Trial Outcomes & Findings for International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response (NCT NCT05593770)
NCT ID: NCT05593770
Last Updated: 2025-05-02
Results Overview
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
28 participants
Primary outcome timeframe
Day 1 to Day 28
Results posted on
2025-05-02
Participant Flow
Participants were over 18 years old with documented SARS-COV-2 infection confirmed by nucleic acid test. Participants were assigned to receive either the active Fostamatinib drug or matching placebo.
Participant milestones
| Measure |
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response
Baseline characteristics by cohort
| Measure |
Fostamatinib
n=14 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=14 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: The number of participants enrolled by international sites was insufficient for analysis due to the early termination of the trial. This analysis was performed on all participants enrolled to the fostamatinib arm of the ACTIV-4 Host Tissue platform (United states + International sites).The global fostamatinib arm of the ACTIV 4 study enrolled 400 participants, of which 28 were included from international sites and the results are reported in a separate Clinicaltrials.gov record, ref NCT04924660
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Outcome measures
| Measure |
Fostamatinib
n=199 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=201 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Oxygen Free Days Through Day 28
|
13.4 days
Standard Deviation 12.4
|
14.2 days
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Day 1 to hospital discharge or Day 90 whichever comes firstPopulation: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of patients who die during hospitalization
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
In-hospital Mortality
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 14Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Alive and Oxygen Free at Day 14
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of patients oxygen free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Alive and Oxygen Free at Day 28
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of patients alive free of new invasive mechanical ventilation at day 28
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Alive and Free of New Invasive Mechanical Ventilation at Day 28
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of patients who have died at Day 28
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
28-day Mortality
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 60Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of patients who have died at Day 60
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
60-day Mortality
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 90Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of participants mortality at Day 90
Outcome measures
| Measure |
Fostamatinib
n=12 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
90-day Mortality
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of participants who fell within the ordinal scale per the below criteria. A higher score indicates a worse outcome. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Score 1
|
8 Participants
|
6 Participants
|
|
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Score 2
|
3 Participants
|
1 Participants
|
|
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Score 3
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Score 4
|
1 Participants
|
3 Participants
|
|
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Score 5
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Score 6
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Score 7
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Score 8
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
The number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Score 1
|
9 Participants
|
7 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Score 2
|
1 Participants
|
3 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Score 3
|
1 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Score 4
|
1 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Score 5
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Score 6
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Score 7
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Score 8
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 60Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Outcome measures
| Measure |
Fostamatinib
n=11 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Score 1
|
7 Participants
|
7 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Score 2
|
2 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Score 3
|
0 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Score 4
|
1 Participants
|
1 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Score 5
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Score 6
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Score 7
|
0 Participants
|
0 Participants
|
|
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Score 8
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.
Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Hospital-free Days Through Day 28
Spain
|
21.3 days
Standard Deviation 8.2
|
19.5 days
Standard Deviation 12.5
|
|
Hospital-free Days Through Day 28
Brazil
|
-1 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
—
|
|
Hospital-free Days Through Day 28
Germany
|
—
|
0 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
|
Hospital-free Days Through Day 28
Italy
|
14 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
—
|
|
Hospital-free Days Through Day 28
South Africa
|
25.5 days
Standard Deviation 3.5
|
26.5 days
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded
Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Ventilator-free Days Through Day 28
Spain
|
21.3 days
Standard Deviation 8.2
|
19.5 days
Standard Deviation 12.5
|
|
Ventilator-free Days Through Day 28
Brazil
|
-1 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
—
|
|
Ventilator-free Days Through Day 28
Germany
|
—
|
0 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
|
Ventilator-free Days Through Day 28
Italy
|
14 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
—
|
|
Ventilator-free Days Through Day 28
South Africa
|
25.3 days
Standard Deviation 3.5
|
26.5 days
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded
Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1.
Outcome measures
| Measure |
Fostamatinib
n=13 Participants
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=12 Participants
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Respiratory Failure-free Days Through Day 28
South Africa
|
25.3 days
Standard Deviation 3.5
|
26.5 days
Standard Deviation 0.7
|
|
Respiratory Failure-free Days Through Day 28
Spain
|
21.3 days
Standard Deviation 8.2
|
19.5 days
Standard Deviation 12.5
|
|
Respiratory Failure-free Days Through Day 28
Brazil
|
-1 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
—
|
|
Respiratory Failure-free Days Through Day 28
Germany
|
—
|
0 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
|
Respiratory Failure-free Days Through Day 28
Italy
|
14 days
Standard Deviation NA
Unable to provide standard deviation as only 1 participant affected
|
—
|
Adverse Events
Fostamatinib
Serious events: 8 serious events
Other events: 8 other events
Deaths: 1 deaths
Placebo
Serious events: 5 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Fostamatinib
n=14 participants at risk
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=14 participants at risk
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Infections and infestations
Respiratory tract infection
|
7.1%
1/14 • Number of events 2 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
Other adverse events
| Measure |
Fostamatinib
n=14 participants at risk
An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
Placebo
n=14 participants at risk
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Placebo: Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
General disorders
Discomfort
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
General disorders
Injection site phlebitis
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Renal and urinary disorders
Haematuria
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
0.00%
0/14 • Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90
|
Additional Information
Clinical Project Manager
Research Organization (KC) Ltd
Phone: +44 (0) 7494 795 982
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place