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Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19 (NOVATION-1)

Primary Purpose

Covid19

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Novaferon
Placebo
Sponsored by
Genova Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring antiviral, SARS-CoV-2, COVID19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Interzonal General de Agudos Dr Jose PennaRecruiting
  • CEMICRecruiting
  • Clinica Adventista BelgranoRecruiting
  • Clinica ZabalaRecruiting
  • Hospital San RoqueRecruiting
  • Sanatorio del Salvador Privado S.A.Recruiting
  • Sanatorio Privado Duarte Quiroz De Clinica Colombo SARecruiting
  • Instituto Medico Rio CuartoRecruiting
  • Clinica Central S.A.Recruiting
  • HCPA- Hospital de Clínicas de Porto AlegreRecruiting
  • Fundação PIO XII Hospital de Amor de BarretosRecruiting
  • Hospital Casa de Saúde Vera Cruz (Coordenador)Recruiting
  • Hospital São JoséRecruiting
  • Hospital das Clínicas UFG
  • Hospital Geral Prof. Dr. Waldemar de Carvalho Pinto Filho de Guarulhos - BR TRIALSRecruiting
  • Hospital Felício RochoRecruiting
  • Centro de Pesquisas Clínicas da Fundação Doutor Amaral CarvalhoRecruiting
  • CePCLIN - Centro de Estudos e Pesquisas em Moléstias InfecciosasRecruiting
  • Hospital São Luiz de JabaquaraRecruiting
  • Santa Casa de Misericórdia de Porto AlegreRecruiting
  • Hospital 9 de JulhoRecruiting
  • Hospital São Luiz de Jabaquara
  • Instituto de Moléstias Cardiovalsculares Tatuí LtdaRecruiting
  • Lobus Centro de Pesquisa
  • Lóbus Centro de Pesquisa ClínicaRecruiting
  • University Hospital - London Health Sciences Centre
  • Victoria Hospital -London Health Sciences Centre
  • St Paul's HospitalRecruiting
  • St. Boniface Hospital
  • Hospital Base OsornoRecruiting
  • Hospital Sotero del Rio
  • Fundacion Cardiovascular de Colombia - Instituto del Carazon FloridablancoRecruiting
  • Clinica de la Costa LtdaRecruiting
  • Fundacion Hospital Universidad del NorteRecruiting
  • Fundacion OftalmologicaRecruiting
  • Clinica SOMERRecruiting
  • Corporacion ClinicaRecruiting
  • RS Universitas Udayana
  • Royal Taruma Hospital
  • M. Djamil Hospital
  • Sardjito Hospital
  • KEMRI Kericho
  • KEMRI/CGHR Siaya Clinical Research Annexe
  • Victoria Biomedical Research InstituteRecruiting
  • CREATES - Strathmore University Medical CentreRecruiting
  • Kenyatta National Hospital
  • University Malaya Medical CentreRecruiting
  • Hospital MiriRecruiting
  • Sunway Medical CentreRecruiting
  • HPUPM
  • Centro Medico Naval Cirujano Mayor Santiago Tavara
  • Hospital Nacional Arzobispo Loayza
  • Hospital III Daniel Alcides Carrion - Red Essalud de Tacna
  • Hospital Nacional Dos de Mayo
  • Tiervlei Trial CentreRecruiting
  • Tread ResearchRecruiting
  • Johese Clinical Research: UnitasRecruiting
  • Drs Sarvan and MoodleyRecruiting
  • TASK EdenRecruiting
  • MERC SiReNRecruiting
  • Nelson Mandela Academic Clinical Research Unit (NeMACRU)Recruiting
  • Into ResearchRecruiting
  • Dr JM Engelbrecht Trial SiteRecruiting
  • Clinical Projects Research SA (PTY) LTDRecruiting
  • Ankara City HospitalRecruiting
  • Hacettepe University Medical FacultyRecruiting
  • Dicle University, Medical FacultyRecruiting
  • Acibadem Atakent HospitalRecruiting
  • Istanbul University Cerrahpasa - Cerrahpasa Medical FacultyRecruiting
  • Kartal Lutfi Kirdar Research and Training HospitalRecruiting
  • Ege University Medical FacultyRecruiting
  • Kayseri City HospitalRecruiting
  • Kocaeli Universitesi Tip FakultesiRecruiting
  • Selcuk Universitesi Selcuklu Tip Fakultesi HastanesiRecruiting
  • Ondokuz Mayis Univ. Med. Fac.Recruiting
  • Karadeniz Tecnical Uni. Med. Fac.Recruiting
  • CI Dnipropetrovsk CCH #6 of DRC Dept of Therapy (with pulmonological beds) SI DMA of MoHU
  • CNE CCH #16 of Dnipro City Council, DSMU, Ch of Intern Med #1
  • CNE Ivano-Frankivsk Reg Clin Infectious Hospital of Ivano-Frankivsk Regional Council
  • CNE of Kharkov RC Reg Cl Infectious Hospital
  • Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1"
  • Kyiv Municipal Clinical Hospital #17 O. O. Bogomolets NMU
  • City Hospital #1
  • City Clinical infectious Hospital
  • Poltava Regional Clinical Infectious Hospital Dept of Diagnostics HSEIU Ukrainian Medical Stomatolog
  • Municipal Non-Profit Enterprise Central City Hospital Of Rivne City Council
  • CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases
  • CI Central City Hospital #1 of Zhytomyr

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active plus SOC

Placebo plus SOC

Arm Description

Inhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care

Inhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of recovery
Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3)
Hospital discharge rate
Rate of non-hospitalized alive patients
Mortality rate
Mortality rate
Duration of hospitalization
Number of days hospitalized
Adverse events
Adverse event incidence, type and severity

Full Information

First Posted
December 14, 2020
Last Updated
June 1, 2022
Sponsor
Genova Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04669015
Brief Title
Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genova Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
antiviral, SARS-CoV-2, COVID19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
914 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active plus SOC
Arm Type
Experimental
Arm Description
Inhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care
Arm Title
Placebo plus SOC
Arm Type
Placebo Comparator
Arm Description
Inhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care
Intervention Type
Biological
Intervention Name(s)
Novaferon
Other Intervention Name(s)
Standard of Care
Intervention Description
a novel recombinant antiviral protein drug
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Standard of Care
Intervention Description
Formulation vehicle
Primary Outcome Measure Information:
Title
Rate of clinical deterioration
Description
Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8)
Time Frame
From enrollment to Day 28
Secondary Outcome Measure Information:
Title
Rate of recovery
Description
Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3)
Time Frame
From enrollment to Day 28
Title
Hospital discharge rate
Description
Rate of non-hospitalized alive patients
Time Frame
At Day 28
Title
Mortality rate
Description
Mortality rate
Time Frame
At Day 28
Title
Duration of hospitalization
Description
Number of days hospitalized
Time Frame
Up to Day 28
Title
Adverse events
Description
Adverse event incidence, type and severity
Time Frame
From first dose to Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huimei Huang
Phone
+6582027938
Email
hhuang@genova.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Joyce
Phone
(1 604) 306 6003
Email
JOYCE <jwy8890@gmail.com>
Facility Information:
Facility Name
Hospital Interzonal General de Agudos Dr Jose Penna
City
Bahia Blanca
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ditondo Juan Carlos, MD
First Name & Middle Initial & Last Name & Degree
Ditondo Juan Carlos, MD
Facility Name
CEMIC
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentini Ricardo, MD
First Name & Middle Initial & Last Name & Degree
Valentini Ricardo, MD
Facility Name
Clinica Adventista Belgrano
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casas Marcelo Martin, MD
First Name & Middle Initial & Last Name & Degree
Casas Marcelo Martin, MD
Facility Name
Clinica Zabala
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iastrebner Claudio Marcelo, MD
First Name & Middle Initial & Last Name & Degree
Iastrebner Claudio Marcelo, MD
Facility Name
Hospital San Roque
City
Cordoba
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parody Maria Leonor, MD
First Name & Middle Initial & Last Name & Degree
Parody Maria Leonor, MD
Facility Name
Sanatorio del Salvador Privado S.A.
City
Cordoba
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garcia Nestor Horacio, MD
First Name & Middle Initial & Last Name & Degree
Garcia Nestor Horacio, MD
Facility Name
Sanatorio Privado Duarte Quiroz De Clinica Colombo SA
City
Cordoba
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colombo Hugo, MD
First Name & Middle Initial & Last Name & Degree
Colombo Hugo, MD
Facility Name
Instituto Medico Rio Cuarto
City
Rio Cuarto
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D'Andrea Nores Ulises, MD
First Name & Middle Initial & Last Name & Degree
D'Andrea Nores Ulises, MD
Facility Name
Clinica Central S.A.
City
Villa Regina
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariza Horacio Alberto, MD
First Name & Middle Initial & Last Name & Degree
Ariza Horacio Alberto, MD
Facility Name
HCPA- Hospital de Clínicas de Porto Alegre
City
Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Sprinz, MD
First Name & Middle Initial & Last Name & Degree
Eduardo Sprinz, MD
Facility Name
Fundação PIO XII Hospital de Amor de Barretos
City
Barretos
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Mauricio da Silva, MD
First Name & Middle Initial & Last Name & Degree
Cesar Mauricio da Silva, MD
Facility Name
Hospital Casa de Saúde Vera Cruz (Coordenador)
City
Campinas
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florentino de Araujo Cardoso Filho, MD
First Name & Middle Initial & Last Name & Degree
Florentino de Araujo Cardoso Filho, MD
Facility Name
Hospital São José
City
Criciúma
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Dal Pizzol, MD
First Name & Middle Initial & Last Name & Degree
Felipe Dal Pizzol, MD
Facility Name
Hospital das Clínicas UFG
City
Goiânia
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Graner Schuwartz Tannus Silva, MD
First Name & Middle Initial & Last Name & Degree
Daniela Graner Schuwartz Tannus Silva, MD
Facility Name
Hospital Geral Prof. Dr. Waldemar de Carvalho Pinto Filho de Guarulhos - BR TRIALS
City
Guarulhos
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo Fernando Tierno, MD
First Name & Middle Initial & Last Name & Degree
Paulo Fernando Tierno, MD
Facility Name
Hospital Felício Rocho
City
Horizonte
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thaís de Paula Guimarães, MD
First Name & Middle Initial & Last Name & Degree
Thaís de Paula Guimarães, MD
Facility Name
Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho
City
Jaú
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrícia Medeiros Milhomem Beato, MD
First Name & Middle Initial & Last Name & Degree
Patrícia Medeiros Milhomem Beato, MD
Facility Name
CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas
City
Natal
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kleber Giovanni Luz, MD
First Name & Middle Initial & Last Name & Degree
Kleber Giovanni Luz, MD
Facility Name
Hospital São Luiz de Jabaquara
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Pereira Dutra, MD
First Name & Middle Initial & Last Name & Degree
Oscar Pereira Dutra, MD
Facility Name
Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cláudio Marcel Berdun Stadnik, MD
First Name & Middle Initial & Last Name & Degree
Cláudio Marcel Berdun Stadnik, MD
Facility Name
Hospital 9 de Julho
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celso Mitsushi Massumoto, MD
First Name & Middle Initial & Last Name & Degree
Celso Mitsushi Massumoto, MD
Facility Name
Hospital São Luiz de Jabaquara
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Wagner de Castro Lima Santos, MD
Facility Name
Instituto de Moléstias Cardiovalsculares Tatuí Ltda
City
Tatuí
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wladmir Faustino Saporito, MD
First Name & Middle Initial & Last Name & Degree
Wladmir Faustino Saporito, MD
Facility Name
Lobus Centro de Pesquisa
City
Volta Redonda
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Junior, MD
First Name & Middle Initial & Last Name & Degree
Vicente Junior, MD
Facility Name
Lóbus Centro de Pesquisa Clínica
City
Volta Redonda
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Lopes da Silva Júnior, MD
First Name & Middle Initial & Last Name & Degree
Vicente Lopes da Silva Júnior, MD
Facility Name
University Hospital - London Health Sciences Centre
City
London
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Shalhoub, MD
First Name & Middle Initial & Last Name & Degree
Sarah Shalhoub
Facility Name
Victoria Hospital -London Health Sciences Centre
City
London
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Shalhoub, MD
First Name & Middle Initial & Last Name & Degree
Sarah Shalhoub, MD
Facility Name
St Paul's Hospital
City
Vancouver
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Boyd, MD
First Name & Middle Initial & Last Name & Degree
John Boyd, MD
Facility Name
St. Boniface Hospital
City
Winnipeg
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Vazquez-Grande, MD
First Name & Middle Initial & Last Name & Degree
Gloria Vazquez-Grande, MD
Facility Name
Hospital Base Osorno
City
Osorno
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardo Goecke Hochberger, MD
First Name & Middle Initial & Last Name & Degree
Bernardo Goecke Hochberger, MD
Facility Name
Hospital Sotero del Rio
City
Santiago
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Fundacion Cardiovascular de Colombia - Instituto del Carazon Floridablanco
City
Floridablanca
State/Province
Santander
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reyes Martinez, Carlos Fernando, MD
First Name & Middle Initial & Last Name & Degree
Reyes Martinez, Carlos Fernando, MD
Facility Name
Clinica de la Costa Ltda
City
Barranquilla
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Patricia Iglesias, MD
First Name & Middle Initial & Last Name & Degree
Shirley Patricia Iglesias, MD
Facility Name
Fundacion Hospital Universidad del Norte
City
Barranquilla
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Macareno Arroyo, MD
First Name & Middle Initial & Last Name & Degree
Hugo Macareno Arroyo, MD
Facility Name
Fundacion Oftalmologica
City
Floridablanca
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Diego Higuera Cobos, MD
First Name & Middle Initial & Last Name & Degree
Juan Diego Higuera Cobos, MD
Facility Name
Clinica SOMER
City
Medellín
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gomez Vega, Cristian Jose, MD
First Name & Middle Initial & Last Name & Degree
Gomez Vega, Cristian Jose, MD
Facility Name
Corporacion Clinica
City
Villavicencio
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Rodriguez, Adriana Paola, MD
First Name & Middle Initial & Last Name & Degree
Franco Rodriguez, Adriana Paola, MD
Facility Name
RS Universitas Udayana
City
Bali
ZIP/Postal Code
80361
Country
Indonesia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wahyu Purnamasidhi Cokorda Agung, MD
First Name & Middle Initial & Last Name & Degree
Wahyu Purnamasidhi Cokorda Agung, MD
Facility Name
Royal Taruma Hospital
City
Jakarta
Country
Indonesia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erni Juwita Nelwan, MD
First Name & Middle Initial & Last Name & Degree
Erni Juwita Nelwan, MD
Facility Name
M. Djamil Hospital
City
Padang
Country
Indonesia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irvan Medison, MD
First Name & Middle Initial & Last Name & Degree
Irvan Medison, MD
Facility Name
Sardjito Hospital
City
Yogyakarta
Country
Indonesia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harik Firman Thahadian, MD
First Name & Middle Initial & Last Name & Degree
Harik Firman Thahadian, MD
Facility Name
KEMRI Kericho
City
Kericho
Country
Kenya
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isaac Tsikhutsu, MD
First Name & Middle Initial & Last Name & Degree
Isaac Tsikhutsu, MD
Facility Name
KEMRI/CGHR Siaya Clinical Research Annexe
City
Kisumu
Country
Kenya
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin K Orimba, MD
First Name & Middle Initial & Last Name & Degree
Kevin K Orimba, MD
Facility Name
Victoria Biomedical Research Institute
City
Kisumu
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Otieno Tina, MD
First Name & Middle Initial & Last Name & Degree
Lucas Otieno Tina, MD
Facility Name
CREATES - Strathmore University Medical Centre
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhards Ogutu, MD
First Name & Middle Initial & Last Name & Degree
Bernhards Ogutu, MD
Facility Name
Kenyatta National Hospital
City
Nairobi
Country
Kenya
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MD
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MD
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharifah Faridah Syed Omar, MD
First Name & Middle Initial & Last Name & Degree
Sharifah Faridah Syed Omar, MD
Facility Name
Hospital Miri
City
Miri
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Ingrid Pao Lin, MD
First Name & Middle Initial & Last Name & Degree
Ting Ingrid Pao Lin, MD
Facility Name
Sunway Medical Centre
City
Petaling Jaya
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kow Ken Siong, MD
First Name & Middle Initial & Last Name & Degree
Kow Ken Siong, MD
Facility Name
HPUPM
City
Serdang
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daut Ummi Nadira, MD
First Name & Middle Initial & Last Name & Degree
Daut Ummi Nadira, MD
Facility Name
Centro Medico Naval Cirujano Mayor Santiago Tavara
City
Callao
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Mercedes Huamani de la Cruz, MD
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima Cercado
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zandra Moncada Vilela, MD
Facility Name
Hospital III Daniel Alcides Carrion - Red Essalud de Tacna
City
Lima
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Hueda, MD
Facility Name
Hospital Nacional Dos de Mayo
City
Lima
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Augusto Gamarra Ayarza, MD
Facility Name
Tiervlei Trial Centre
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthys Basson, MD
Facility Name
Tread Research
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesley Burgess, MD
Facility Name
Johese Clinical Research: Unitas
City
Centurion
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rani Elenjical, MD
Facility Name
Drs Sarvan and Moodley
City
Durban
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahomed Sarvan, MD
Facility Name
TASK Eden
City
George
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten McHarry, MD
Facility Name
MERC SiReN
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Joseph, MD
Facility Name
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
City
Mthatha
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thozama Dubula, MD
Facility Name
Into Research
City
Pretoria
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Siebert, MD
Facility Name
Dr JM Engelbrecht Trial Site
City
Somerset West
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Engelbrecht, MD
Facility Name
Clinical Projects Research SA (PTY) LTD
City
Worcester
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis van Zyl, MD
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahmet Guner, MD
Facility Name
Hacettepe University Medical Faculty
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serhat Unal, MD
Facility Name
Dicle University, Medical Faculty
City
Diyarbakir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Kemal Celen, MD
Facility Name
Acibadem Atakent Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iftihar Koksal, MD
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fehmi Tabak, MD
Facility Name
Kartal Lutfi Kirdar Research and Training Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayse Batirel, MD
Facility Name
Ege University Medical Faculty
City
Izmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Husnu Pullukcu, MD
Facility Name
Kayseri City Hospital
City
Kayseri
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilhami Celik, MD
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sila Cetin Akhan, MD
Facility Name
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
City
Konya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fikret Kanat, MD
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilkay Bozkurt
Facility Name
Karadeniz Tecnical Uni. Med. Fac.
City
Trabzon
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firdevs Aksoy, MD
Facility Name
CI Dnipropetrovsk CCH #6 of DRC Dept of Therapy (with pulmonological beds) SI DMA of MoHU
City
Dnipro
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kseniia Bielosludtseva, MD
Facility Name
CNE CCH #16 of Dnipro City Council, DSMU, Ch of Intern Med #1
City
Dnipro
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetiana Kirieieva, MD
Facility Name
CNE Ivano-Frankivsk Reg Clin Infectious Hospital of Ivano-Frankivsk Regional Council
City
Ivano-Frankivsk
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oleksandra Pryshliak, MD
Facility Name
CNE of Kharkov RC Reg Cl Infectious Hospital
City
Kharkiv
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anatoliy Gavrylov, MD
Facility Name
Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1"
City
Kremenchuk
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viktoriia Vypovska, MD
Facility Name
Kyiv Municipal Clinical Hospital #17 O. O. Bogomolets NMU
City
Kyiv
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergii Dubrov, MD
Facility Name
City Hospital #1
City
Mykolaiv
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeriy Molodtsov, MD
Facility Name
City Clinical infectious Hospital
City
Odesa
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svitlana Lavryukova, MD
Facility Name
Poltava Regional Clinical Infectious Hospital Dept of Diagnostics HSEIU Ukrainian Medical Stomatolog
City
Poltava
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetiana Koval, MD
Facility Name
Municipal Non-Profit Enterprise Central City Hospital Of Rivne City Council
City
Rivne
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halyna Martynyuk, MD
Facility Name
CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases
City
Vinnytsia
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larysa Moroz, MD
Facility Name
CI Central City Hospital #1 of Zhytomyr
City
Zhytomyr
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Vyshnyvetskyy, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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