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Neurokinin-1 Receptor Antagonist

Tradipitant for Coronavirus

Phase 3
Waitlist Available
Research Sponsored by Vanda Pharmaceuticals
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 14 days or discharge
Awards & highlights

Study Summary

This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection. On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days or discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days or discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to improvement on a 7-point ordinal scale as compared to baseline
Secondary outcome measures
In-hospital mortality
Mean change in NEWS2 score from baseline
Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples
+6 more

Side effects data

From 2021 Phase 1 & 2 trial • 27 Patients • NCT04849559
15%
fatigue
15%
somnolence
8%
peripheral swelling
8%
diarrhea
8%
Acne
8%
disturbance in attention
8%
dizziness postural
8%
restless leg syndrome
8%
depressed mood
8%
libido decreased
8%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tradipitant
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TradipitantExperimental Treatment1 Intervention
Tradipitant 85 mg PO BID
Group II: PlaceboPlacebo Group1 Intervention
2 capsules of matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tradipitant
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
61 Previous Clinical Trials
19,104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~60 spots leftby Apr 2025