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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

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.

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Actual Study Start Date : February 22, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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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.

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


Contacts
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Contact: Johanna Riesen (650) 624-1100 clinicaltrials@rigel.com

Locations
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Sponsors and Collaborators
Rigel Pharmaceuticals
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: June 30, 2021
Last Verified: November 2020

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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