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

June 1, 2022 updated by: Genova Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

914

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active plus SOC
Inhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care
Biological: Novaferon
a novel recombinant antiviral protein drug
Other Names:
  • Standard of Care
Placebo Comparator: Placebo plus SOC
Inhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care
Biological: Placebo
Formulation vehicle
Other Names:
  • Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinical deterioration
Time Frame: From enrollment to Day 28
Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8)
From enrollment to Day 28

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genova Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JH-COR-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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