Fostamatinib for Hospitalized Adults With COVID-19

NCT04579393 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 10000110000110-H
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Coronavirus Disease 2019

Keywords

SARS-CoV-2; Cytokines; Spleen Tyrosine Kinase; ARDS

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least 1 Serious Adverse Event

  Number of participants with at least 1 serious adverse event by day 29 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.

  Day 29

Secondary Outcomes (19)

• Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less

  day 29

• Number of Participants Who Progress to Mechanical Ventilation

  day 29

• Number of Participants With Cumulative Clinical Endpoint of Death

  day 14, day 28, day 60

• Number of Grade 3 and 4 Adverse Events Through Day 60

  Day 60

• Participant Score on Ordinal Scale

  Day 15, Day 29

Study Arms (2)

Intervention

ACTIVE COMPARATOR

fostamatinib in combination with standard of care (SOC) for the treatment of COVID-19

Drug: fostamatinib

Intervention - Placebo

PLACEBO COMPARATOR

Placebo in combination with standard of care (SOC) for the treatment of COVID-19

Drug: Placebo

Interventions

Placebo DRUG

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

Intervention - Placebo

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

INOVA Health Systems

Falls Church, Virginia, 22042, United States

Location

Related Publications (2)

• Strich JR, Tian X, Samour M, King CS, Shlobin O, Reger R, Cohen J, Ahmad K, Brown AW, Khangoora V, Aryal S, Migdady Y, Kyte JJ, Joo J, Hays R, Collins AC, Battle E, Valdez J, Rivero J, Kim IH, Erb-Alvarez J, Shalhoub R, Chakraborty M, Wong S, Colton B, Ramos-Benitez MJ, Warner S, Chertow DS, Olivier KN, Aue G, Davey RT, Suffredini AF, Childs RW, Nathan SD. Fostamatinib for the Treatment of Hospitalized Adults With Coronavirus Disease 2019: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):e491-e498. doi: 10.1093/cid/ciab732.

  PMID: 34467402 DERIVED

• Strich JR, Ramos-Benitez MJ, Randazzo D, Stein SR, Babyak A, Davey RT, Suffredini AF, Childs RW, Chertow DS. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. J Infect Dis. 2021 Mar 29;223(6):981-984. doi: 10.1093/infdis/jiaa789.

  PMID: 33367731 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jeffrey Strich, MD
• Organization: The National Institutes of Health / The National Heart, Lung, and Blood Institute

jeffrey.strich@nih.gov

301.496.9320

Study Officials

• Jeffrey R Strich, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 8, 2020
• Study Start: October 8, 2020
• Primary Completion: March 30, 2021
• Study Completion: April 30, 2021
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2021-05

Locations

US (2)