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Trial record 1 of 1 for:    Vazegepant | COVID-19
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Safety and Efficacy Trial of Zavegepant* Intranasal for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346615
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief 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, 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.


Condition or disease Intervention/treatment Phase
COVID-19 Infection Drug: Zavegepant (BHV-3500) Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BHV3500-203: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of Zavegepant* (BHV-3500) Intranasal (IN) for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen
Actual Study Start Date : April 25, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Zavegepant
Zavegepant (BHV-3500) 10 mg intranasal (IN) Q8h for 14 days
Drug: Zavegepant (BHV-3500)
10 mg intranasal (IN) for 14 days

Placebo Comparator: Placebo
Placebo Q8h for 14 days
Drug: Placebo
Placebo Q8h for 14 days




Primary Outcome Measures :
  1. 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. . [ Time Frame: Baseline to Day 15 ]

    a. Efficacy will be measured by the difference between groups in the meah 6-point severity rating at Day 15. The severity ratings are:

    1. Death
    2. Hospitalized, on invasive mechanical ventilation or ECMO
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized


Secondary Outcome Measures :
  1. Proportion of subjects who have a 6-point severity rating of 5 or 6, are alive, and do not use supplemental oxygen as a procedure at Day 29. [ Time Frame: Baseline to Day 29 ]
  2. Proportion of subjects who have a 6-point severity rating of 2 or 3, or use any ventilation or high-flow nasal cannula as procedures, on any day through Day 29. [ Time Frame: Baseline to Day 29 ]
  3. Proportion of subjects admitted into an ICU on any day through Day 29 from AE eCRFs. [ Time Frame: Baseline to Day 29 ]
  4. Proportion of subjects who have a 6-point severity rating of 3, 4, 5, or 6, are alive, and do not use invasive mechanical ventilation as a procedure at Day 15. The analogous definition is applied to Day 29. [ Time Frame: Baseline at Day 15 and at Day 29 ]
  5. Proportion of subjects who have a 6-point severity rating of 4, 5 or 6, or use a low- or high-flow nasal, are alive, and do not use any ventilation at Day 15. The analogous definition is applied to Day 29. [ Time Frame: Baseline at Day 15 and at Day 29 ]
  6. Difference between treatment groups in the mean 6-point severity rating at Day 29 [ Time Frame: Baseline to Day 29 ]
  7. Number of days from baseline to the first day through Day 29 with any 6-point severity rating greater than baseline. [ Time Frame: Baseline to Day 29 ]
  8. Number of days from baseline to the first of any 2 consecutive days through Day 29 with all SpO2/FiO2 ratios > 400 on both days. [ Time Frame: Baseline to Day 29 ]
  9. Number of days from baseline to the first day through Day 29 with ≥ 1-point decrease in any NEWS2 score from baseline. [ Time Frame: Baseline to Day 29 ]
  10. Number of days from baseline to the first day through Day 29 with all NEWS2 scores < 2 on that day. [ Time Frame: Baseline to Day 29 ]
  11. Mean change from baseline in NEWS2 score at Days 15 and 29 for subjects who are alive at these time points [ Time Frame: Baseline at Day 15 and at Day 29. ]
  12. Proportion of subjects who have a 6-point severity rating of 5 or 6, are alive, and do not use supplemental oxygen as a procedure at Day 15. [ Time Frame: Baseline to Day 15 ]
  13. Proportion of subjects who are discharged from the hospital, have a 6-point severity rating of 6 on any day after discharge, and use supplemental oxygen on any day after discharge. [ Time Frame: Baseline to Day 60 ]
  14. Mean number of days with respiratory rate > 24 breaths/minute through Day 29 for subjects who are alive at Day 29 and do not use invasive mechanical ventilation. [ Time Frame: Baseline to Day 29 ]
  15. Mean number of days with supplemental oxygen use through Day 29 for subjects who are alive at Day 29. A day in which any 6-point severity rating is 2, 3, or 4, or supplemental oxygen is used as a procedure counts. [ Time Frame: Baseline to Day 29 ]
  16. Number of days from baseline to the first day through Day 29 on which any SpO2 ≥ 90%, any 6-point severity rating is 5 or 6, and no supplemental oxygen is used as a procedure. [ Time Frame: Baseline to Day 29 ]
  17. Mean number of ventilator-free days through Day 29 for subjects who are alive at Day 29. [ Time Frame: Baseline to Day 29 ]
  18. Mean SOFA total scores at ICU admission and Day 29 (if still in ICU), from SOFA and AE eCRFs. [ Time Frame: Baseline to Day 29 ]
  19. Mean number of days of hospitalization through Day 29 for subjects who are alive on Day 29. All days on study on or before hospitalization discharge are days of hospitalization, from 6-point severity rating scale eCRFs [ Time Frame: Baseline to Day 29 ]
  20. Number of days from baseline to the first of any 2 consecutive days through Day 29 in which all temperatures show lack of fever on both days and no antipyretics are used on either day. [ Time Frame: Baseline to Day 29 ]
  21. Number of subjects with deaths, SAEs, severe AEs, and Grade 3 or 4 laboratory test abnormalities at any time on study. [ Time Frame: Screening to Day 60 ]
  22. 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. [ Time Frame: Baseline to Day 29 ]
  23. Number and percentage of subjects with intranasal administration reactions at any time through Day 29 from AE/SAE eCRFs. [ Time Frame: Baseline to Day 29 ]
  24. Proportion of subjects with ≥ 50% reduction in eGFR from baseline at any time on study from laboratory test eCRFs. [ Time Frame: Baseline to Day 60 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must provide informed consent in accordance with requirements of the study center's institutional review board (IRB) or eithics committee prior to the initiation of any protocol-required procedures
  2. Subjects must agree to provide all requested demographic information (i.e. gender, race)
  3. Subjects must be able to read and understand English or Spanish
  4. Subjects must be over the age of 18 years
  5. Subjects must have laboratory-confirmed SARS-CoV-2 infection as determined by PCR-based commercial or public health assay
  6. Subjects must have symptoms that require hospitalization with supplemental oxygen and / or non-invasive ventilation as determined by the admitting physician. The maximum nasal cannula O2 concentration should be determined by the treating clinician and the limitations of the specific equipment
  7. Subjects must be willing and able to comply with study-related procedures/assessments

Exclusion Criteria:

  1. Subjects in immediate need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
  2. Subjects with an eGFR < 30 mL/min, at the Screening Visit
  3. Prisoners or subjects who are involuntarily incarcerated
  4. Subjects who are participating in any other investigational clinical trial while participating in this clinical trial
  5. Subjects who are under the age of 18 years
  6. Subjects who are pregnant (all potential female enrollees need to have a negative pregnancy test prior to IP administration)
  7. Subjects with multi-organ failure
  8. Subjects who have received more than 48 hours of supplemental oxygen prior to randomization
  9. Subjects with prior significant pulmonary disease (e.g., severe COPD/ILD/CHF/IPF) are excluded
  10. Subjects receiving investigational therapies as part of a formal clinical trial for the treatment of COVID-19. During the course of this study, investigational therapies that may become "standard of care" to treat COVID-19, but are not part of a clinical trial, are allowed
  11. Subjects who are on long-acting CGRP monoclonal antibodies will be excluded including Aimovig (erenumab), Emgality (galcanezumab), Ajovy (fremanezumab), and Vyepti (eptinezumab). Additionally, the investigational oral CGRP receptor antagonist, atogepant, that is taken daily will also be excluded. Oral CGRP receptor antagonists, Nurtec ODT (rimegepant) and Ubelvy (ubrogepant) that are typically used PRN infrequently will not be excluded as long the subject was not taking them on a daily basis and does not take them during the current study
  12. Subjects who are unlikely to survive for more than 48 hours from the Screening Visit
  13. Subjects with any of the following abnormal laboratory values at screening: aspartate AST or ALT greater than 5x ULN or bilirubin greater than 2x ULN
  14. Subjects with known active TB, history of incompletely treated TB, suspected or known extrapulmonary TB
  15. Subjects with suspected or known systemic bacterial or fungal infections. However, empiric antibiotics are permitted.
  16. Subjects who have participated in any clinical research study evaluating an IP or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit
  17. Subjects with any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346615


Contacts
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Contact: Elyse Stock, MD 203-404-0410 clinicaltrials@biohavenpharma.com

Locations
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United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Maximiliano Menna    202-444-0371    Mpm229@georgetown.edu   
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Agbenu Amali    215-503-8954    Agbenu.Amali@Jefferson.edu   
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04346615    
Other Study ID Numbers: BHV3500-203
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biohaven Pharmaceuticals, Inc.:
COVID-19
COVID
Coronavirus
Biohaven
Intranasal
SARS-CoV-2
BHV-3500
Zavegepant