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

NCT04920916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-03

Study results available
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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. 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.

Conditions

Interventions

BIOLOGICAL

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.

DRUG

Placebo

Normal Saline.

Sponsors & Collaborators

  • The Paul Manning Foundation

    collaborator OTHER

  • Virginia Catalyst

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • William A Petri Jr., MD, PhD · University of Virginia Division of Infectious Disease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2023-04-18
Completion
2023-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04920916 on ClinicalTrials.gov