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Covid19Phase 3NOVATION-1NCT04669015

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

A Phase 3 study testing Novaferon in people with Covid19, run by Genova Inc. at 88 sites in 12 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Novaferon
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
914 participants
Where
88 sitesin 12 countries
Study dates
10 Jun 2021to Aug 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

88 sites in 12 countries.

Huimei Huang contact

+6582027938

hhuang@genova.cn

Wang Joyce contact

(1 604) 306 6003

JOYCE <jwy8890@gmail.com>

88 sites in 12 countries

Brazil16 sites, 16 recruiting

  • HCPA- Hospital de Clínicas de Porto Alegre

    Alegre

    Eduardo Sprinz, MD

    Eduardo Sprinz, MD

    Recruiting

  • Fundação PIO XII Hospital de Amor de Barretos

    Barretos

    Cesar Mauricio da Silva, MD

    Cesar Mauricio da Silva, MD

    Recruiting

  • Hospital Casa de Saúde Vera Cruz (Coordenador)

    Campinas

    Florentino de Araujo Cardoso Filho, MD

    Florentino de Araujo Cardoso Filho, MD

    Recruiting

  • Hospital São José

    Criciúma

    Felipe Dal Pizzol, MD

    Felipe Dal Pizzol, MD

    Recruiting

  • Hospital das Clínicas UFG

    Goiânia

    Daniela Graner Schuwartz Tannus Silva, MD

    Daniela Graner Schuwartz Tannus Silva, MD

    Not yet recruiting

  • Hospital Geral Prof. Dr. Waldemar de Carvalho Pinto Filho de Guarulhos - BR TRIALS

    Guarulhos

    Paulo Fernando Tierno, MD

    Paulo Fernando Tierno, MD

    Recruiting

  • Hospital Felício Rocho

    Horizonte

    Thaís de Paula Guimarães, MD

    Thaís de Paula Guimarães, MD

    Recruiting

  • Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho

    Jaú

    Patrícia Medeiros Milhomem Beato, MD

    Patrícia Medeiros Milhomem Beato, MD

    Recruiting

  • CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas

    Natal

    Kleber Giovanni Luz, MD

    Kleber Giovanni Luz, MD

    Recruiting

  • Hospital São Luiz de Jabaquara

    Porto Alegre

    Oscar Pereira Dutra, MD

    Oscar Pereira Dutra, MD

    Recruiting

  • Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre

    Cláudio Marcel Berdun Stadnik, MD

    Cláudio Marcel Berdun Stadnik, MD

    Recruiting

  • Hospital 9 de Julho

    São Paulo

    Celso Mitsushi Massumoto, MD

    Celso Mitsushi Massumoto, MD

    Recruiting

  • Hospital São Luiz de Jabaquara

    São Paulo

    Daniel Wagner de Castro Lima Santos, MD

    Not yet recruiting

  • Instituto de Moléstias Cardiovalsculares Tatuí Ltda

    Tatuí

    Wladmir Faustino Saporito, MD

    Wladmir Faustino Saporito, MD

    Recruiting

  • Lobus Centro de Pesquisa

    Volta Redonda

    Vicente Junior, MD

    Vicente Junior, MD

    Not yet recruiting

  • Lóbus Centro de Pesquisa Clínica

    Volta Redonda

    Vicente Lopes da Silva Júnior, MD

    Vicente Lopes da Silva Júnior, MD

    Recruiting

Other trials in Brazil

Turkey (Türkiye)12 sites, 12 recruiting

  • Ankara City Hospital

    Ankara

    Rahmet Guner, MD

    Recruiting

  • Hacettepe University Medical Faculty

    Ankara

    Serhat Unal, MD

    Recruiting

  • Dicle University, Medical Faculty

    Diyarbakır

    Mustafa Kemal Celen, MD

    Recruiting

  • Acibadem Atakent Hospital

    Istanbul

    Iftihar Koksal, MD

    Recruiting

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul

    Fehmi Tabak, MD

    Recruiting

  • Kartal Lutfi Kirdar Research and Training Hospital

    Istanbul

    Ayse Batirel, MD

    Recruiting

  • Ege University Medical Faculty

    Izmir

    Husnu Pullukcu, MD

    Recruiting

  • Kayseri City Hospital

    Kayseri

    Ilhami Celik, MD

    Recruiting

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli

    Sila Cetin Akhan, MD

    Recruiting

  • Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

    Konya

    Fikret Kanat, MD

    Recruiting

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun

    Ilkay Bozkurt

    Recruiting

  • Karadeniz Tecnical Uni. Med. Fac.

    Trabzon

    Firdevs Aksoy, MD

    Recruiting

Other trials in Turkey (Türkiye)

Ukraine12 sites, 12 recruiting

  • CI Dnipropetrovsk CCH #6 of DRC Dept of Therapy (with pulmonological beds) SI DMA of MoHU

    Dnipro

    Kseniia Bielosludtseva, MD

    Not yet recruiting

  • CNE CCH #16 of Dnipro City Council, DSMU, Ch of Intern Med #1

    Dnipro

    Tetiana Kirieieva, MD

    Not yet recruiting

  • CNE Ivano-Frankivsk Reg Clin Infectious Hospital of Ivano-Frankivsk Regional Council

    Ivano-Frankivsk

    Oleksandra Pryshliak, MD

    Not yet recruiting

  • CNE of Kharkov RC Reg Cl Infectious Hospital

    Kharkiv

    Anatoliy Gavrylov, MD

    Not yet recruiting

  • Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1"

    Kremenchuk

    Viktoriia Vypovska, MD

    Not yet recruiting

  • Kyiv Municipal Clinical Hospital #17 O. O. Bogomolets NMU

    Kyiv

    Sergii Dubrov, MD

    Not yet recruiting

  • City Hospital #1

    Mykolaiv

    Valeriy Molodtsov, MD

    Not yet recruiting

  • City Clinical infectious Hospital

    Odesa

    Svitlana Lavryukova, MD

    Not yet recruiting

  • Poltava Regional Clinical Infectious Hospital Dept of Diagnostics HSEIU Ukrainian Medical Stomatolog

    Poltava

    Tetiana Koval, MD

    Not yet recruiting

  • Municipal Non-Profit Enterprise Central City Hospital Of Rivne City Council

    Rivne

    Halyna Martynyuk, MD

    Not yet recruiting

  • CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases

    Vinnytsia

    Larysa Moroz, MD

    Not yet recruiting

  • CI Central City Hospital #1 of Zhytomyr

    Zhytomyr

    Ivan Vyshnyvetskyy, MD

    Not yet recruiting

Other trials in Ukraine

South Africa10 sites, 10 recruiting

  • Tiervlei Trial Centre

    Cape Town

    Matthys Basson, MD

    Recruiting

  • Tread Research

    Cape Town

    Lesley Burgess, MD

    Recruiting

  • Johese Clinical Research: Unitas

    Centurion

    Rani Elenjical, MD

    Recruiting

  • Drs Sarvan and Moodley

    Durban

    Mahomed Sarvan, MD

    Recruiting

  • TASK Eden

    George

    Kirsten McHarry, MD

    Recruiting

  • MERC SiReN

    Johannesburg

    Natasha Joseph, MD

    Recruiting

  • Nelson Mandela Academic Clinical Research Unit (NeMACRU)

    Mthatha

    Thozama Dubula, MD

    Recruiting

  • Into Research

    Pretoria

    Richard Siebert, MD

    Recruiting

  • Dr JM Engelbrecht Trial Site

    Somerset West

    Johannes Engelbrecht, MD

    Recruiting

  • Clinical Projects Research SA (PTY) LTD

    Worcester

    Louis van Zyl, MD

    Recruiting

Other trials in South Africa

Argentina9 sites, 9 recruiting

  • Hospital Interzonal General de Agudos Dr Jose Penna

    Bahía Blanca

    Ditondo Juan Carlos, MD

    Ditondo Juan Carlos, MD

    Recruiting

  • Clinica Zabala

    Buenos Aires

    Iastrebner Claudio Marcelo, MD

    Iastrebner Claudio Marcelo, MD

    Recruiting

  • CEMIC

    Ciudad Autonoma Buenos Aires

    Valentini Ricardo, MD

    Valentini Ricardo, MD

    Recruiting

  • Clinica Adventista Belgrano

    Ciudad Autonoma Buenos Aires

    Casas Marcelo Martin, MD

    Casas Marcelo Martin, MD

    Recruiting

  • Hospital San Roque

    Córdoba

    Parody Maria Leonor, MD

    Parody Maria Leonor, MD

    Recruiting

  • Sanatorio del Salvador Privado S.A.

    Córdoba

    Garcia Nestor Horacio, MD

    Garcia Nestor Horacio, MD

    Recruiting

  • Sanatorio Privado Duarte Quiroz De Clinica Colombo SA

    Córdoba

    Colombo Hugo, MD

    Colombo Hugo, MD

    Recruiting

  • Instituto Medico Rio Cuarto

    Río Cuarto

    D'Andrea Nores Ulises, MD

    D'Andrea Nores Ulises, MD

    Recruiting

  • Clinica Central S.A.

    Villa Regina

    Ariza Horacio Alberto, MD

    Ariza Horacio Alberto, MD

    Recruiting

Other trials in Argentina

Colombia6 sites, 6 recruiting

  • Clinica de la Costa Ltda

    Barranquilla

    Shirley Patricia Iglesias, MD

    Shirley Patricia Iglesias, MD

    Recruiting

  • Fundacion Hospital Universidad del Norte

    Barranquilla

    Hugo Macareno Arroyo, MD

    Hugo Macareno Arroyo, MD

    Recruiting

  • Fundacion Cardiovascular de Colombia - Instituto del Carazon Floridablanco

    Floridablanca, Santander Department

    Reyes Martinez, Carlos Fernando, MD

    Reyes Martinez, Carlos Fernando, MD

    Recruiting

  • Fundacion Oftalmologica

    Floridablanca

    Juan Diego Higuera Cobos, MD

    Juan Diego Higuera Cobos, MD

    Recruiting

  • Clinica SOMER

    Medellín

    Gomez Vega, Cristian Jose, MD

    Gomez Vega, Cristian Jose, MD

    Recruiting

  • Corporacion Clinica

    Villavicencio

    Franco Rodriguez, Adriana Paola, MD

    Franco Rodriguez, Adriana Paola, MD

    Recruiting

Other trials in Colombia

Kenya5 sites, 5 recruiting

  • KEMRI Kericho

    Kericho

    Isaac Tsikhutsu, MD

    Isaac Tsikhutsu, MD

    Not yet recruiting

  • KEMRI/CGHR Siaya Clinical Research Annexe

    Kisumu

    Kevin K Orimba, MD

    Kevin K Orimba, MD

    Not yet recruiting

  • Victoria Biomedical Research Institute

    Kisumu

    Lucas Otieno Tina, MD

    Lucas Otieno Tina, MD

    Recruiting

  • CREATES - Strathmore University Medical Centre

    Nairobi

    Bernhards Ogutu, MD

    Bernhards Ogutu, MD

    Recruiting

  • Kenyatta National Hospital

    Nairobi

    John Kinuthia, MD

    John Kinuthia, MD

    Not yet recruiting

Other trials in Kenya

Canada4 sites, 4 recruiting

  • University Hospital - London Health Sciences Centre

    London

    Sarah Shalhoub, MD

    Sarah Shalhoub

    Not yet recruiting

  • Victoria Hospital -London Health Sciences Centre

    London

    Sarah Shalhoub, MD

    Sarah Shalhoub, MD

    Not yet recruiting

  • St Paul's Hospital

    Vancouver

    John Boyd, MD

    John Boyd, MD

    Recruiting

  • St. Boniface Hospital

    Winnipeg

    Gloria Vazquez-Grande, MD

    Gloria Vazquez-Grande, MD

    Not yet recruiting

Other trials in Canada

Indonesia4 sites, 4 recruiting

  • RS Universitas Udayana

    Bali, 80361

    Wahyu Purnamasidhi Cokorda Agung, MD

    Wahyu Purnamasidhi Cokorda Agung, MD

    Not yet recruiting

  • Royal Taruma Hospital

    Jakarta

    Erni Juwita Nelwan, MD

    Erni Juwita Nelwan, MD

    Not yet recruiting

  • M. Djamil Hospital

    Padang

    Irvan Medison, MD

    Irvan Medison, MD

    Not yet recruiting

  • Sardjito Hospital

    Yogyakarta

    Harik Firman Thahadian, MD

    Harik Firman Thahadian, MD

    Not yet recruiting

Other trials in Indonesia

Malaysia4 sites, 4 recruiting

  • University Malaya Medical Centre

    Kuala Lumpur

    Sharifah Faridah Syed Omar, MD

    Sharifah Faridah Syed Omar, MD

    Recruiting

  • Hospital Miri

    Miri

    Ting Ingrid Pao Lin, MD

    Ting Ingrid Pao Lin, MD

    Recruiting

  • Sunway Medical Centre

    Petaling Jaya

    Kow Ken Siong, MD

    Kow Ken Siong, MD

    Recruiting

  • HPUPM

    Serdang

    Daut Ummi Nadira, MD

    Daut Ummi Nadira, MD

    Not yet recruiting

Other trials in Malaysia

Peru4 sites, 4 recruiting

  • Centro Medico Naval Cirujano Mayor Santiago Tavara

    Callao

    Emma Mercedes Huamani de la Cruz, MD

    Not yet recruiting

  • Hospital III Daniel Alcides Carrion - Red Essalud de Tacna

    Lima

    Miguel Hueda, MD

    Not yet recruiting

  • Hospital Nacional Dos de Mayo

    Lima

    Cesar Augusto Gamarra Ayarza, MD

    Not yet recruiting

  • Hospital Nacional Arzobispo Loayza

    Lima Cercado

    Zandra Moncada Vilela, MD

    Not yet recruiting

Other trials in Peru

Chile2 sites, 1 recruiting

  • Hospital Base Osorno

    Osorno

    Bernardo Goecke Hochberger, MD

    Bernardo Goecke Hochberger, MD

    Recruiting

  • Hospital Sotero del Rio

    Santiago

    Withdrawn

Other trials in Chile

About this study

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

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
Conditions
Covid19
Being tested
Novaferon, Placebo
Keywords
antiviral, SARS-CoV-2, COVID19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovaferonBiological

    Also called Standard of Care

    a novel recombinant antiviral protein drug

  • PlaceboBiological

    Also called Standard of Care

    Formulation vehicle

Study groups in NCT04669015
Study groupRoleWhat they receive
Active plus SOCExperimentalInhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care
Receives: Biological: Novaferon
Placebo plus SOCPlacebo comparatorInhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of clinical deterioration

    Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8)

    Measured: From enrollment to Day 28

Secondary outcomes (5)

  1. Rate of recovery

    Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3)

    Measured: From enrollment to Day 28

  2. Hospital discharge rate

    Rate of non-hospitalized alive patients

    Measured: At Day 28

  3. Mortality rate

    Mortality rate

    Measured: At Day 28

  4. Duration of hospitalization

    Number of days hospitalized

    Measured: Up to Day 28

  5. Adverse events

    Adverse event incidence, type and severity

    Measured: From first dose to Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start10 Jun 2021
  3. Primary completionAug 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
914 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04669015
Sponsor's protocol ID
JH-COR-003
Acronym
NOVATION-1
Status last verified
Jun 2022
First submitted
14 Dec 2020
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Novaferon in people with Covid19, run by Genova Inc. at 88 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in Brazil, Turkey (Türkiye), Ukraine, South Africa, Argentina and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huimei Huang (+6582027938, hhuang@genova.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of clinical deterioration (time frame: From enrollment to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.

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