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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Viral; Pneumonia; Covid19; SARS (Severe Acute Respiratory Syndrome); SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; SARS Pneumonia
• Intervention / Treatment: Drug: Fostamatinib; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Sanatorio Güemes
  • Buenos Aires, Argentina, B1814
    • Hospital de Alta Complejidad Cuenta Alta
  • Buenos Aires, Argentina, B1842
    • Hospital Del Bicentenario - Dr. Luis Federico Leloir
  • Buenos Aires, Argentina, C1426
    • Clínica Zabala
  • Buenos Aires, Argentina
    • Clinica Adventista Belgrano
  • Buenos Aires, Argentina
    • Clinica Monte Grande
  • Buenos Aires, Argentina
    • Hospital de Infecciosas Dr.Francisco Javier Muñiz
  • Buenos Aires, Argentina
    • Sanatorio Sagrado Corazon
  • Córdoba, Argentina
    • Hospital San Roque
  • Córdoba, Argentina
    • Sanatorio Mayo Privado
  • CP
    • Cordoba, CP, Argentina, EPU5000
      • Clínica Chutro
  • Mendoza
    • Godoy Cruz, Mendoza, Argentina, PC: 5547
      • Hospital Lencinas
  • Provincia De Buenos Aires
    • San Martin, Provincia De Buenos Aires, Argentina, CP 1650
      • Corporación Médica de General San Martín
• Brazil
  • Goiás
    • Goiânia, Goiás, Brazil, 74605
      • Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG)
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30380
      • Hospital Luxenburgo-Associação Mário Penna
  • Parana
    • Maringá, Parana, Brazil, 87083
      • Hospital Universitário de Maringá
  • Paraná
    • Campina Grande do Sul, Paraná, Brazil, 83430-000
      • Hosp. Angelina Caron
  • RS
    • Porto Alegre,, RS, Brazil, 90035 - 903
      • Hospital des clinicas de porto alegre - Centro de pequisas clinicas
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89030
      • Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA
  • Sao Paolo
    • Bela Vista, Sao Paolo, Brazil, 01323
      • Hospital Alemao Oswaldo Cruz (HAOC)
    • Campinas, Sao Paolo, Brazil, 13060
      • Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)
    • Liberdade, Sao Paolo, Brazil, 01506
      • Hospital Bandeirantes (LeForte)
  • Sao Paulo
    • Braganca Paulista, Sao Paulo, Brazil, 12916-542
      • Hospital Universitario Sao Francisco na Providencia de Deus
    • Sorocaba, Sao Paulo, Brazil, 18040
      • Clinica de Alergia Martti Antila S/S Ltda
    • São José Do Rio Preto, Sao Paulo, Brazil, 15090
      • Fundação Faculdade Reg. de Med de SJRP
• Mexico
  • Aguascalientes, Mexico
    • Hospital Cardiologica Aguascalientes
  • Chihuahua, Mexico, CP:3100
    • Icaro Investigaciones en Medicina
  • Guadalajara, Mexico
    • Nuevo Hospital Civil de Guadalajara
  • Metepec, Mexico
    • Centro Medico Issemym Toluca
  • Mexico, Mexico
    • Hospital Ángeles Roma
  • Mexico City, Mexico
    • The American British Cowdray Medical Center I.A.P.
  • Nuevo León, Mexico
    • CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
  • Sinaloa, Mexico, 80230
    • Hospital Civil de Culiacan
  • Sinaloa, Mexico
    • Hospital Civil de Culiacan
  • Mex
    • Nezahualcóyotl, Mex, Mexico, 57205
      • Star Medica Vivo Bicentenario
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico
      • Unidad Medica para la Salud Integral (UMSI)
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Köhler & Milstein Research
• United States
  • California
    • Orange, California, United States, 92868
      • University of California Irvine
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital
  • Florida
    • Hialeah, Florida, United States, 33012
      • Alternative Research Associates, LLC
    • Miami, Florida, United States, 33143
      • Alternative Research Associates, LLC
  • Illinois
    • Maywood, Illinois, United States, 60600
      • Loyola University Medical School
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard Medical School- Bringham and Women's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74101
      • Ascension Medical Group- St. John Clinic Infectious Disease
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fostamatinib (150 mg twice daily for 14 days) + Standard of Care	Drug: Fostamatinib; Fostamatinib (150 mg twice daily) for 14 days and Standard of Care; Other Names: Fostamatinib disodium
Placebo Comparator: Placebo (twice daily for 14 days) + Standard of Care	Drug: Placebo; Placebo (twice daily) for 14 days and Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	29 days
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).	29 days
All-cause mortality by Day 29.	All-cause mortality by Day 29.	29 days
All-cause mortality by Day 60	All-cause mortality by Day 60	60 days
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.	29 days
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	60 days
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	10 days

Collaborators and Investigators

• Sponsor: Rigel Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): September 5, 2022
• Study Completion (Actual): September 5, 2022

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: COVID19; Pneumonia, Viral; SARS-Associated Coronavirus Pneumonia
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections; Pneumonia; Pneumonia, Viral
• Other Study ID Numbers: C-935788-061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No