International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response

Sponsor
NEAT ID Foundation
Study ID
NCT05593770
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

  • COVID-19
  • Coronavirus Infection
  • SARS-CoV2 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fostamatinib — DRUG
    Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
  • Placebo — DRUG
    Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.

Study Details

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.

Key Dates

Start date
Oct 27, 2022
Status verified
Apr 2025
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fostamatinib
    An investigational oral spleen tyrosine kinase inhibitor.
  • Placebo Comparator: Placebo
    Orange film-coated, plain, bioconvex tablets for fostamatinib. For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.

Primary Outcome Measure

Oxygen Free Days Through Day 28 [ Time Frame: Day 1 to Day 28 ]

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