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

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ClinicalTrials.gov Identifier: NCT04629703
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 13, 2020
First Posted Date  ICMJE November 16, 2020
Last Update Posted Date June 30, 2021
Actual Study Start Date  ICMJE February 22, 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2020)
Progression to severe/critical disease within 29 days of first dose of study treatment [ Time Frame: 29 days ]
Progression to severe/critical disease within 29 days of first dose of study treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29 [ Time Frame: 29 days ]
    Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29
  • Total number of calendar days hospitalized from day of randomization up to Day 29 [ Time Frame: 29 days ]
    Total number of calendar days hospitalized from day of randomization up to Day 29
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2020)
  • Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29 [ Time Frame: 29 days ]
    Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29
  • Total number of calendar days hospitalized through Day 29 [ Time Frame: 29 days ]
    Total number of calendar days hospitalized through Day 29
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-Blind, Randomized, Placebo-Controlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Official Title  ICMJE Double-Blind, Randomized, Placebo-Controlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Brief Summary The study is a double-blind, randomized, placebo-controlled, adaptive design, 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 and safety of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID-19 without respiratory failure and with certain high risk prognostic factors.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • SARS (Severe Acute Respiratory Syndrome)
  • SARS Pneumonia
  • SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  • Pneumonia
  • Pneumonia, Viral
Intervention  ICMJE
  • Drug: Fostamatinib
    Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
    Other Name: Fostamatinib disodium
  • Drug: Placebo
    Placebo (twice daily) for 14 days and Standard of Care
Study Arms  ICMJE
  • Active Comparator: Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
    Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
    Intervention: Drug: Fostamatinib
  • Placebo Comparator: Placebo (twice daily for 14 days) + Standard of Care
    Placebo (twice daily for 14 days) + Standard of Care
    Intervention: Drug: Placebo
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:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2020)
308
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johanna Riesen (650) 624-1100 clinicaltrials@rigel.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Mexico,   Peru,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04629703
Other Study ID Numbers  ICMJE C-935788-061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rigel Pharmaceuticals
Study Sponsor  ICMJE Rigel Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rigel Pharmaceuticals
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP