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

August 15, 2023 updated by: Rigel Pharmaceuticals
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Clinica 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 Corazón
      • 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 Misericordia 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 Universitário São Francisco na Providência 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 Médica 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
29 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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 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).
29 days
All-cause mortality by Day 29.
Time Frame: 29 days
All-cause mortality by Day 29.
29 days
All-cause mortality by Day 60
Time Frame: 60 days
All-cause mortality by Day 60
60 days
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.
29 days
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
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.
Time Frame: 10 days
Mean change from baseline over time in clinical status score using the 8-point ordinal
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigel Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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