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

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

Tracking Information

• First Submitted Date: November 13, 2020
• First Posted Date: November 16, 2020
• Last Update Posted Date: November 30, 2021
• Actual Study Start Date: February 22, 2021
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (submitted: November 19, 2021)

Proportion of subjects transferred into the intensive care unit (ICU) or who died by Day 29 [ Time Frame: 29 days ]

Proportion of subjects transferred into the intensive care unit (ICU) or who died by Day 29

Original Secondary Outcome Measures (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: 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
• 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 without respiratory failure and with certain high risk prognostic factors, as measured by the change in clinical status score.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Covid19
• SARS (Severe Acute Respiratory Syndrome)
• SARS Pneumonia
• SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
• Pneumonia
• Pneumonia, Viral

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 13, 2020): 308
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2022
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Gabrielle Khedr; (650) 624-1100; clinicaltrials@rigel.com

Contact: Sandra Jimenez; (650) 624-1100; clinicaltrials@rigel.com

• Listed Location Countries: Argentina, Brazil, Mexico, Peru, United States

Administrative Information

• NCT Number: NCT04629703
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Rigel Pharmaceuticals
• Study Sponsor: Rigel Pharmaceuticals
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rigel Pharmaceuticals
• Verification Date: November 2021