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NCT04346615 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Pfizer.

Terminated
Registry status
Phase 2
Development phase
47
Enrollment target

NCT04346615 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 47 participants.

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The verdict

NCT04346615, a Phase 2 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 2
Development phase
47 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Zavegepant (BHV-3500)

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2020-04-25
Est. Completion 2022-04-29
Phase Phase 2

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT04346615

The ClinicalTrials.gov registry entry for NCT04346615 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04346615 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04346615 about?

NCT04346615 is a clinical study titled "Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen". 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, arti...

What is the current status of trial NCT04346615?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2020-04-25. Estimated completion is 2022-04-29.

What interventions are being tested in trial NCT04346615?

The interventions under investigation include: Placebo (DRUG), Zavegepant (BHV-3500) (DRUG).

Who is sponsoring clinical trial NCT04346615?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.