0 0.25 0.5 0.75 1 1.25 1.5 1.75 2+ BHV-3500 Amali (DB RCT) -168% 2.68 [0.34-20.9] death 5/28 1/15 Improvement, RR [CI] Treatment Control Tau​2​ = 0.00, I​2​ = 0.0%, p = 0.35 Late treatment -168% 2.68 [0.34-20.9] 5/28 1/15 168% higher risk All studies -168% 2.68 [0.34-20.9] 5/28 1/15 168% higher risk 1 zavegepant COVID-19 study c19early.org November 2025 Tau​2​ = 0.00, I​2​ = 0.0%, p = 0.35 Effect extraction pre-specified(most serious outcome) Favors zavegepant Favors control
Zavegepant is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist.
May 2
2024
 Amali et al., NCT04346615 BHV3500-203: Phase 2/3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of Zavegepant (BHV-3500) Intranasal (IN) for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen
168% higher mortality (p=0.4), 25% higher ICU admission (p=1), and 11% worse recovery (p=0.47). RCT 47 hospitalized COVID-19 patients in the USA showing no significant differences with zavegepant treatment.