Trial · NCT04579393
Fostamatinib for Hospitalized Adults With COVID-19
NCT04579393, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2022-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fostamatinib for Hospitalized Adults With COVID-19. Trials, record NCT04579393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04579393
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fostamatinib for Hospitalized Adults With COVID-19
- NCT number
- NCT04579393
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Coronavirus Disease 2019
- Interventions
- Placebo, fostamatinib
- First posted
- 2020-10-08
- Last updated
- 2022-03-02
- Results first posted
- 2022-03-02
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least 1 Serious Adverse Event | 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. |
| Secondary | Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | day 29 | 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. |
| Secondary | Number of Participants Who Progress to Mechanical Ventilation | day 29 | Number of participants who progress to mechanical ventilation by day 29 |
| Secondary | Number of Participants With Cumulative Clinical Endpoint of Death | day 14, day 28, day 60 | Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60 |
| Secondary | Number of Grade 3 and 4 Adverse Events Through Day 60 | 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. |
| Secondary | Participant Score on Ordinal Scale | Day 15, Day 29 | 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. |
| Secondary | Change in C-Reactive Protein Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter). |
| Secondary | Change in Fibrinogen Levels From Baseline. | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL). |
| Secondary | Change in D-Dimer Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter). |
| Secondary | Change in Ferritin Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least 1 Serious Adverse Event | Day 29 | Intention-to-treat analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | day 29 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Progress to Mechanical Ventilation | day 29 | Participants who were not receiving mechanical ventilation at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cumulative Clinical Endpoint of Death | day 14, day 28, day 60 | Intention-to-treat analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Grade 3 and 4 Adverse Events Through Day 60 | Day 60 | Intention-to-treat analysis | Adverse Events | NUMBER |
| SECONDARY | Participant Score on Ordinal Scale | Day 15, Day 29 | intent to treat analysis | score on a scale | MEDIAN |
| SECONDARY | Change in C-Reactive Protein Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | 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. | mg/L (milligrams per liter) | MEDIAN |
| SECONDARY | Change in Fibrinogen Levels From Baseline. | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | 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. | mg/dL (milligrams per decilitre) | MEDIAN |
| SECONDARY | Change in D-Dimer Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | 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. | mcg/mL (microgram per milliliter) | MEDIAN |
| SECONDARY | Change in Ferritin Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | 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. | mcg/L (micrograms per liter) | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group148
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least 1 Serious Adverse Event | Fostamatinib With Standard of Care for Treatment of COVID-19 | 3 | Participants | ||
| Number of Participants With at Least 1 Serious Adverse Event | Placebo With Standard of Care for Treatment of COVID-19 | 6 | Participants | ||
| Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | Fostamatinib With Standard of Care for Treatment of COVID-19 | 27 | Participants | ||
| Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | Placebo With Standard of Care for Treatment of COVID-19 | 22 | Participants | ||
| Number of Participants Who Progress to Mechanical Ventilation | Fostamatinib With Standard of Care for Treatment of COVID-19 | 1 | Participants | ||
| Number of Participants Who Progress to Mechanical Ventilation | Placebo With Standard of Care for Treatment of COVID-19 | 2 | Participants | ||
| Number of Participants With Cumulative Clinical Endpoint of Death | Fostamatinib With Standard of Care for Treatment of COVID-19 | day 14 | 0 | Participants | |
| Number of Participants With Cumulative Clinical Endpoint of Death | Placebo With Standard of Care for Treatment of COVID-19 | day 14 | 1 | Participants | |
| Number of Participants With Cumulative Clinical Endpoint of Death | Fostamatinib With Standard of Care for Treatment of COVID-19 | day 28 | 0 | Participants | |
| Number of Participants With Cumulative Clinical Endpoint of Death | Placebo With Standard of Care for Treatment of COVID-19 | day 28 | 3 | Participants |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fostamatinib With Standard of Care for Treatment of COVID-19 | 30 | |
| Overall Study | STARTED | Placebo With Standard of Care for Treatment of COVID-19 | 29 | |
| Overall Study | COMPLETED | Fostamatinib With Standard of Care for Treatment of COVID-19 | 27 | |
| Overall Study | COMPLETED | Placebo With Standard of Care for Treatment of COVID-19 | 24 | |
| Overall Study | NOT COMPLETED | Fostamatinib With Standard of Care for Treatment of COVID-19 | 3 | |
| Overall Study | NOT COMPLETED | Placebo With Standard of Care for Treatment of COVID-19 | 5 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphocyte count decreased | Investigations | Fostamatinib With Standard of Care for Treatment of COVID-19 | 4 | 30 | 4 |
| other | Lymphocyte count decreased | Investigations | Placebo With Standard of Care for Treatment of COVID-19 | 7 | 29 | 7 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Fostamatinib With Standard of Care for Treatment of COVID-19 | 2 | 30 | 2 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Placebo With Standard of Care for Treatment of COVID-19 | 3 | 29 | 3 |
| other | Hypokalemia | Metabolism and nutrition disorders | Fostamatinib With Standard of Care for Treatment of COVID-19 | 2 | 30 | 2 |
| other | Hypokalemia | Metabolism and nutrition disorders | Placebo With Standard of Care for Treatment of COVID-19 | 1 | 29 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Fostamatinib With Standard of Care for Treatment of COVID-19 | 0 | 30 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Placebo With Standard of Care for Treatment of COVID-19 | 3 | 29 | 3 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Fostamatinib With Standard of Care for Treatment of COVID-19 | 0 | 30 | 0 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Placebo With Standard of Care for Treatment of COVID-19 | 2 | 29 | 2 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fostamatinib With Standard of Care for Treatment of COVID-19 | 1 | 30 |
| Total, all-cause mortality | Placebo With Standard of Care for Treatment of COVID-19 | 3 | 29 |
| Total, other adverse events | Fostamatinib With Standard of Care for Treatment of COVID-19 | 8 | 30 |
| Total, other adverse events | Placebo With Standard of Care for Treatment of COVID-19 | 15 | 29 |
| Total, serious adverse events | Fostamatinib With Standard of Care for Treatment of COVID-19 | 5 | 30 |
| Total, serious adverse events | Placebo With Standard of Care for Treatment of COVID-19 | 10 | 29 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 vs Placebo With Standard of Care for Treatment of COVID-19: Number of Participants With at Least 1 Serious Adverse Event | Trial comparisons |
| Fostamatinib With Standard of Care for Treatment of COVID-19 vs Placebo With Standard of Care for Treatment of COVID-19: Number of Participants Who Progress to Mechanical Ventilation | Trial comparisons |
Fostamatinib With Standard of Care for Treatment of COVID-19 vs Placebo With Standard of Care for Treatment of COVID-19: Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) | Trial comparisons |
Fostamatinib With Standard of Care for Treatment of COVID-19 vs 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 | Trial comparisons |
| Fostamatinib With Standard of Care for Treatment of COVID-19 vs Placebo With Standard of Care for Treatment of COVID-19: deaths from any cause | Trial comparisons |
| Fostamatinib With Standard of Care for Treatment of COVID-19 vs Placebo With Standard of Care for Treatment of COVID-19: The Number of Participants That Experienced Acute Renal Failure | Trial comparisons |
| Fostamatinib With Standard of Care for Treatment of COVID-19 vs Placebo With Standard of Care for Treatment of COVID-19: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04579393
GET https://conductscience.org/api/trials/v1/NCT04579393/results?page=2