| Primary | Oxygen Free Days Through Day 28 | 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). | 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 | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 28 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00013.4± 12.4
- OG00114.2± 12.1
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| Secondary | In-hospital Mortality | Number of patients who die during hospitalization | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 1 to hospital discharge or Day 90 whichever comes first | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Alive and Oxygen Free at Day 14 | 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). | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 1 to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Alive and Oxygen Free at Day 28 | 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) | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 1 to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Number of patients alive free of new invasive mechanical ventilation at day 28 | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 1 to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | 28-day Mortality | Number of patients who have died at Day 28 | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | 60-day Mortality | Number of patients who have died at Day 60 | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 60 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | 90-day Mortality | Number of participants mortality at Day 90 | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14 | Number of participants who fell within the ordinal scale per the below criteria. A higher score indicates a worse outcome.
- Ambulatory - Not hospitalized and no limitation of activities
- Ambulatory - Not hospitalized with limitation of activities or home oxygen use
- Hospitalized Mild Disease - Hospitalized, no oxygen therapy
- Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
- Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
- Hospitalized Severe Disease -Invasive mechanical ventilation
- Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
- Dead
| Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | The number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome
- Ambulatory - Not hospitalized and no limitation of activities
- Ambulatory - Not hospitalized with limitation of activities or home oxygen use
- Hospitalized Mild Disease - Hospitalized, no oxygen therapy
- Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
- Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
- Hospitalized Severe Disease -Invasive mechanical ventilation
- Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
- Dead
| Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome
- Ambulatory - Not hospitalized and no limitation of activities
- Ambulatory - Not hospitalized with limitation of activities or home oxygen use
- Hospitalized Mild Disease - Hospitalized, no oxygen therapy
- Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
- Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
- Hospitalized Severe Disease -Invasive mechanical ventilation
- Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
- Dead
| Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Count of Participants | | Participants | | Day 60 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Hospital-free Days Through Day 28 | 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. | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded. | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Ventilator-free Days Through Day 28 | 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. | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Respiratory Failure-free Days Through Day 28 | 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. | Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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