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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629703
Recruitment Status : Completed
First Posted : November 16, 2020
Last Update Posted : April 11, 2023
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 SARS (Severe Acute Respiratory Syndrome) SARS Pneumonia SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Pneumonia Pneumonia, Viral Drug: Fostamatinib Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Actual Study Start Date : March 25, 2021
Actual Primary Completion Date : September 5, 2022
Actual Study Completion Date : September 5, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
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 Name: Fostamatinib disodium
Placebo Comparator: Placebo (twice daily for 14 days) + Standard of Care
Placebo (twice daily for 14 days) + Standard of Care
 Drug: Placebo
Placebo (twice daily) for 14 days and Standard of Care


Outcome Measures
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Primary Outcome Measures :
  1. Number of days on oxygen from randomization on Day 1 to Day 29 [ Time Frame: 29 days ]
    Number of days on oxygen from randomization on Day 1 to Day 29


Secondary Outcome Measures :
  1. 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. [ Time Frame: 10 days ]
    Mean change from baseline over time in clinical status score using the 8-point ordinal

  2. Number of days in the ICU from randomization on Day 1 to Day 29 [ Time Frame: 29 days ]
    Number of days in the ICU from randomization on Day 1 to Day 29

  3. 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 ]
    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).

  4. All-cause mortality by Day 29. [ Time Frame: 29 days ]
    All-cause mortality by Day 29.

  5. All-cause mortality by Day 60 [ Time Frame: 60 days ]
    All-cause mortality by Day 60

  6. Proportion of subjects alive by Day 29 and oxygen free on Day 29. [ Time Frame: 29 days ]
    Proportion of subjects alive by Day 29 and oxygen free on Day 29.

  7. Proportion of subjects alive by Day 60 and oxygen free on Day 29 [ Time Frame: 60 days ]
    Proportion of subjects alive by Day 60 and oxygen free on Day 29


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629703


Locations
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Sponsors and Collaborators
Rigel Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04629703    
Other Study ID Numbers: C-935788-061
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rigel Pharmaceuticals:
COVID19
SARS-Associated Coronavirus Pneumonia
Pneumonia, Viral
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Respiratory Tract Infections
Infections
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases