Fostamatinib for Hospitalized Adults With COVID-19
Condition: Coronavirus Disease 2019
MeSH terms: COVID-19
Intervention: Placebo; fostamatinib
Intervention description: Placebo tablets to match fostamatinib 100 mg and 150 mg will be provided.; The study intervention is fostamatinib, an inhibitor of spleen tyrosine kinase that will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. Subjects will receive standard of care and be randomized to receive fostamatinib or matching placebo.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; Cytokines; Spleen Tyrosine Kinase; ARDS

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
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Patient must be hospitalized, or had their inpatient stay extended, for COVID-19.

               2. Age >=18 years

               3. Subject (or legally authorized representative) provides informed consent prior to
                  initiation of any study procedures.

               4. Subject (or legally authorized representative) understands and agrees to comply
                  with planned study procedures.

               5. 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

               6. Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment

               7. 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:

          1. ALT or AST > 5 times the upper limit of normal (ULN) or ALT or AST >= 3 x ULN and
             total bilirubin > 2 x ULN.

          2. Estimated glomerular filtration rate (eGFR) <30ml/min

          3. Pregnancy or breast feeding

          4. Anticipated discharge in the next 72 hours

          5. Allergy to study medication

          6. Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood
             pressure >100mmHg)

          7. Shock or hypotension at the time of enrollment

          8. Neutrophil count <1000/microliter

          9. Concern for bacterial or fungal sepsis

         10. 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)

         11. Received a live vaccine the last 4 weeks

         12. Those who were cognitively impaired or mentally disabled prior to COVID diagnosis

         13. Participation in another clinical trial for the treatment of COVID-19.