Acute Respiratory Distress SyndromePhase 2FOSTA-ARDSNCT06564207
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
A Phase 2 study testing Fostamatinib in people with Acute Respiratory Distress Syndrome and ARDS, run by Inova Health Care Services.
Trial summary
This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, ARDS
- What is being tested?
- Fostamatinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Functional respiratory imaging (FRI) compatible CT scan of the chest within the prior 7 days.
- Duration of invasive mechanical ventilation < 10 days.
- Females of childbearing potential must agree to be abstinent or seek a highly effective form of contraception from the time of enrollment through 30 days after the last day of study drug.
Who cannot join
- 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.
- Known concomitant life-threatening disease with a life expectancy < 6 months.
- Known hypersensitivity to fostamatinib.
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- Uncontrolled hypertension (Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).
- Neutrophil count < 1000/uL
- Death expected within 72 hours
- Received a live vaccine in the last 30 days
- Those who were cognitively impaired or mentally disabled prior to acute illness
- Patients with acute coronary syndrome, ejection fraction <30%, or active unstable arrhythmias
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study for the Long Term Evaluation of Fostamatinib for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome (ARDS)
This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).
Read the detailed description
This is a randomized, double-blind, placebo-controlled phase 2 study for long-term evaluation of fostamatinib for the treatment of adult patients with acute respiratory distress syndrome. Subjects will be randomly assigned 1:1 to either standard of care treatment plus fostamatinib or standard or care plus placebo. Th study drug will be taken twice daily for 14 days.
The primary objective will be to evaluate drug safety in hospitalized patients with severe ARDS. Other objectives include assessment of the efficacy and clinically relevant endpoints, such as mortality and effects on resolution of this disease entity. The ability of fostamatinib to impact the short term and long term outcomes for patients with ARDS will be directly evaluated.
- Conditions
- Acute Respiratory Distress Syndrome, ARDS
- Being tested
- Placebo, Fostamatinib
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo to be given twice daily for 14 days
FostamatinibDrug
Also called fostamatinib disodium
Fostamatinib 150mg to be given twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) + Placebo (BID for 14 Days) | Placebo comparator | Participants randomized to this arm will receive standard of care (SOC) treatment plus placebo given twice daily for 14 days Receives: Drug: Placebo |
| Standard of Care (SOC) + Fostamatinib 150mg (BID for 14 Days) | Experimental | Participants randomized to this arm will receive standard of care (SOC) treatment plus fostamatinib 150mg given twice daily for 14 days Receives: Drug: Fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start30 Nov 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to receive either fostamatinib plus standard of care or placebo plus standard of care.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Rigel Pharmaceuticals, Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Christopher S. King, MD, FACP, Principal investigator, Inova Schar Heart and Vascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564207
- Sponsor's protocol ID
- INOVA-2023-169
- Acronym
- FOSTA-ARDS
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study for the Long Term Evaluation of Fostamatinib for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT06564207
- Acronym / sponsor ID
- FOSTA-ARDS / INOVA-2023-169
- Conditions
- Acute Respiratory Distress Syndrome, ARDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Rigel Pharmaceuticals, Biomedical Advanced Research and Development Authority
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).
Detailed description
This is a randomized, double-blind, placebo-controlled phase 2 study for long-term evaluation of fostamatinib for the treatment of adult patients with acute respiratory distress syndrome. Subjects will be randomly assigned 1:1 to either standard of care treatment plus fostamatinib or standard or care plus placebo. Th study drug will be taken twice daily for 14 days.
The primary objective will be to evaluate drug safety in hospitalized patients with severe ARDS. Other objectives include assessment of the efficacy and clinically relevant endpoints, such as mortality and effects on resolution of this disease entity. The ability of fostamatinib to impact the short term and long term outcomes for patients with ARDS will be directly evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to receive either fostamatinib plus standard of care or placebo plus standard of care.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) + Placebo (BID for 14 Days) | Placebo comparator | Drug: PlaceboParticipants randomized to this arm will receive standard of care (SOC) treatment plus placebo given twice daily for 14 days |
| Standard of Care (SOC) + Fostamatinib 150mg (BID for 14 Days) | Experimental | Drug: FostamatinibParticipants randomized to this arm will receive standard of care (SOC) treatment plus fostamatinib 150mg given twice daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Functional respiratory imaging (FRI) compatible CT scan of the chest within the prior 7 days.
Key exclusion criteria (12 listed)
- 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.
- Known concomitant life-threatening disease with a life expectancy < 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo to be given twice daily for 14 days | Drug | Standard of Care (SOC) + Placebo (BID for 14 Days) |
| FostamatinibAlso: fostamatinib disodiumFostamatinib 150mg to be given twice daily for 14 days | Drug | Standard of Care (SOC) + Fostamatinib 150mg (BID for 14 Days) |
Primary outcome
Cumulative Incidence of Serious Adverse Events (SAEs) Through Day 30
Time frame: Up to 30 days post-intervention
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher S. King, MD, FACP principal investigator
Inova Schar Heart and Vascular
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fostamatinib in people with Acute Respiratory Distress Syndrome and ARDS, run by Inova Health Care Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edwinia Battle, RN, MSN ((703) 776-3067, edwinia.battle@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Serious Adverse Events (SAEs) Through Day 30 (time frame: Up to 30 days post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.