Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults

ConditionsAcute Respiratory Distress Syndrome ARDS

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorInova Health Care Services

About this trial

This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old.

Subject (or legal representative) provides informed consent to study participation.

Subject (or legal representative) understands and agrees to comply with planned study procedures.

Hospitalized with acute respiratory failure from ARDS with ratio of partial pressure of arterial oxygen to fraction of inspired oxygen PaO2/FiO2 of 200 mm of Hg or less with positive end expiratory pressure (PEEP) equal to or higher than 5 cm of H2O and requiring invasive mechanical ventilation or extracorporeal support.

Disqualifiers

Severe hepatic impairment (Child-Pugh Class C).

Abnormal liver function tests (AST or ALT > 3x ULN or AST or ALT > 3x ULN)

Pregnant or nursing.

Participation in any other clinical trial, or receipt of an investigational medicinal product within 30 days prior.

Trial design

Design model

Parallel

Treatments tested in this trial

Placebo
Drug
Placebo to be given twice daily for 14 days
Fostamatinib
Drug
Fostamatinib 150mg to be given twice daily for 14 days

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Standard of Care (SOC) + Placebo (BID for 14 Days)Placebo comparator 1 intervention

Group B: Standard of Care (SOC) + Fostamatinib 150mg (BID for 14 Days)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Cumulative Incidence of Serious Adverse Events (SAEs) Through Day 30

The cumulative incidence of serious adverse events (SAEs) occurring through day 30 following the intervention. An SAE is defined by the International Conference on Harmonization (ICH) guidelines as any adverse event fulfilling at least one of the following criteria: Results in death; Is life threatening; Requires in-subject hospitalization or prolongation of an existing hospitalization; Results in persistent or significant disability/incapacity; Is considered an important medical event (or medically significant)

Time frame

Up to 30 days post-intervention

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inova Health Care Services

Lead sponsor

Rigel Pharmaceuticals

Collaborator

Biomedical Advanced Research and Development Authority