Fostamatinib for Hospitalized Adults With COVID-19

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronavirus Disease 2019

In brief

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

Key facts

Study ID

NCT04579393

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

59

Starts

2020-10-08

Expected to finish

2021-04-30

Last updated by the study team

2022-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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) <30ml/min
• Pregnancy or breast feeding
• Anticipated discharge in the next 72 hours
• Allergy to study medication
• Uncontrolled hypertension (systolic blood pressure >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.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• INOVA Health Systems — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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