Coronavirus Disease 2019Phase 2NCT04579393
Fostamatinib for Hospitalized Adults With COVID-19
A Phase 2 study testing fostamatinib in people with Coronavirus Disease 2019, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial summary
Background: COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- fostamatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2020to 30 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient must be hospitalized, or had their inpatient stay extended, for COVID-19.
- Age >=18 years
- Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
- Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- Females of childbearing potential must agree to be abstinent or use a medical acceptable form of contraception from the time of enrollment through 30 days after last day of study drug
- Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment
- Illness of any duration with SpO2 of less than 94% on room air requiring supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or mechanical ventilation or ECMO (5 to 7 on the 8-point scale)
Who cannot join
- ALT or AST > 5 times the upper limit of normal (ULN) or ALT or AST >= 3 x ULN and total bilirubin > 2 x ULN.
- Estimated glomerular filtration rate (eGFR) <30ml/min
- Pregnancy or breast feeding
- Anticipated discharge in the next 72 hours
- Allergy to study medication
- Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
Show all 13Show fewer
- Shock or hypotension at the time of enrollment
- Neutrophil count <1000/microliter
- Concern for bacterial or fungal sepsis
- Received immunomodulatory treatment within 30 days prior to enrollment e.g., Bruton's tyrosine kinase/phosphoinositide 3 kinase/Janus kinase inhibitor or cytokine-targeting biologic therapy (anti-TNF, IL-6)
- Received a live vaccine the last 4 weeks
- Those who were cognitively impaired or mentally disabled prior to COVID diagnosis
- Participation in another clinical trial for the treatment of COVID-19.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
INOVA Health Systems
Falls Church, Virginia, 22042
About this study
Official title: A Phase II Study Evaluating Fostamatinib for Hospitalized Adults With COVID-19
Background:
COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19.
Read more
Objective:
To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes.
Eligibility:
Adults age 18 and older who are hospitalized with COVID-19.
Design:
Participants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed.
Participants will be randomly assigned, to take either fostamatinib pills or a placebo twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit.
Participation will last for about two months
Read the detailed description
Coronavirus Disease 2019 (COVID-19) is the disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS) in a subset of patients with a known high mortality rate. Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock along with endothelial dysfunction and subsequently micro and macrovascular thrombosis.
Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a dysregulated immune response and more recently a hypercoagulable state leading to immunothrombosis. Currently, two therapies have shown efficacy in large multicenter trials for the treatment of COVID-19, one of which is an antiviral (remdesivir) and the other is an immunosuppressant corticosteroid meant to dampen the immune response (dexamethasone).
Spleen tyrosine kinase (SYK) is a cytoplasmic tyrosine kinase involved in the intracellular signaling pathways of many different immune cells. In this pilot study we propose to use fostamatinib (an SYK inhibitor) as a targeted therapy for the immunological complications of hospitalized patients with COVID-19. The biological mechanisms by which SYK inhibition may improve outcomes in patients with COVID-19 include the inhibition of pro-inflammatory cytokines by monocytes and macrophages, decreased production of neutrophil extracellular traps (NETs) by neutrophils, and inhibition of platelet aggregation; three pathways that are mediated through Fc receptors (FcR) recognition of antigen-antibody complexes or activation of c-type lectin receptors (CLEC).
This is a randomized, double-blind, placebo-controlled trial of fostamatinib for the treatment of hospitalized patients with COVID-19.
We will randomly assign fostamatinib or matched placebo (1:1) to 60 eligible COVID-19 patients who are a 5 to 7 on the 8-point scale (requiring supplemental oxygen via nasal canula or noninvasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation).
- Conditions
- Coronavirus Disease 2019
- Being tested
- Placebo, fostamatinib
- Keywords
- SARS-CoV-2, Cytokines, Spleen Tyrosine Kinase, ARDS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo tablets to match fostamatinib 100 mg and 150 mg will be provided.
fostamatinibDrug
The study intervention is fostamatinib, an inhibitor of spleen tyrosine kinase that will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. Subjects will receive standard of care and be randomized to receive fostamatinib or matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | fostamatinib in combination with standard of care (SOC) for the treatment of COVID-19 Receives: Drug: fostamatinib |
| Intervention - Placebo | Placebo comparator | Placebo in combination with standard of care (SOC) for the treatment of COVID-19 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least 1 Serious Adverse Event
Number of participants with at least 1 serious adverse event by day 29 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.
Measured: Day 29
Secondary outcomes (19)
Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less
Time to sustained recovery determined by ordinal scale score of 3 or less and defined as time to recovery [either discharge from the hospital or hospitalization for infection control reasons only], with the recovery status sustained through day 29.
The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Measured: day 29
Number of Participants Who Progress to Mechanical Ventilation
Number of participants who progress to mechanical ventilation by day 29
Measured: day 29
Number of Participants With Cumulative Clinical Endpoint of Death
Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60
Measured: day 14, day 28, day 60
Number of Grade 3 and 4 Adverse Events Through Day 60
Number of Grade 3 and 4 AE through day 60 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.
Measured: Day 60
Participant Score on Ordinal Scale
Participant score on ordinal scale at day 15 and day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Measured: Day 15, Day 29
Change in C-Reactive Protein Levels From Baseline
Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter).
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Fibrinogen Levels From Baseline.
Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL).
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in D-Dimer Levels From Baseline
Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter).
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Ferritin Levels From Baseline
Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter).
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Interleukin 6 (IL6) Levels From Baseline
Change in Interleukin 6 (IL6) blood levels from baseline. The upper limit of normal for IL6 is 1.8 picograms per milliliter (pg/mL).
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Median Days Participants Were Admitted to Intensive Care Unit
Median days participants were admitted to Intensive Care Unit (ICU) by day 29
Measured: Day 29
Relative Change in SpO2/FiO2 Ratio
Relative change in PaO2/FiO2 or SpO2/FiO2 ratio.
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in SOFA Score From Baseline
Change in SOFA score from baseline (day 1). The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Median Days on Participants Received Supplemental Oxygen
Median days on participants received supplemental oxygen through day 29
Measured: day 29
The Number of Participants That Experienced Acute Renal Failure
The number of participants that experienced acute renal failure by day 29.
Acute renal failure defined as increase in serum creatinine by ≥0.3mg/dL within 48 hours or increase in serum creatinine by ≥1.5 times baseline which is known or presumed to have occurred within the prior seven days.
Measured: day 29
Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Number of participants that experienced a deep vein thrombosis (DVT) or pulmonary embolism (PE) by day 29
Measured: day 29
Change in Absolute Lymphocyte Count Levels From Baseline
Change in Absolute lymphocyte count blood levels from baseline.
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Absolute Neutrophil Count Levels From Baseline
Change in Absolute neutrophil count blood levels from baseline.
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Platelet Count Levels From Baseline
Change in Platelet count blood levels from baseline.
Measured: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start8 Oct 2020
- Primary completion30 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Strich, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579393
- Sponsor's protocol ID
- 10000110
- Other IDs
- 000110-H
- Status last verified
- May 2021
- First submitted
- 6 Oct 2020
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Strich JR, Tian X, Samour M, King CS, Shlobin O, Reger R, Cohen J, Ahmad K, Brown AW, Khangoora V, Aryal S, Migdady Y, Kyte JJ, Joo J, Hays R, Collins AC, Battle E, Valdez J, Rivero J, Kim IH, Erb-Alvarez J, Shalhoub R, Chakraborty M, Wong S, Colton B, Ramos-Benitez MJ, Warner S, Chertow DS, Olivier KN, Aue G, Davey RT, Suffredini AF, Childs RW, Nathan SD. Fostamatinib for the Treatment of Hospitalized Adults With Coronavirus Disease 2019: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):e491-e498. doi: 10.1093/cid/ciab732.
PubMed 34467402Strich JR, Ramos-Benitez MJ, Randazzo D, Stein SR, Babyak A, Davey RT, Suffredini AF, Childs RW, Chertow DS. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. J Infect Dis. 2021 Mar 29;223(6):981-984. doi: 10.1093/infdis/jiaa789.
PubMed 33367731
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating Fostamatinib for Hospitalized Adults With COVID-19
- ClinicalTrials.gov ID
- NCT04579393
- Acronym / sponsor ID
- 10000110
- Conditions
- Coronavirus Disease 2019
- Keywords
- SARS-CoV-2, Cytokines, Spleen Tyrosine Kinase, ARDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19.
Objective:
To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes.
Eligibility:
Adults age 18 and older who are hospitalized with COVID-19.
Design:
Participants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed.
Participants will be randomly assigned, to take either fostamatinib pills or a placebo twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit.
Participation will last for about two months
Detailed description
Coronavirus Disease 2019 (COVID-19) is the disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS) in a subset of patients with a known high mortality rate. Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock along with endothelial dysfunction and subsequently micro and macrovascular thrombosis.
Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a dysregulated immune response and more recently a hypercoagulable state leading to immunothrombosis. Currently, two therapies have shown efficacy in large multicenter trials for the treatment of COVID-19, one of which is an antiviral (remdesivir) and the other is an immunosuppressant corticosteroid meant to dampen the immune response (dexamethasone).
Spleen tyrosine kinase (SYK) is a cytoplasmic tyrosine kinase involved in the intracellular signaling pathways of many different immune cells. In this pilot study we propose to use fostamatinib (an SYK inhibitor) as a targeted therapy for the immunological complications of hospitalized patients with COVID-19. The biological mechanisms by which SYK inhibition may improve outcomes in patients with COVID-19 include the inhibition of pro-inflammatory cytokines by monocytes and macrophages, decreased production of neutrophil extracellular traps (NETs) by neutrophils, and inhibition of platelet aggregation; three pathways that are mediated through Fc receptors (FcR) recognition of antigen-antibody complexes or activation of c-type lectin receptors (CLEC).
This is a randomized, double-blind, placebo-controlled trial of fostamatinib for the treatment of hospitalized patients with COVID-19.
We will randomly assign fostamatinib or matched placebo (1:1) to 60 eligible COVID-19 patients who are a 5 to 7 on the 8-point scale (requiring supplemental oxygen via nasal canula or noninvasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: fostamatinibfostamatinib in combination with standard of care (SOC) for the treatment of COVID-19 |
| Intervention - Placebo | Placebo comparator | Drug: PlaceboPlacebo in combination with standard of care (SOC) for the treatment of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (13 listed)
- ALT or AST > 5 times the upper limit of normal (ULN) or ALT or AST >= 3 x ULN and total bilirubin > 2 x ULN.
- Estimated glomerular filtration rate (eGFR) <30ml/min
- Pregnancy or breast feeding
- Anticipated discharge in the next 72 hours
- Allergy to study medication
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 tablets to match fostamatinib 100 mg and 150 mg will be provided. | Drug | Intervention - Placebo |
| fostamatinibThe study intervention is fostamatinib, an inhibitor of spleen tyrosine kinase that will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. Subjects will receive standard of care and be randomized to receive fostamatinib or matching placebo. | Drug | Intervention |
Primary outcome
Number of Participants With at Least 1 Serious Adverse Event
Time frame: Day 29
Number of participants with at least 1 serious adverse event by day 29 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.
19 secondary outcomes
Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less
Time frame: day 29
Number of Participants Who Progress to Mechanical Ventilation
Time frame: day 29
Number of Participants With Cumulative Clinical Endpoint of Death
Time frame: day 14, day 28, day 60
Number of Grade 3 and 4 Adverse Events Through Day 60
Time frame: Day 60
Participant Score on Ordinal Scale
Time frame: Day 15, Day 29
Change in C-Reactive Protein Levels From Baseline
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Fibrinogen Levels From Baseline.
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in D-Dimer Levels From Baseline
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Ferritin Levels From Baseline
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Interleukin 6 (IL6) Levels From Baseline
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Median Days Participants Were Admitted to Intensive Care Unit
Time frame: Day 29
Relative Change in SpO2/FiO2 Ratio
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in SOFA Score From Baseline
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Median Days on Participants Received Supplemental Oxygen
Time frame: day 29
The Number of Participants That Experienced Acute Renal Failure
Time frame: day 29
Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Time frame: day 29
Change in Absolute Lymphocyte Count Levels From Baseline
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Absolute Neutrophil Count Levels From Baseline
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Change in Platelet Count Levels From Baseline
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34467402Strich JR, Tian X, Samour M, King CS, Shlobin O, Reger R, Cohen J, Ahmad K, Brown AW, Khangoora V, Aryal S, Migdady Y, Kyte JJ, Joo J, Hays R, Collins AC, Battle E, Valdez J, Rivero J, Kim IH, Erb-Alvarez J, Shalhoub R, Chakraborty M, Wong S, Colton B, Ramos-Benitez MJ, Warner S, Chertow DS, Olivier KN, Aue G, Davey RT, Suffredini AF, Childs RW, Nathan SD. Fostamatinib for the Treatment of Hospitalized Adults With Coronavirus Disease 2019: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):e491-e498. doi: 10.1093/cid/ciab732.
- Derived from this study: PubMed 33367731Strich JR, Ramos-Benitez MJ, Randazzo D, Stein SR, Babyak A, Davey RT, Suffredini AF, Childs RW, Chertow DS. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. J Infect Dis. 2021 Mar 29;223(6):981-984. doi: 10.1093/infdis/jiaa789.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Jeffrey R Strich, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fostamatinib in people with Coronavirus Disease 2019, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
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 13 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: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With at Least 1 Serious Adverse Event (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579393, which also lists 2 linked publications.
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 2 Mar 2022.