Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04920916
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dupilumab — BIOLOGICAL
    Participants will receive a loading dose of dupilumab (600 mg, given as two 300 mg subcutaneous injections) on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28.
  • Placebo — DRUG
    Normal Saline.

Study Details

This is a randomized, double-blind, placebo-controlled, superiority phase IIa trial to assess the safety and efficacy of dupilumab use in hospitalized patients with moderate to severe COVID-19 infection. Subsequently, we conducted a 1 year follow up study to investigate the occurrence of Post COVID conditions (PCC) in our study population through assessment of pulmonary function, symptoms, neurocognition and immune biomarkers to observe for any treatment group differences.

Key Dates

Start date
May 25, 2021
Status verified
Oct 2023
Primary completion
Apr 18, 2023
Completion
Apr 18, 2023

Study Design

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

Arms

  • Experimental: Dupilimab
    Dupilimab: 600 mg, given as two 300 mg subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28.
  • Placebo Comparator: Placebo
    Normal saline will be given as two one mL subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (1 mL) will be given on days 14 and 28.

Primary Outcome Measure

Day 28 Ventilator Free Survival [ Time Frame: at 28 Days ± 2d ]

Locations (1)

FacilityCityStateZIPSite coordinators
UVA HealthCharlottesvilleVirginia22908-

Find similar trials in Charlottesville, VA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
UVA Health· Charlottesville, VA

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