CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Dupilumab +1 morebiological
Likely dose
Dupilumab 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04920916
NCT04920916Phase 2Completed
CompareCT.gov

Safety and Efficacy of the Treatment of Hospitalized Patients With COVID 19 Infection With an Inhibitor of IL-4 and IL-13 Signaling: A Phase IIa Trial

University of Virginia·interventional·Posted Jun 10, 2021·Updated Nov 3, 2023

In Brief

A Phase 2 clinical trial evaluating Dupilumab and Placebo for COVID-19. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
CollaboratorsThe Paul Manning Foundation, Virginia Catalyst

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 10, 2021
Enrollment StartMay 25, 2021
Primary CompletionApr 18, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.1 years ago

Interventions

Dupilumabbiological

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.

Placebodrug

Normal Saline.