drugset / Trial / NCT04346615

Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen

NCT04346615

Phase 2/3 Terminated 47 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if a CGRP receptor antagonist may potentially blunt the severe inflammatory response at the alveolar level, delaying or reversing the path towards oxygen desaturation, Acute respiratory distress syndrome (ARDS), requirement for supplemental oxygenation, artificial ventilation or death in patients with COVID-19 on supplemental oxygen. \* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.

Timeline

Start
2020-04-25
Primary completion
2022-04-29
Completion
2022-04-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Zavegepant Small molecule 10 mg Intranasal

Indications