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

CompletadoFase 3ClinicalTrials.gov

ID: NCT04629703Tipo: INTERVENTIONALInicio: 25 de mar de 2021Fin estimado: 5 de sept de 2022

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Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

≥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.

Criterios de exclusión

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.

Intervenciones

drug

Fostamatinib

Fostamatinib (150 mg twice daily) for 14 days and Standard of Care

drug

Placebo

Placebo (twice daily) for 14 days and Standard of Care

Ubicaciones

Corporacion Medica de General San Martin

San Martín, Buenos Aires, Argentina

Clinica Chutro

Córdoba, CP, Argentina

Hospital Lencinas

Godoy Cruz, Mendoza Province, Argentina

Hospital de Alta Complejidad Cuenta Alta

Buenos Aires, Argentina

Hospital Del Bicentenario - Dr. Luis Federico Leloir

Buenos Aires, Argentina

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 Guemes

Buenos Aires, Argentina

Sanatorio Sagrado Corazon

Buenos Aires, Argentina

Hospital San Roque

Córdoba, Argentina

Sanatorio Mayo Privado

Córdoba, Argentina

Patrocinadores

PrincipalRigel Pharmaceuticals

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