COVID-19 viral infection MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Fostamatinib
Product Code: [Non applicabile]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib
Current Sponsor code: Non applicabile
Other descriptive name: FOSTA
Sponsors
NEAT ID Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalized for COVID-19 2. =18 years of age 3. SARS-CoV-2 infection, documented by: a. a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR b. documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained in Appendix G.) 4. Hypoxemia, defined as SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 1. COVID-19 symptom onset >14 days prior to randomization 2. Hospitalized for >72 hours prior to randomization 3. Pregnancy 4. Breastfeeding 5. Prisoners 6. End-stage renal disease (ESRD) on dialysis 7. Patient and/or clinical team is not pursuing full medical management (if a patient has a Do Not Resuscitate order that precludes chest compressions in the event of a cardiac arrest but is otherwise pursuing full medical management, he/she is eligible for this trial). 8. The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient See agent-specific appendices in the full protocol for agent-specific exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. Potential agents to investigate on this platform include, but are not limited to, Fostamatinib. These agents all impact the host tissue response in COVID-19 via a number of unique mechanisms including potential beneficial effects on the RAAS system and formation of neutrophil extracellular traps. We will evaluate the efficacy of these agents’ ability to impact the host tissue response and improve outcomes in patients hospitalized with COVID-19.;Secondary Objective: A further objective is to determine which of the different renin angiotensin aldosterone system (RAAS) agents’ targets and associated mechanisms of action, when added to current best practice and compared to current best practice plus placebo, result in an effective therapeutic approach to the RAAS system in patients infected with SARS-CoV-2.;Primary end point(s): The number of oxygen-free days at day 28.;Timepoint(s) of evaluation of this end point: day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Alive and oxygen free at days 14 and 28 • Alive and respiratory failure-free at days 14 and 28 • Alive and free of new invasive mechanical ventilation at 14 and 28 days • In-hospital, 28-day, 60-day and 90-day mortality • WHO 8-point ordinal scale at 14, 28 and 60 days • Support-free days to Day 28, including: Hospital-free days Respiratory failure-free days Ventilator-free days;Timepoint(s) of evaluation of this end point: day 60 and day 90 | — |
Countries
Brazil, France, Germany, Italy, South Africa, Spain
Contacts
Public ContactProject Manager
Research Organisation (KC)
Outcome results
None listed