A Phase 2 interventional study of Placebo and fostamatinib in Coronavirus Disease 2019, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 2, Interventional, and Treatment
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
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).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 59 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient must be hospitalized, or had their inpatient stay extended, for COVID-19.
EXCLUSION CRITERIA:
fostamatinib in combination with standard of care (SOC) for the treatment of COVID-19
Drug: fostamatinib
Placebo in combination with standard of care (SOC) for the treatment of COVID-19
Drug: Placebo
Placebo tablets to match fostamatinib 100 mg and 150 mg will be provided.
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.
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.
Time frame: Day 29
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.
Time frame: day 29
Number of Participants Who Progress to Mechanical Ventilation
Number of participants who progress to mechanical ventilation by day 29
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: Day 29
Relative Change in SpO2/FiO2 Ratio
Relative change in PaO2/FiO2 or SpO2/FiO2 ratio.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: day 29
Change in Absolute Lymphocyte Count Levels From Baseline
Change in Absolute lymphocyte count blood 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
Change in Absolute neutrophil count blood levels from baseline.
Time frame: 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.
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Participants were enrolled from October 8, 2020, through March 2, 2021 across 2 centers: Inova Fairfax Hospital (Falls Church, VA) and the National Institutes of Health (NIH) Clinical Center (Bethesda, MD).
| Milestone | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Started | 30 | 29 |
| Completed | 27 | 24 |
| Not completed | 3 | 5 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Death | 1 | 3 |
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.
| Participants | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Number of Participants With at Least 1 Serious Adverse Event | 3 | 6 |
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.
| Participants | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | 27 | 22 |
Number of participants who progress to mechanical ventilation by day 29
| Participants | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Number of Participants Who Progress to Mechanical Ventilation | 1 | 2 |
Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60
| Participants | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| day 14 | 0 | 1 |
| day 28 | 0 | 3 |
| day 60 | 1 | 3 |
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.
| Adverse Events | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Grade 3 | 17 | 23 |
| Grade 4 | 3 | 7 |
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.
| score on a scale | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 15 | 1 (1 to 2) | 2 (1 to 5) |
| Day 29 | 1 (1 to 2) | 1 (1 to 2) |
Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter).
| mg/L (milligrams per liter) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | -37 (-94 to -6) | -46 (-105 to -1) |
| Day 5 | -34 (-84 to 5) | -51 (-128 to -23) |
| Day 8 | -56 (-108 to -17) | -66 (-118 to -39) |
| Day 11 | -52 (-114 to -29) | -68 (-139 to -46) |
| Day 15 | -43 (-109 to -33) | -71 (-126 to -47) |
| Day 29 | -65 (-117 to -33) | -106 (-155 to -57) |
Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL).
| mg/dL (milligrams per decilitre) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | -60 (-177 to -11) | -65 (-155 to 41) |
| Day 5 | -86 (-187 to 2) | -78 (-245 to 36) |
| Day 8 | -130 (-260 to -34) | -96 (-236 to -40) |
| Day 11 | -141 (-277 to -77) | -138 (-250 to -14) |
| Day 15 | -132 (-182 to -24) | -76 (-214 to 10) |
| Day 29 | -113 (-235 to -63) | -231 (-351 to -64) |
Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter).
| mcg/mL (microgram per milliliter) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | -0.01 (-0.19 to 0.25) | -0.08 (-0.4 to 0.31) |
| Day 5 | -0.06 (-0.24 to 0.11) | -0.1 (-0.74 to 0.15) |
| Day 8 | -0.15 (-0.74 to 0.07) | -0.24 (-1.25 to 0.1) |
| Day 11 | -0.11 (-0.56 to 0.12) | -0.43 (-0.99 to 0.06) |
| Day 15 | -0.06 (-0.2 to 0.12) | -0.32 (-1.02 to 0) |
| Day 29 | -0.15 (-0.31 to 0) | -0.16 (-0.82 to 0.46) |
Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter).
| mcg/L (micrograms per liter) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | -94 (-306 to 20) | -190 (-622 to -102) |
| Day 5 | -213 (-532 to -25) | -199 (-684 to 16) |
| Day 8 | -73 (-428 to 438) | -253 (-586 to -17) |
| Day 11 | -169 (-853 to 93) | -491 (-756 to -239) |
| Day 15 | -346 (-904 to 4) | -561 (-882 to -350) |
| D29 | -578 (-1038 to -206) | -738 (-1562 to -530) |
Change in Interleukin 6 (IL6) blood levels from baseline. The upper limit of normal for IL6 is 1.8 picograms per milliliter (pg/mL).
| pg/mL (picograms per milliliter) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | -0.7 (-11.5 to 1.4) | 1.4 (-2.6 to 6.9) |
| Day 5 | -1 (-16.1 to 4.4) | 0.3 (-1.8 to 4.5) |
| Day 8 | 0 (-5.5 to 3.8) | -2.5 (-6.6 to 0) |
| Day 11 | -0.1 (-9.9 to 1.4) | -0.3 (-8.2 to 0.3) |
| Day 15 | -1.5 (-5.5 to 1) | -0.7 (-4.3 to 0.5) |
| Day 29 | -1.4 (-6.5 to -0.4) | -1.4 (-4 to -0.8) |
Median days participants were admitted to Intensive Care Unit (ICU) by day 29
| Days | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Median Days Participants Were Admitted to Intensive Care Unit | 3 (2 to 5) | 7 (2 to 10) |
Relative change in PaO2/FiO2 or SpO2/FiO2 ratio.
| SpO2/FiO2 ratio | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | 0.87 (0.7 to 0.97) | 0.93 (0.65 to 1.04) |
| Day 5 | 1.09 (0.75 to 1.33) | 0.88 (0.76 to 1.08) |
| Day 8 | 0.75 (0.59 to 1.83) | 1.09 (0.59 to 1.39) |
| Day 11 | 1.49 (0.81 to 2.14) | 0.99 (0.53 to 1.59) |
| Day 15 | 1.23 (0.87 to 1.5) | 1.07 (0.67 to 1.79) |
| Day 29 | 0.74 (0.74 to 0.74) | 0.49 (0.42 to 0.97) |
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.
| score on a SOFA scale | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | 0 (0 to 0) | 0 (-1 to 0) |
| Day 5 | 0 (-1 to 0) | 0 (0 to 0) |
| Day 8 | 0 (-1 to 1) | 0 (-1 to 0) |
| Day 11 | 0 (-1 to 0) | 0 (0 to 2) |
| Day 15 | -1 (-2 to 0) | 0 (-1 to 2) |
| Day 29 | 0 (0 to 0) | 1 (0 to 2) |
Median days on participants received supplemental oxygen through day 29
| days | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Median Days on Participants Received Supplemental Oxygen | 8 (5 to 10) | 20 (14 to 27) |
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.
| Participants | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| The Number of Participants That Experienced Acute Renal Failure | 3 | 5 |
Number of participants that experienced a deep vein thrombosis (DVT) or pulmonary embolism (PE) by day 29
| Participants | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) | 2 | 0 |
Change in Absolute lymphocyte count blood levels from baseline.
| thousand cells per microliter | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | 0.43 (0.02 to 0.64) | 0.13 (-0.18 to 0.42) |
| Day 5 | 0.48 (0.08 to 1.03) | 0.38 (-0.14 to 0.73) |
| Day 8 | 0.41 (0.06 to 1.22) | 0.34 (-0.02 to 1.09) |
| Day 11 | 1.03 (0.15 to 1.37) | 1.02 (0.57 to 1.44) |
| Day 15 | 1.03 (0.52 to 1.18) | 0.68 (0.25 to 1.07) |
| Day 29 | 0.56 (0.42 to 0.89) | 0.81 (0.42 to 1.38) |
Change in Absolute neutrophil count blood levels from baseline.
| thousand cells per microliter | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | 0.04 (-1.22 to 1.06) | -0.09 (-2.06 to 1.88) |
| Day 5 | 1.53 (-2.31 to 2.5) | 0.94 (-0.97 to 2.1) |
| Day 8 | 0.63 (-3.4 to 3.78) | 2.74 (-0.4 to 6.26) |
| Day 11 | -0.95 (-2.34 to 1.1) | 0.85 (-1.42 to 2.6) |
| Day 15 | -1.77 (-3.41 to -0.6) | -1.6 (-5.22 to 1.61) |
| Day 29 | -2.54 (-4.62 to -1.12) | -2.89 (-7.9 to -0.22) |
Change in Platelet count blood levels from baseline.
| thousand cells per microliter | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Day 3 | 59 (19 to 117) | 58 (24 to 103) |
| Day 5 | 103 (55 to 150) | 63 (1 to 142) |
| Day 8 | 145 (91 to 217) | 62 (-34 to 171) |
| Day 11 | 80 (20 to 156) | 25 (-132 to 128) |
| Day 15 | 11 (-30 to 92) | -26 (-198 to 26) |
| Day 29 | -29 (-87 to 42) | -7 (-102 to 60) |
Collected over 60 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | 1/30 (3.3%) | 5/30 (16.7%) | 8/30 (26.7%) |
| Placebo With Standard of Care for Treatment of COVID-19 | 3/29 (10.3%) | 10/29 (34.5%) | 15/29 (51.7%) |
| Event | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/30 | 3/29 |
| Multi-organ failureGeneral disorders | 0/30 | 1/29 |
| Allergic reactionImmune system disorders | 0/30 | 1/29 |
| Lung infectionInfections and infestations | 0/30 | 1/29 |
| AcidosisMetabolism and nutrition disorders | 0/30 | 1/29 |
| Acute kidney injuryRenal and urinary disorders | 0/30 | 1/29 |
| Self-ExtubationRespiratory, thoracic and mediastinal disorders | 0/30 | 1/29 |
| Post COVID FibrosisRespiratory, thoracic and mediastinal disorders | 0/30 | 1/29 |
| HypoglycemiaEndocrine disorders | 1/30 | 0/29 |
| BleedingGastrointestinal disorders | 1/30 | 0/29 |
| Event | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 |
|---|---|---|
| Lymphocyte count decreasedInvestigations | 4/30 | 7/29 |
| HypoalbuminemiaMetabolism and nutrition disorders | 2/30 | 3/29 |
| AnemiaBlood and lymphatic system disorders | 0/30 | 3/29 |
| HypocalcemiaMetabolism and nutrition disorders | 0/30 | 2/29 |
| HypokalemiaMetabolism and nutrition disorders | 2/30 | 1/29 |
| Thromboembolic eventVascular disorders | 2/30 | 0/29 |
| Age, Continuous(years) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 | Total |
|---|---|---|---|
| Mean | 54.3 ± 13.5 | 57.0 ± 14.1 | 55.6 ± 13.7 |
| Sex: Female, Male(Participants) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 | Total |
|---|---|---|---|
| Female | 8 | 4 | 12 |
| Male | 22 | 25 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 | Total |
|---|---|---|---|
| Hispanic or Latino | 18 | 17 | 35 |
| Not Hispanic or Latino | 12 | 12 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 12 | 11 | 23 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 12 | 11 | 23 |
| Region of Enrollment(participants) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 | Total |
|---|---|---|---|
| United States | 30 | 29 | 59 |
| Score on Ordinal Scale(Participants) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 | Total |
|---|---|---|---|
| Requiring supplemental oxygen | 11 | 12 | 23 |
| Noninvasive ventilation or high-flow oxygen devices | 17 | 15 | 32 |
| Invasive mechanical ventilation or extracorporeal membrane oxygen | 2 | 2 | 4 |
| Medication for COVID-19 other than the study drug(participants) | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 | Total |
|---|---|---|---|
| Remdesivir | 30 | 29 | 59 |
| Dexamethasone or other steroids (methylprednisolone and prednisone) | 30 | 29 | 59 |
| Convalescent plasma or monoclonal antibodies | 12 | 13 | 25 |
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