
Kenya	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
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Miri	Miri
Malaysia	Sunway Medical Centre	Petaling Jaya
Malaysia	HPUPM	Serdang
Peru	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
South Africa	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
Turkey	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
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Genova Inc.

Countries where clinical trial is conducted

Argentina,  Brazil,  Canada,  Chile,  Colombia,  Indonesia,  Kenya,  Malaysia,  Peru,  South Africa,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of recovery	Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3)	From enrollment to Day 28
Secondary	Hospital discharge rate	Rate of non-hospitalized alive patients	At Day 28
Secondary	Mortality rate	Mortality rate	At Day 28
Secondary	Duration of hospitalization	Number of days hospitalized	Up to Day 28
Secondary	Adverse events	Adverse event incidence, type and severity	From first dose to Day 56