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CGRP receptor antagonist

Zavegepant for Coronavirus Disease

Phase 2 & 3
Waitlist Available
Research Sponsored by Pfizer
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 baseline to day 60
Awards & highlights

Study Summary

This trial is testing a drug to see if it can help people with COVID-19 who are on oxygen. The drug is designed to help with the severe inflammatory response that can lead to difficulty breathing.

Eligible Conditions
  • Coronavirus Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To compare the efficacy of zavegepant (BHV-3500) to placebo in subjects hospitalized with COVID-19 infection requiring supplemental oxygen, using a six-point rating scale at Day 15. .
Secondary outcome measures
Number and percentage of subjects with intranasal administration reactions at any time through Day 29 from AE/SAE eCRFs.
Number and percentage of subjects with severe or life-threatening bacterial, invasive fungal, or opportunistic infections at any time through Day 29 from AE/SAE eCRFs.
Number of subjects with deaths, SAEs, severe AEs, and Grade 3 or 4 laboratory test abnormalities at any time on study.
+4 more

Side effects data

From 2021 Phase 2 & 3 trial • 974 Patients • NCT04408794
39%
Dysgeusia
10%
Nasal discomfort
7%
COVID-19
6%
Nausea
5%
Back pain
5%
Nasal congestion
5%
Throat irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zavegepant 10 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZavegepantExperimental Treatment1 Intervention
Zavegepant (BHV-3500) 10 mg intranasal (IN) dosed every 8 hours (3 times/day) (Q8h) for 14 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo Q8h for 14 days Subjects dosed every 8 hours; 3 times/day (Q8h)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zavegepant (BHV-3500)
2020
Completed Phase 3
~980

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,982 Total Patients Enrolled
Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
37,091 Total Patients Enrolled

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
clinicaltrials.govStudy
Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen
2020. "Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04346615.
~9 spots leftby Apr 2025
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