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Monoclonal Antibodies

Dupilumab for COVID-19 (SafeDrop Trial)

Phase 2
Waitlist Available
Led By William A Petri Jr., MD, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 ± 90 days
Awards & highlights

SafeDrop Trial Summary

This trial is testing if a drug called dupilumab is effective and safe in treating patients with moderate to severe COVID-19 infection.

Eligible Conditions
  • COVID-19
  • Coronavirus

SafeDrop Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 ± 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 ± 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Day 28 Ventilator Free Survival
Follow up Study 1 Year Outcome: Pulmonary Function Testing- Oxygen Diffusion and 6 Minute Walk Testing
Secondary outcome measures
Change in C-reactive Protein (CRP)
Change in Ferritin
Change in Plasma Total Immunoglobulin E (IgE) Levels
+15 more
Other outcome measures
Change in National Institute of Allergy and Infectious Diseases 8-point ordinal scale
ICU length of stay (LOS)
Percentage of patients needing extracorporeal membrane oxygenation (ECMO)
+2 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

SafeDrop Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilimabExperimental Treatment1 Intervention
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 II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,994 Total Patients Enrolled
5 Trials studying COVID-19
10,117 Patients Enrolled for COVID-19
PBM C19 Research, LLC (a COVID-19 research entity of the Paul Manning Foundation)UNKNOWN
Virginia Catalyst, Virginia Biosciences Health Research Corporation (VBHRC)UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
[]Journal
Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients with Moderate to Severe COVID 19: A Phase Iia Trial
Sasson, Jennifer, Alexandra N. Donlan, Jennie Z. Ma, Heather M. Haughey, Rachael Coleman, Uma Nayak, Amy J. Mathers, et al.. 2022. “Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients with Moderate to Severe COVID 19: A Phase Iia Trial”. []. Cold Spring Harbor Laboratory. doi:10.1101/2022.03.30.22273194.
Open Forum Infectious DiseasesJournal
Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients with Moderate to Severe Coronavirus Disease 2019: A Phase 2a Trial
Sasson, Jennifer, Alexandra N Donlan, Jennie Z Ma, Heather M Haughey, Rachael Coleman, Uma Nayak, Amy J Mathers, et al.. 2022. “Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients with Moderate to Severe Coronavirus Disease 2019: A Phase 2a Trial”. Open Forum Infectious Diseases. Oxford University Press (OUP). doi:10.1093/ofid/ofac343.
[]Journal
Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients with Moderate to Severe COVID 19: A Phase Iia Trial
Sasson, Jennifer, Alexandra N. Donlan, Jennie Z. Ma, Heather M. Haughey, Rachael Coleman, Uma Nayak, Amy J. Mathers, et al.. 2022. “Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients with Moderate to Severe COVID 19: A Phase Iia Trial”. []. Cold Spring Harbor Laboratory. doi:10.1101/2022.03.30.22273194.
clinicaltrials.govStudy
Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients
William Petri, MD, PhD 2021. "Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04920916.
~10 spots leftby Apr 2025
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