Fostamatinib for Hospitalized Adults With COVID-19

Conditions

• Coronavirus Disease 2019

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo tablets to match fostamatinib 100 mg and 150 mg will be provided.
• fostamatinib — DRUG
  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.

Study Details

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 Dates

Start date

Oct 8, 2020

Status verified

May 2021

Primary completion

Mar 30, 2021

Completion

Apr 30, 2021

Study Design

Enrollment

59 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Intervention
  fostamatinib in combination with standard of care (SOC) for the treatment of COVID-19
• Placebo Comparator: Intervention - Placebo
  Placebo in combination with standard of care (SOC) for the treatment of COVID-19

Primary Outcome Measure

Number of Participants With at Least 1 Serious Adverse Event [ Time Frame: Day 29 ]

Locations (2)

Find similar trials in Bethesda, MD

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