Phase 2
Completed N=59
Fostamatinib for Hospitalized Adults With COVID-19
Source: ClinicalTrials.gov NCT04579393 ↗Enrolled (actual)
59
Serious AEs
25.4%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With at Least 1 Serious Adverse Event — 3; 6 Participants
Summary
Background:
COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19.
Objective:
To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes.
Eligibility:
Adults age 18 and older who are hospitalized with COVID-19.
Design:
Participants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed.
Participants will be randomly assigned, to take either fostamatinib pills or a placebo twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit.
Participation will last for about two months
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least 1 Serious Adverse Event |
3; 6 | — |
| SECONDARY Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less |
27; 22 | — |
| SECONDARY Number of Participants Who Progress to Mechanical Ventilation |
1; 2 | — |
| SECONDARY Number of Participants With Cumulative Clinical Endpoint of Death |
0; 1; 0; 3; 1; 3 | — |
| SECONDARY Number of Grade 3 and 4 Adverse Events Through Day 60 |
17; 23; 3; 7 | — |
| SECONDARY Participant Score on Ordinal Scale |
1; 2; 1; 1 | — |
| SECONDARY Change in C-Reactive Protein Levels From Baseline |
-37; -46; -34; -51; -56; -66 | — |
| SECONDARY Change in Fibrinogen Levels From Baseline. |
-60; -65; -86; -78; -130; -96 | — |
| SECONDARY Change in D-Dimer Levels From Baseline |
-0.01; -0.08; -0.06; -0.1; -0.15; -0.24 | — |
| SECONDARY Change in Ferritin Levels From Baseline |
-94; -190; -213; -199; -73; -253 | — |
| SECONDARY Change in Interleukin 6 (IL6) Levels From Baseline |
-0.7; 1.4; -1; 0.3; 0; -2.5 | — |
| SECONDARY Median Days Participants Were Admitted to Intensive Care Unit |
3; 7 | — |
| SECONDARY Relative Change in SpO2/FiO2 Ratio |
0.87; 0.93; 1.09; 0.88; 0.75; 1.09 | — |
| SECONDARY Change in SOFA Score From Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Median Days on Participants Received Supplemental Oxygen |
8; 20 | — |
| SECONDARY The Number of Participants That Experienced Acute Renal Failure |
3; 5 | — |
| SECONDARY Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) |
2; 0 | — |
| SECONDARY Change in Absolute Lymphocyte Count Levels From Baseline |
0.43; 0.13; 0.48; 0.38; 0.41; 0.34 | — |
| SECONDARY Change in Absolute Neutrophil Count Levels From Baseline |
0.04; -0.09; 1.53; 0.94; 0.63; 2.74 | — |
| SECONDARY Change in Platelet Count Levels From Baseline |
59; 58; 103; 63; 145; 62 | — |
Eligibility Criteria
- INCLUSION CRITERIA:
- Patient must be hospitalized, or had their inpatient stay extended, for COVID-19.
- Age >=18 years
- Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
- Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- Females of childbearing potential must agree to be abstinent or use a medical acceptable form of contraception from the time of enrollment through 30 days after last day of study drug
- Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment
- Illness of any duration with SpO2 of less than 94% on room air requiring supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or mechanical ventilation or ECMO (5 to 7 on the 8-point scale)
EXCLUSION CRITERIA
- ALT or AST > 5 times the upper limit of normal (ULN) or ALT or AST >= 3 x ULN and total bilirubin > 2 x ULN.
- Estimated glomerular filtration rate (eGFR) 160mmHg or diastolic blood pressure >100mmHg)
- Shock or hypotension at the time of enrollment
- Neutrophil count <1000/microliter
- Concern for bacterial or fungal sepsis
- Received immunomodulatory treatment within 30 days prior to enrollment e.g., Bruton's tyrosine kinase/phosphoinositide 3 kinase/Janus kinase inhibitor or cytokine-targeting biologic therapy (anti-TNF, IL-6)
- Received a live vaccine the last 4 weeks
- Those who were cognitively impaired or mentally disabled prior to COVID diagnosis
- Participation in another clinical trial for the treatment of COVID-19.
Data sourced from ClinicalTrials.gov (NCT04579393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.