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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2023-04-18

Brief Summary

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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.

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Detailed Description

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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 by nasal cannula. Both arms received standard of care management per current National Institutes of Health (NIH) COVID-19 treatment guideline in addition to their randomized treatments. Patients were then followed prospectively for up to 360 days after enrollment.

As an extension to the randomized double-blind placebo-controlled trial assessing dupilumab for treatment of those hospitalized with acute moderate to severe COVID-19, subjects were followed up at 1 year for evaluation of pulmonary function testing (PFT), pulmonary imaging, immune biomarkers, neurocognition and symptoms.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Dupilumab

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal Saline.

Interventions

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Dupilumab

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.

Intervention Type BIOLOGICAL

Placebo

Normal Saline.

Intervention Type DRUG

Other Intervention Names

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Dupixent

Eligibility Criteria

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Inclusion Criteria

* 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 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. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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William Petri, MD, PhD

Wade Hampton Frost Professor of Medicine and Vice Chair for Research of the Department of Medicine, and Professor of Medicine, Microbiology, Immunology and Cancer Biology, and Pathology, Medicine: Infectious Diseases and International Health

Responsibility Role PRINCIPAL_INVESTIGATOR