Novel Experimental COVID-19 Therapies Affecting Host Response

Conditions

• COVID-19
• Coronavirus Infection
• SARS-CoV-2 Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TXA127 — DRUG
  TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
• TRV027 — DRUG
  TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
• Placebo — DRUG
  NaCl 0.9% infused to match the duration of the agent (3 hours for TXA127 and continuous 24-hour infusion for TRV027, over 30 minutes for APN01. 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.
• 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.

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. The primary analysis will include data from NCT05593770.

Key Dates

Start date

Jul 15, 2021

Status verified

Dec 2024

Primary completion

Oct 25, 2023

Completion

Dec 31, 2023

Study Design

Enrollment

1,060 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TXA127 (4/20/2022 Arm Closed to Accrual)
  An investigational peptide agonist of Mas receptors.
• Experimental: TRV027 (4/20/2022 Arm Closed to Accrual)
  An investigational peptide biased agonist of the AT1 receptor.
• Placebo Comparator: Placebo
  NaCl 0.9% infused to match the duration of the agent for TXA127, TRV027, and APN01. 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.
• Experimental: Fostamatinib
  An investigational oral spleen tyrosine kinase inhibitor.

Primary Outcome Measure

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

Locations (51)

Find similar trials in Birmingham, AL

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