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Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

Primary Purpose

Covid19, SARS (Severe Acute Respiratory Syndrome), SARS Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fostamatinib
Placebo
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, SARS-Associated Coronavirus Pneumonia, Pneumonia, Viral

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥18 years of age at screening.
  • The subject or a legally authorized representative has provided written informed consent.
  • Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs.
  • Male or non-pregnant, non-lactating female subjects with SARS-CoV-2 infection documented by a hospital approved diagnostic test (eg, a Food and Drug Administration authorized test in the US) within 7 days prior to randomization.

Exclusion Criteria:

  • Pregnant or lactating female of childbearing potential.
  • Use of extracorporeal membrane oxygenation (ECMO).
  • Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg and/or diastolic BP ≥100 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment at screening.
  • History of myocardial infarction within 1 month prior to screening.

Sites / Locations

  • University of California Irvine
  • George Washington University Hospital
  • Alternative Research Associates, LLC
  • Alternative Research Associates, LLC
  • Loyola University Medical School
  • Harvard Medical School- Bringham and Women's Hospital
  • Henry Ford
  • Ascension Medical Group- St. John Clinic Infectious Disease
  • Houston Methodist Research Institute
  • Clinica Chutro
  • Hospital Lencinas
  • Corporacion Medica de General San Martin
  • Hospital de Alta Complejidad Cuenta Alta
  • Hospital Del Bicentenario - Dr. Luis Federico Leloir
  • Clinica Zabala
  • Clinica Adventista Belgrano
  • Clinica Monte Grande
  • Hospital de Infecciosas Dr.Francisco Javier Muñiz
  • Sanatorio Guemes
  • Sanatorio Sagrado Corazon
  • Hospital San Roque
  • Sanatorio Mayo Privado
  • Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG)
  • Hospital Luxenburgo-Associação Mário Penna
  • Hospital Universitario de Maringa
  • Hosp. Angelina Caron
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
  • Hospital des clinicas de porto alegre - Centro de pequisas clinicas
  • Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA
  • Hospital Alemão Oswaldo Cruz (HAOC)
  • Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)
  • Hospital Bandeirantes (LeForte)
  • Hospital Universitário São Francisco na Providência de Deus
  • Clinica de Alergia Martti Antila S/S Ltda
  • Fundação Faculdade Reg. de Med de SJRP
  • Star Medica Vivo Bicentenario
  • Unidad Medica para la Salud Integral (UMSI)
  • Köhler & Milstein Research
  • Hospital Cardiologica Aguascalientes
  • Icaro Investigaciones en Medicina
  • Nuevo Hospital Civil de Guadalajara
  • Centro Medico Issemym Toluca
  • The American British Cowdray Medical Center I.A.P.
  • Hospital Ángeles Roma
  • CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
  • Hospital Civil de Culiacan
  • Hospital Civil de Culiacan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fostamatinib (150 mg twice daily for 14 days) + Standard of Care

Placebo (twice daily for 14 days) + Standard of Care

Arm Description

Fostamatinib (150 mg twice daily for 14 days) + Standard of Care

Placebo (twice daily for 14 days) + Standard of Care

Outcomes

Primary Outcome Measures

Number of days on oxygen from randomization on Day 1 to Day 29
Number of days on oxygen from randomization on Day 1 to Day 29

Secondary Outcome Measures

Mean change from baseline over time in clinical status score using the 8-point ordinal scale, to the average from Day 5 through Day 15.
Mean change from baseline over time in clinical status score using the 8-point ordinal
Number of days in the ICU from randomization on Day 1 to Day 29
Number of days in the ICU from randomization on Day 1 to Day 29
Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).
Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).
All-cause mortality by Day 29.
All-cause mortality by Day 29.
All-cause mortality by Day 60
All-cause mortality by Day 60
Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Proportion of subjects alive by Day 60 and oxygen free on Day 29
Proportion of subjects alive by Day 60 and oxygen free on Day 29

Full Information

First Posted
November 13, 2020
Last Updated
August 15, 2023
Sponsor
Rigel Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04629703
Brief Title
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Official Title
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

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

5. Study Description

Brief Summary
The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.
Detailed Description
The primary objective of this study is: To evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by days on oxygen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS (Severe Acute Respiratory Syndrome), SARS Pneumonia, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Pneumonia, Pneumonia, Viral
Keywords
COVID19, SARS-Associated Coronavirus Pneumonia, Pneumonia, Viral

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
Arm Type
Active Comparator
Arm Description
Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
Arm Title
Placebo (twice daily for 14 days) + Standard of Care
Arm Type
Placebo Comparator
Arm Description
Placebo (twice daily for 14 days) + Standard of Care
Intervention Type
Drug
Intervention Name(s)
Fostamatinib
Other Intervention Name(s)
Fostamatinib disodium
Intervention Description
Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (twice daily) for 14 days and Standard of Care
Primary Outcome Measure Information:
Title
Number of days on oxygen from randomization on Day 1 to Day 29
Description
Number of days on oxygen from randomization on Day 1 to Day 29
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Mean change from baseline over time in clinical status score using the 8-point ordinal scale, to the average from Day 5 through Day 15.
Description
Mean change from baseline over time in clinical status score using the 8-point ordinal
Time Frame
10 days
Title
Number of days in the ICU from randomization on Day 1 to Day 29
Description
Number of days in the ICU from randomization on Day 1 to Day 29
Time Frame
29 days
Title
Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).
Description
Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).
Time Frame
29 days
Title
All-cause mortality by Day 29.
Description
All-cause mortality by Day 29.
Time Frame
29 days
Title
All-cause mortality by Day 60
Description
All-cause mortality by Day 60
Time Frame
60 days
Title
Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Description
Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Time Frame
29 days
Title
Proportion of subjects alive by Day 60 and oxygen free on Day 29
Description
Proportion of subjects alive by Day 60 and oxygen free on Day 29
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years of age at screening. The subject or a legally authorized representative has provided written informed consent. Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs. Male or non-pregnant, non-lactating female subjects with SARS-CoV-2 infection documented by a hospital approved diagnostic test (eg, a Food and Drug Administration authorized test in the US) within 7 days prior to randomization. Exclusion Criteria: Pregnant or lactating female of childbearing potential. Use of extracorporeal membrane oxygenation (ECMO). Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg and/or diastolic BP ≥100 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment at screening. History of myocardial infarction within 1 month prior to screening.
Facility Information:
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Alternative Research Associates, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Alternative Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Loyola University Medical School
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60600
Country
United States
Facility Name
Harvard Medical School- Bringham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Henry Ford
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Ascension Medical Group- St. John Clinic Infectious Disease
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74101
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinica Chutro
City
Cordoba
State/Province
CP
ZIP/Postal Code
EPU5000
Country
Argentina
Facility Name
Hospital Lencinas
City
Godoy Cruz
State/Province
Mendoza
ZIP/Postal Code
PC: 5547
Country
Argentina
Facility Name
Corporacion Medica de General San Martin
City
San Martin
State/Province
Provincia De Buenos Aires
ZIP/Postal Code
CP 1650
Country
Argentina
Facility Name
Hospital de Alta Complejidad Cuenta Alta
City
Buenos Aires
ZIP/Postal Code
B1814
Country
Argentina
Facility Name
Hospital Del Bicentenario - Dr. Luis Federico Leloir
City
Buenos Aires
ZIP/Postal Code
B1842
Country
Argentina
Facility Name
Clinica Zabala
City
Buenos Aires
ZIP/Postal Code
C1426
Country
Argentina
Facility Name
Clinica Adventista Belgrano
City
Buenos Aires
Country
Argentina
Facility Name
Clinica Monte Grande
City
Buenos Aires
Country
Argentina
Facility Name
Hospital de Infecciosas Dr.Francisco Javier Muñiz
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Guemes
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Sagrado Corazon
City
Buenos Aires
Country
Argentina
Facility Name
Hospital San Roque
City
Córdoba
Country
Argentina
Facility Name
Sanatorio Mayo Privado
City
Córdoba
Country
Argentina
Facility Name
Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG)
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74605
Country
Brazil
Facility Name
Hospital Luxenburgo-Associação Mário Penna
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30380
Country
Brazil
Facility Name
Hospital Universitario de Maringa
City
Maringá
State/Province
Parana
ZIP/Postal Code
87083
Country
Brazil
Facility Name
Hosp. Angelina Caron
City
Campina Grande do Sul
State/Province
Paraná
ZIP/Postal Code
83430-000
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020
Country
Brazil
Facility Name
Hospital des clinicas de porto alegre - Centro de pequisas clinicas
City
Porto Alegre,
State/Province
RS
ZIP/Postal Code
90035 - 903
Country
Brazil
Facility Name
Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89030
Country
Brazil
Facility Name
Hospital Alemão Oswaldo Cruz (HAOC)
City
Bela Vista
State/Province
Sao Paolo
ZIP/Postal Code
01323
Country
Brazil
Facility Name
Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)
City
Campinas
State/Province
Sao Paolo
ZIP/Postal Code
13060
Country
Brazil
Facility Name
Hospital Bandeirantes (LeForte)
City
Liberdade
State/Province
Sao Paolo
ZIP/Postal Code
01506
Country
Brazil
Facility Name
Hospital Universitário São Francisco na Providência de Deus
City
Braganca Paulista
State/Province
Sao Paulo
ZIP/Postal Code
12916-542
Country
Brazil
Facility Name
Clinica de Alergia Martti Antila S/S Ltda
City
Sorocaba
State/Province
Sao Paulo
ZIP/Postal Code
18040
Country
Brazil
Facility Name
Fundação Faculdade Reg. de Med de SJRP
City
São José Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090
Country
Brazil
Facility Name
Star Medica Vivo Bicentenario
City
Nezahualcóyotl
State/Province
Mex
ZIP/Postal Code
57205
Country
Mexico
Facility Name
Unidad Medica para la Salud Integral (UMSI)
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Köhler & Milstein Research
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Hospital Cardiologica Aguascalientes
City
Aguascalientes
Country
Mexico
Facility Name
Icaro Investigaciones en Medicina
City
Chihuahua
ZIP/Postal Code
CP:3100
Country
Mexico
Facility Name
Nuevo Hospital Civil de Guadalajara
City
Guadalajara
Country
Mexico
Facility Name
Centro Medico Issemym Toluca
City
Metepec
Country
Mexico
Facility Name
The American British Cowdray Medical Center I.A.P.
City
Mexico City
Country
Mexico
Facility Name
Hospital Ángeles Roma
City
Mexico
Country
Mexico
Facility Name
CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
City
Nuevo León
Country
Mexico
Facility Name
Hospital Civil de Culiacan
City
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Hospital Civil de Culiacan
City
Sinaloa
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived

Learn more about this trial

Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

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