Status:
COMPLETED
Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
The Paul Manning Foundation
Virginia Catalyst
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 infecti...
Detailed Description
A total of 40 eligible subject were enrolled and randomized in a 1:1 ratio to receive either dupilumab or placebo, stratifying on the disease severity measured by the required oxygen ≤ 15L or \> 15L b...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older at the time of enrollment.
- Patients hospitalized with a positive RT-PCR for SARS-CoV-2 within the last 14 days, with illness duration within the last 14 days, and evidence of moderate to severe COVID-19 infection as defined by NIH COVID-19 Severity Categorization (8):
- Moderate illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen SpO2≥ 94% on room air at sea level.
- Severe illness: Individuals who have SpO2 \<94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mm Hg, respiratory frequency \>30 breaths/min, or lung infiltrates \>50%.
- Patient and/or legally authorized representative is willing and able to provide written informed consent and comply with all protocol requirements.
- Patients with hematologic malignancies or solid tumors are eligible.
- Patients with autoimmune disorders are eligible.
- Patients with immunodeficiency and organ or stem cell transplant recipients are eligible.
- Patients with acute or chronic renal injury/failure are eligible.
- Patients with neutropenia/lymphopenia are eligible.
- Patients with elevated liver function tests are eligible.
- Women who are not taking contraception are eligible.
- Patients who are currently or have recently received steroids and/or remdesivir are eligible.
- Patient agrees to not participate in another clinical trial for the treatment of COVID-19 through end of study period.
Exclusion
- Patients who do not require inpatient admission for COVID-19 infection.
- Patients who require invasive mechanical ventilation at time of enrollment.
- A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk due to study participation.
- Pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until two weeks after the last study product is given are not excluded).
- Allergy to Dupilumab or its excipients.
- Received any of the following in the two weeks prior to screening as treatment of COVID-19:
- small molecule tyrosine kinase inhibitors (e.g. imatinib, gefitinib, acalabrutinib, etc.);
- monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 \[IL-1\], anti-IL-6 \[or sarilumab\], etc.);
- monoclonal antibodies targeting T-cells or B-cells as treatment for COVID-19;
- Any other immunomodulatory (other than steroids) medications within 5 half-lives or 30 days prior to randomization.
- Current acute parasitic helminth infection or history of chronic parasitic infection.
- History of ocular scleritis, uveitis, keratitis or recent (\<6 months) eye injury (chemical or traumatic), infection or vascular occlusion.
- Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04920916
Start Date
May 25 2021
End Date
April 18 2023
Last Update
November 3 2023
Active Locations (1)
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1
UVA Health
Charlottesville, Virginia, United States, 22908