Clinical trial NCT04629703: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
SARS (Severe Acute Respiratory Syndrome)
SARS Pneumonia
SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Pneumonia
Pneumonia, Viral
Keywords: COVID19
SARS-Associated Coronavirus Pneumonia
Pneumonia, Viral
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and requiring oxygen supplementation, as measured by days on oxygen.

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.

Primary outcomes:
measure: Number of days on oxygen from randomization on Day 1 to Day 29
timeFrame: 29 days
Secondary outcomes:
measure: 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.
timeFrame: 10 days
measure: Number of days in the ICU from randomization on Day 1 to Day 29
timeFrame: 29 days
measure: 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).
timeFrame: 29 days
measure: All-cause mortality by Day 29.
timeFrame: 29 days
measure: All-cause mortality by Day 60
timeFrame: 60 days
measure: Proportion of subjects alive by Day 29 and oxygen free on Day 29.
timeFrame: 29 days
measure: Proportion of subjects alive by Day 60 and oxygen free on Day 29
timeFrame: 60 days
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Hialeah
country: United States
facility: Alternative Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Alternative Research Associates, LLC
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical School
state: Illinois
city: Boston
country: United States
facility: Harvard Medical School- Bringham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Tulsa
country: United States
facility: Ascension Medical Group- St. John Clinic Infectious Disease
state: Oklahoma
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Cordoba
country: Argentina
facility: Clinica Chutro
state: CP
city: Godoy Cruz
country: Argentina
facility: Hospital Lencinas
state: Mendoza
city: San Martin
country: Argentina
facility: Corporacion Medica de General San Martin
state: Provincia De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital de Alta Complejidad Cuenta Alta
city: Buenos Aires
country: Argentina
facility: Hospital Del Bicentenario - Dr. Luis Federico Leloir
city: Buenos Aires
country: Argentina
facility: Clinica Zabala
city: Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Buenos Aires
country: Argentina
facility: Clinica Monte Grande
city: Buenos Aires
country: Argentina
facility: Hospital de Infecciosas Dr.Francisco Javier Muñiz
city: Buenos Aires
country: Argentina
facility: Sanatorio Guemes
city: Buenos Aires
country: Argentina
facility: Sanatorio Sagrado Corazon
city: Córdoba
country: Argentina
facility: Hospital San Roque
city: Córdoba
country: Argentina
facility: Sanatorio Mayo Privado
city: Goiânia
country: Brazil
facility: Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG)
state: Goiás
city: Belo Horizonte
country: Brazil
facility: Hospital Luxenburgo-Associação Mário Penna
state: Minas Gerais
city: Maringá
country: Brazil
facility: Hospital Universitario de Maringa
state: Parana
city: Campina Grande do Sul
country: Brazil
facility: Hosp. Angelina Caron
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
state: Rio Grande Do Sul
city: Porto Alegre,
country: Brazil
facility: Hospital des clinicas de porto alegre - Centro de pequisas clinicas
state: RS
city: Blumenau
country: Brazil
facility: Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA
state: Santa Catarina
city: Bela Vista
country: Brazil
facility: Hospital Alemão Oswaldo Cruz (HAOC)
state: Sao Paolo
city: Campinas
country: Brazil
facility: Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)
state: Sao Paolo
city: Liberdade
country: Brazil
facility: Hospital Bandeirantes (LeForte)
state: Sao Paolo
city: Braganca Paulista
country: Brazil
facility: Hospital Universitário São Francisco na Providência de Deus
state: Sao Paulo
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila S/S Ltda
state: Sao Paulo
city: São José Do Rio Preto
country: Brazil
facility: Fundação Faculdade Reg. de Med de SJRP
state: Sao Paulo
city: Nezahualcóyotl
country: Mexico
facility: Star Medica Vivo Bicentenario
state: Mex
city: Monterrey
country: Mexico
facility: Unidad Medica para la Salud Integral (UMSI)
state: Nuevo Leon
city: Mérida
country: Mexico
facility: Köhler & Milstein Research
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Chihuahua
country: Mexico
facility: Icaro Investigaciones en Medicina
city: Guadalajara
country: Mexico
facility: Nuevo Hospital Civil de Guadalajara
city: Metepec
country: Mexico
facility: Centro Medico Issemym Toluca
city: Mexico City
country: Mexico
facility: The American British Cowdray Medical Center I.A.P.
city: Mexico
country: Mexico
facility: Hospital Ángeles Roma
city: Nuevo León
country: Mexico
facility: CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
city: Sinaloa
country: Mexico
facility: Hospital Civil de Culiacan
city: Sinaloa
country: Mexico
facility: Hospital Civil de Culiacan
Study officials:
References:
citation: 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(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.