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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborators: PBM C19 Research, LLC (a COVID-19 research entity of the Paul Manning Foundation); PBM C19 Research, LLC (PBM); Virginia Catalyst, Virginia Biosciences Health Research Corporation (VBHRC)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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. baricitinib, imatinib, gefitinib, acalabrutinib, etc.);

• monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab 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.