Trial Outcomes & Findings for Fostamatinib for Hospitalized Adults With COVID-19 (NCT NCT04579393)
NCT ID: NCT04579393
Last Updated: 2022-03-02
Results Overview
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.
COMPLETED
PHASE2
59 participants
Day 29
2022-03-02
Participant Flow
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).
Participant milestones
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
27
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Death
|
1
|
3
|
Baseline Characteristics
Fostamatinib for Hospitalized Adults With COVID-19
Baseline characteristics by cohort
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 13.5 • n=93 Participants
|
57.0 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
55.6 years
STANDARD_DEVIATION 13.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
29 participants
n=4 Participants
|
59 participants
n=27 Participants
|
|
Score on Ordinal Scale
Requiring supplemental oxygen
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Score on Ordinal Scale
Noninvasive ventilation or high-flow oxygen devices
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Score on Ordinal Scale
Invasive mechanical ventilation or extracorporeal membrane oxygen
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Medication for COVID-19 other than the study drug
Remdesivir
|
30 participants
n=93 Participants
|
29 participants
n=4 Participants
|
59 participants
n=27 Participants
|
|
Medication for COVID-19 other than the study drug
Dexamethasone or other steroids (methylprednisolone and prednisone)
|
30 participants
n=93 Participants
|
29 participants
n=4 Participants
|
59 participants
n=27 Participants
|
|
Medication for COVID-19 other than the study drug
Convalescent plasma or monoclonal antibodies
|
12 participants
n=93 Participants
|
13 participants
n=4 Participants
|
25 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Intention-to-treat analysis
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.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Number of Participants With at Least 1 Serious Adverse Event
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: day 29Time 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.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less
|
27 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: day 29Population: Participants who were not receiving mechanical ventilation at baseline
Number of participants who progress to mechanical ventilation by day 29
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=28 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=27 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Number of Participants Who Progress to Mechanical Ventilation
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: day 14, day 28, day 60Population: Intention-to-treat analysis
Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Number of Participants With Cumulative Clinical Endpoint of Death
day 28
|
0 Participants
|
3 Participants
|
|
Number of Participants With Cumulative Clinical Endpoint of Death
day 60
|
1 Participants
|
3 Participants
|
|
Number of Participants With Cumulative Clinical Endpoint of Death
day 14
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 60Population: Intention-to-treat analysis
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.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Number of Grade 3 and 4 Adverse Events Through Day 60
Grade 4
|
3 Adverse Events
|
7 Adverse Events
|
|
Number of Grade 3 and 4 Adverse Events Through Day 60
Grade 3
|
17 Adverse Events
|
23 Adverse Events
|
SECONDARY outcome
Timeframe: Day 15, Day 29Population: intent to treat analysis
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.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Participant Score on Ordinal Scale
Day 15
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 5.0
|
|
Participant Score on Ordinal Scale
Day 29
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter).
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in C-Reactive Protein Levels From Baseline
Day 3
|
-37 mg/L (milligrams per liter)
Interval -94.0 to -6.0
|
-46 mg/L (milligrams per liter)
Interval -105.0 to -1.0
|
|
Change in C-Reactive Protein Levels From Baseline
Day 29
|
-65 mg/L (milligrams per liter)
Interval -117.0 to -33.0
|
-106 mg/L (milligrams per liter)
Interval -155.0 to -57.0
|
|
Change in C-Reactive Protein Levels From Baseline
Day 5
|
-34 mg/L (milligrams per liter)
Interval -84.0 to 5.0
|
-51 mg/L (milligrams per liter)
Interval -128.0 to -23.0
|
|
Change in C-Reactive Protein Levels From Baseline
Day 8
|
-56 mg/L (milligrams per liter)
Interval -108.0 to -17.0
|
-66 mg/L (milligrams per liter)
Interval -118.0 to -39.0
|
|
Change in C-Reactive Protein Levels From Baseline
Day 11
|
-52 mg/L (milligrams per liter)
Interval -114.0 to -29.0
|
-68 mg/L (milligrams per liter)
Interval -139.0 to -46.0
|
|
Change in C-Reactive Protein Levels From Baseline
Day 15
|
-43 mg/L (milligrams per liter)
Interval -109.0 to -33.0
|
-71 mg/L (milligrams per liter)
Interval -126.0 to -47.0
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL).
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in Fibrinogen Levels From Baseline.
Day 3
|
-60 mg/dL (milligrams per decilitre)
Interval -177.0 to -11.0
|
-65 mg/dL (milligrams per decilitre)
Interval -155.0 to 41.0
|
|
Change in Fibrinogen Levels From Baseline.
Day 15
|
-132 mg/dL (milligrams per decilitre)
Interval -182.0 to -24.0
|
-76 mg/dL (milligrams per decilitre)
Interval -214.0 to 10.0
|
|
Change in Fibrinogen Levels From Baseline.
Day 29
|
-113 mg/dL (milligrams per decilitre)
Interval -235.0 to -63.0
|
-231 mg/dL (milligrams per decilitre)
Interval -351.0 to -64.0
|
|
Change in Fibrinogen Levels From Baseline.
Day 5
|
-86 mg/dL (milligrams per decilitre)
Interval -187.0 to 2.0
|
-78 mg/dL (milligrams per decilitre)
Interval -245.0 to 36.0
|
|
Change in Fibrinogen Levels From Baseline.
Day 8
|
-130 mg/dL (milligrams per decilitre)
Interval -260.0 to -34.0
|
-96 mg/dL (milligrams per decilitre)
Interval -236.0 to -40.0
|
|
Change in Fibrinogen Levels From Baseline.
Day 11
|
-141 mg/dL (milligrams per decilitre)
Interval -277.0 to -77.0
|
-138 mg/dL (milligrams per decilitre)
Interval -250.0 to -14.0
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter).
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in D-Dimer Levels From Baseline
Day 5
|
-0.06 mcg/mL (microgram per milliliter)
Interval -0.24 to 0.11
|
-0.1 mcg/mL (microgram per milliliter)
Interval -0.74 to 0.15
|
|
Change in D-Dimer Levels From Baseline
Day 8
|
-0.15 mcg/mL (microgram per milliliter)
Interval -0.74 to 0.07
|
-0.24 mcg/mL (microgram per milliliter)
Interval -1.25 to 0.1
|
|
Change in D-Dimer Levels From Baseline
Day 3
|
-0.01 mcg/mL (microgram per milliliter)
Interval -0.19 to 0.25
|
-0.08 mcg/mL (microgram per milliliter)
Interval -0.4 to 0.31
|
|
Change in D-Dimer Levels From Baseline
Day 11
|
-0.11 mcg/mL (microgram per milliliter)
Interval -0.56 to 0.12
|
-0.43 mcg/mL (microgram per milliliter)
Interval -0.99 to 0.06
|
|
Change in D-Dimer Levels From Baseline
Day 15
|
-0.06 mcg/mL (microgram per milliliter)
Interval -0.2 to 0.12
|
-0.32 mcg/mL (microgram per milliliter)
Interval -1.02 to 0.0
|
|
Change in D-Dimer Levels From Baseline
Day 29
|
-0.15 mcg/mL (microgram per milliliter)
Interval -0.31 to 0.0
|
-0.16 mcg/mL (microgram per milliliter)
Interval -0.82 to 0.46
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter).
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in Ferritin Levels From Baseline
Day 3
|
-94 mcg/L (micrograms per liter)
Interval -306.0 to 20.0
|
-190 mcg/L (micrograms per liter)
Interval -622.0 to -102.0
|
|
Change in Ferritin Levels From Baseline
Day 5
|
-213 mcg/L (micrograms per liter)
Interval -532.0 to -25.0
|
-199 mcg/L (micrograms per liter)
Interval -684.0 to 16.0
|
|
Change in Ferritin Levels From Baseline
Day 8
|
-73 mcg/L (micrograms per liter)
Interval -428.0 to 438.0
|
-253 mcg/L (micrograms per liter)
Interval -586.0 to -17.0
|
|
Change in Ferritin Levels From Baseline
Day 11
|
-169 mcg/L (micrograms per liter)
Interval -853.0 to 93.0
|
-491 mcg/L (micrograms per liter)
Interval -756.0 to -239.0
|
|
Change in Ferritin Levels From Baseline
Day 15
|
-346 mcg/L (micrograms per liter)
Interval -904.0 to 4.0
|
-561 mcg/L (micrograms per liter)
Interval -882.0 to -350.0
|
|
Change in Ferritin Levels From Baseline
D29
|
-578 mcg/L (micrograms per liter)
Interval -1038.0 to -206.0
|
-738 mcg/L (micrograms per liter)
Interval -1562.0 to -530.0
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Change in Interleukin 6 (IL6) blood levels from baseline. The upper limit of normal for IL6 is 1.8 picograms per milliliter (pg/mL).
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in Interleukin 6 (IL6) Levels From Baseline
Day 11
|
-0.1 pg/mL (picograms per milliliter)
Interval -9.9 to 1.4
|
-0.3 pg/mL (picograms per milliliter)
Interval -8.2 to 0.3
|
|
Change in Interleukin 6 (IL6) Levels From Baseline
Day 15
|
-1.5 pg/mL (picograms per milliliter)
Interval -5.5 to 1.0
|
-0.7 pg/mL (picograms per milliliter)
Interval -4.3 to 0.5
|
|
Change in Interleukin 6 (IL6) Levels From Baseline
Day 3
|
-0.7 pg/mL (picograms per milliliter)
Interval -11.5 to 1.4
|
1.4 pg/mL (picograms per milliliter)
Interval -2.6 to 6.9
|
|
Change in Interleukin 6 (IL6) Levels From Baseline
Day 5
|
-1 pg/mL (picograms per milliliter)
Interval -16.1 to 4.4
|
0.3 pg/mL (picograms per milliliter)
Interval -1.8 to 4.5
|
|
Change in Interleukin 6 (IL6) Levels From Baseline
Day 8
|
0 pg/mL (picograms per milliliter)
Interval -5.5 to 3.8
|
-2.5 pg/mL (picograms per milliliter)
Interval -6.6 to 0.0
|
|
Change in Interleukin 6 (IL6) Levels From Baseline
Day 29
|
-1.4 pg/mL (picograms per milliliter)
Interval -6.5 to -0.4
|
-1.4 pg/mL (picograms per milliliter)
Interval -4.0 to -0.8
|
SECONDARY outcome
Timeframe: Day 29Population: Participants admitted to Intensive Care Unit
Median days participants were admitted to Intensive Care Unit (ICU) by day 29
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=13 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=12 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Median Days Participants Were Admitted to Intensive Care Unit
|
3 Days
Interval 2.0 to 5.0
|
7 Days
Interval 2.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Only SpO2/FiO2 ratio is available as PaO2 was not consistently measured. Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Relative change in PaO2/FiO2 or SpO2/FiO2 ratio.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Relative Change in SpO2/FiO2 Ratio
Day 29
|
0.74 SpO2/FiO2 ratio
Interval 0.74 to 0.74
|
0.49 SpO2/FiO2 ratio
Interval 0.42 to 0.97
|
|
Relative Change in SpO2/FiO2 Ratio
Day 3
|
0.87 SpO2/FiO2 ratio
Interval 0.7 to 0.97
|
0.93 SpO2/FiO2 ratio
Interval 0.65 to 1.04
|
|
Relative Change in SpO2/FiO2 Ratio
Day 5
|
1.09 SpO2/FiO2 ratio
Interval 0.75 to 1.33
|
0.88 SpO2/FiO2 ratio
Interval 0.76 to 1.08
|
|
Relative Change in SpO2/FiO2 Ratio
Day 8
|
0.75 SpO2/FiO2 ratio
Interval 0.59 to 1.83
|
1.09 SpO2/FiO2 ratio
Interval 0.59 to 1.39
|
|
Relative Change in SpO2/FiO2 Ratio
Day 11
|
1.49 SpO2/FiO2 ratio
Interval 0.81 to 2.14
|
0.99 SpO2/FiO2 ratio
Interval 0.53 to 1.59
|
|
Relative Change in SpO2/FiO2 Ratio
Day 15
|
1.23 SpO2/FiO2 ratio
Interval 0.87 to 1.5
|
1.07 SpO2/FiO2 ratio
Interval 0.67 to 1.79
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
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.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in SOFA Score From Baseline
Day 11
|
0 score on a SOFA scale
Interval -1.0 to 0.0
|
0 score on a SOFA scale
Interval 0.0 to 2.0
|
|
Change in SOFA Score From Baseline
Day 3
|
0 score on a SOFA scale
Interval 0.0 to 0.0
|
0 score on a SOFA scale
Interval -1.0 to 0.0
|
|
Change in SOFA Score From Baseline
Day 5
|
0 score on a SOFA scale
Interval -1.0 to 0.0
|
0 score on a SOFA scale
Interval 0.0 to 0.0
|
|
Change in SOFA Score From Baseline
Day 8
|
0 score on a SOFA scale
Interval -1.0 to 1.0
|
0 score on a SOFA scale
Interval -1.0 to 0.0
|
|
Change in SOFA Score From Baseline
Day 15
|
-1 score on a SOFA scale
Interval -2.0 to 0.0
|
0 score on a SOFA scale
Interval -1.0 to 2.0
|
|
Change in SOFA Score From Baseline
Day 29
|
0 score on a SOFA scale
Interval 0.0 to 0.0
|
1 score on a SOFA scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: day 29Median days on participants received supplemental oxygen through day 29
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Median Days on Participants Received Supplemental Oxygen
|
8 days
Interval 5.0 to 10.0
|
20 days
Interval 14.0 to 27.0
|
SECONDARY outcome
Timeframe: day 29Population: Intent to treat analysis
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.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
The Number of Participants That Experienced Acute Renal Failure
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: day 29Population: Intent to Treat Analysis.
Number of participants that experienced a deep vein thrombosis (DVT) or pulmonary embolism (PE) by day 29
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Change in Absolute lymphocyte count blood levels from baseline.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in Absolute Lymphocyte Count Levels From Baseline
Day 29
|
0.56 thousand cells per microliter
Interval 0.42 to 0.89
|
0.81 thousand cells per microliter
Interval 0.42 to 1.38
|
|
Change in Absolute Lymphocyte Count Levels From Baseline
Day 3
|
0.43 thousand cells per microliter
Interval 0.02 to 0.64
|
0.13 thousand cells per microliter
Interval -0.18 to 0.42
|
|
Change in Absolute Lymphocyte Count Levels From Baseline
Day 5
|
0.48 thousand cells per microliter
Interval 0.08 to 1.03
|
0.38 thousand cells per microliter
Interval -0.14 to 0.73
|
|
Change in Absolute Lymphocyte Count Levels From Baseline
Day 8
|
0.41 thousand cells per microliter
Interval 0.06 to 1.22
|
0.34 thousand cells per microliter
Interval -0.02 to 1.09
|
|
Change in Absolute Lymphocyte Count Levels From Baseline
Day 11
|
1.03 thousand cells per microliter
Interval 0.15 to 1.37
|
1.02 thousand cells per microliter
Interval 0.57 to 1.44
|
|
Change in Absolute Lymphocyte Count Levels From Baseline
Day 15
|
1.03 thousand cells per microliter
Interval 0.52 to 1.18
|
0.68 thousand cells per microliter
Interval 0.25 to 1.07
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Change in Absolute neutrophil count blood levels from baseline.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in Absolute Neutrophil Count Levels From Baseline
Day 3
|
0.04 thousand cells per microliter
Interval -1.22 to 1.06
|
-0.09 thousand cells per microliter
Interval -2.06 to 1.88
|
|
Change in Absolute Neutrophil Count Levels From Baseline
Day 8
|
0.63 thousand cells per microliter
Interval -3.4 to 3.78
|
2.74 thousand cells per microliter
Interval -0.4 to 6.26
|
|
Change in Absolute Neutrophil Count Levels From Baseline
Day 11
|
-0.95 thousand cells per microliter
Interval -2.34 to 1.1
|
0.85 thousand cells per microliter
Interval -1.42 to 2.6
|
|
Change in Absolute Neutrophil Count Levels From Baseline
Day 15
|
-1.77 thousand cells per microliter
Interval -3.41 to -0.6
|
-1.6 thousand cells per microliter
Interval -5.22 to 1.61
|
|
Change in Absolute Neutrophil Count Levels From Baseline
Day 5
|
1.53 thousand cells per microliter
Interval -2.31 to 2.5
|
0.94 thousand cells per microliter
Interval -0.97 to 2.1
|
|
Change in Absolute Neutrophil Count Levels From Baseline
Day 29
|
-2.54 thousand cells per microliter
Interval -4.62 to -1.12
|
-2.89 thousand cells per microliter
Interval -7.9 to -0.22
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
Change in Platelet count blood levels from baseline.
Outcome measures
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=29 Participants
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 Participants
Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Change in Platelet Count Levels From Baseline
Day 15
|
11 thousand cells per microliter
Interval -30.0 to 92.0
|
-26 thousand cells per microliter
Interval -198.0 to 26.0
|
|
Change in Platelet Count Levels From Baseline
Day 29
|
-29 thousand cells per microliter
Interval -87.0 to 42.0
|
-7 thousand cells per microliter
Interval -102.0 to 60.0
|
|
Change in Platelet Count Levels From Baseline
Day 3
|
59 thousand cells per microliter
Interval 19.0 to 117.0
|
58 thousand cells per microliter
Interval 24.0 to 103.0
|
|
Change in Platelet Count Levels From Baseline
Day 5
|
103 thousand cells per microliter
Interval 55.0 to 150.0
|
63 thousand cells per microliter
Interval 1.0 to 142.0
|
|
Change in Platelet Count Levels From Baseline
Day 8
|
145 thousand cells per microliter
Interval 91.0 to 217.0
|
62 thousand cells per microliter
Interval -34.0 to 171.0
|
|
Change in Platelet Count Levels From Baseline
Day 11
|
80 thousand cells per microliter
Interval 20.0 to 156.0
|
25 thousand cells per microliter
Interval -132.0 to 128.0
|
Adverse Events
Fostamatinib With Standard of Care for Treatment of COVID-19
Placebo With Standard of Care for Treatment of COVID-19
Serious adverse events
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 participants at risk
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 participants at risk
Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/29 • 60 days
|
|
Gastrointestinal disorders
Bleeding
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/29 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
2/30 • Number of events 2 • 60 days
|
10.3%
3/29 • Number of events 3 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
3.3%
1/30 • Number of events 1 • 60 days
|
0.00%
0/29 • 60 days
|
|
General disorders
Multi-organ failure
|
0.00%
0/30 • 60 days
|
3.4%
1/29 • Number of events 1 • 60 days
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/30 • 60 days
|
3.4%
1/29 • Number of events 1 • 60 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/30 • 60 days
|
3.4%
1/29 • Number of events 1 • 60 days
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/30 • 60 days
|
3.4%
1/29 • Number of events 1 • 60 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/30 • 60 days
|
3.4%
1/29 • Number of events 1 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Self-Extubation
|
0.00%
0/30 • 60 days
|
3.4%
1/29 • Number of events 1 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Post COVID Fibrosis
|
0.00%
0/30 • 60 days
|
3.4%
1/29 • Number of events 1 • 60 days
|
Other adverse events
| Measure |
Fostamatinib With Standard of Care for Treatment of COVID-19
n=30 participants at risk
Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
Placebo With Standard of Care for Treatment of COVID-19
n=29 participants at risk
Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses.
|
|---|---|---|
|
Investigations
Lymphocyte count decreased
|
13.3%
4/30 • Number of events 4 • 60 days
|
24.1%
7/29 • Number of events 7 • 60 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
2/30 • Number of events 2 • 60 days
|
10.3%
3/29 • Number of events 3 • 60 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
2/30 • Number of events 2 • 60 days
|
3.4%
1/29 • Number of events 1 • 60 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/30 • 60 days
|
10.3%
3/29 • Number of events 3 • 60 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/30 • 60 days
|
6.9%
2/29 • Number of events 2 • 60 days
|
|
Vascular disorders
Thromboembolic event
|
6.7%
2/30 • Number of events 2 • 60 days
|
0.00%
0/29 • 60 days
|
Additional Information
Jeffrey Strich, MD
The National Institutes of Health / The National Heart, Lung, and Blood Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place