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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostamatinib (150 mg twice daily for 14 days) + Standard of Care | Active Comparator | Fostamatinib (150 mg twice daily for 14 days) + Standard of Care |
|
| Placebo (twice daily for 14 days) + Standard of Care | Placebo Comparator | Placebo (twice daily for 14 days) + Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib | Drug | Fostamatinib (150 mg twice daily) for 14 days and Standard of Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days on oxygen from randomization on Day 1 to Day 29 | Number of days on oxygen from randomization on Day 1 to Day 29 | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Mean change from baseline over time in clinical status score using the 8-point ordinal | 10 days |
| Number of days in the ICU from randomization on Day 1 to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| George Washington University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | 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. |
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| Placebo | Drug | Placebo (twice daily) for 14 days and Standard of Care |
|
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 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. | All-cause mortality by Day 29. | 29 days |
| All-cause mortality by Day 60 | All-cause mortality by Day 60 | 60 days |
| Proportion of subjects alive by Day 29 and oxygen free on Day 29. | 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 | Proportion of subjects alive by Day 60 and oxygen free on Day 29 | 60 days |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| Alternative Research Associates, LLC | Hialeah | Florida | 33012 | United States |
| Alternative Research Associates, LLC | Miami | Florida | 33143 | United States |
| Loyola University Medical School | Maywood | Illinois | 60600 | United States |
| Harvard Medical School- Bringham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford | Detroit | Michigan | 48202 | United States |
| Ascension Medical Group- St. John Clinic Infectious Disease | Tulsa | Oklahoma | 74101 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| Corporacion Medica de General San Martin | San Martín | Buenos Aires | CP 1650 | Argentina |
| Clinica Chutro | Córdoba | CP | EPU5000 | Argentina |
| Hospital Lencinas | Godoy Cruz | Mendoza Province | PC: 5547 | Argentina |
| Hospital de Alta Complejidad Cuenta Alta | Buenos Aires | B1814 | Argentina |
| Hospital Del Bicentenario - Dr. Luis Federico Leloir | Buenos Aires | B1842 | Argentina |
| Clinica Zabala | Buenos Aires | C1426 | Argentina |
| Clinica Adventista Belgrano | Buenos Aires | Argentina |
| Clinica Monte Grande | Buenos Aires | Argentina |
| Hospital de Infecciosas Dr.Francisco Javier Muñiz | Buenos Aires | Argentina |
| Sanatorio Guemes | Buenos Aires | Argentina |
| Sanatorio Sagrado Corazon | Buenos Aires | Argentina |
| Hospital San Roque | Córdoba | Argentina |
| Sanatorio Mayo Privado | Córdoba | Argentina |
| Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG) | Goiânia | Goiás | 74605 | Brazil |
| Hospital Luxenburgo-Associação Mário Penna | Belo Horizonte | Minas Gerais | 30380 | Brazil |
| Hosp. Angelina Caron | Campina Grande do Sul | Paraná | 83430-000 | Brazil |
| Hospital Universitario de Maringa | Maringá | Paraná | 87083 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA | Porto Alegre | Rio Grande do Sul | 90020 | Brazil |
| Hospital des clinicas de porto alegre - Centro de pequisas clinicas | Porto Alegre | Rio Grande do Sul | 90035 - 903 | Brazil |
| Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA | Blumenau | Santa Catarina | 89030 | Brazil |
| Hospital Alemão Oswaldo Cruz (HAOC) | Bela Vista | São Paulo | 01323 | Brazil |
| Hospital Universitário São Francisco na Providência de Deus | Bragança Paulista | São Paulo | 12916-542 | Brazil |
| Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) | Campinas | São Paulo | 13060 | Brazil |
| Hospital Bandeirantes (LeForte) | Liberdade | São Paulo | 01506 | Brazil |
| Fundação Faculdade Reg. de Med de SJRP | São José do Rio Preto | São Paulo | 15090 | Brazil |
| Clinica de Alergia Martti Antila S/S Ltda | Sorocaba | São Paulo | 18040 | Brazil |
| Unidad Medica para la Salud Integral (UMSI) | Monterrey | Nuevo León | Mexico |
| Star Medica Vivo Bicentenario | Nezahualcóyotl | State of Mexico | 57205 | Mexico |
| Köhler & Milstein Research | Mérida | Yucatán | 97070 | Mexico |
| Hospital Cardiologica Aguascalientes | Aguascalientes | Mexico |
| Icaro Investigaciones en Medicina | Chihuahua City | CP:3100 | Mexico |
| Nuevo Hospital Civil de Guadalajara | Guadalajara | Mexico |
| Centro Medico Issemym Toluca | Metepec | Mexico |
| The American British Cowdray Medical Center I.A.P. | Mexico City | Mexico |
| Hospital Ángeles Roma | México | Mexico |
| CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas | Nuevo León | Mexico |
| Hospital Civil de Culiacan | Sinaloa | 80230 | Mexico |
| Hospital Civil de Culiacan | Sinaloa | Mexico |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D011014 | Pneumonia |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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