Covid 19 Research Clinical Trials by Shray Alag

Zavegepant (BHV-3500)

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Correlated Drug Terms (2)

	Name (Synonyms)	Correlation
drug3594	Serology for Covid-19 Wiki	1.00
drug2916	Placebo Wiki	0.04

Correlated MeSH Terms (7)

	Name (Synonyms)	Correlation
D018410	Pneumonia, Bacterial NIH	1.00
D008173	Lung Diseases, Obstructive NIH	0.27
D008171	Lung Diseases, NIH	0.20

	Name (Synonyms)	Correlation
D011024	Pneumonia, Viral NIH	0.11
D011014	Pneumonia NIH	0.05
D045169	Severe Acute Respiratory Syndrome NIH	0.04
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (3)

	Name (Synonyms)	Correlation
HP:0006536	Pulmonary obstruction HPO	0.27
HP:0002088	Abnormal lung morphology HPO	0.20
HP:0002090	Pneumonia HPO	0.05

Clinical Trials

Navigate: Correlations HPO

There is one clinical trial.

1 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

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.

NCT04346615

Conditions

COVID-19 Infection

Interventions

Drug: Zavegepant (BHV-3500)
Drug: Placebo

Primary Outcomes

Description: a. Efficacy will be measured by the difference between groups in the meah 6-point severity rating at Day 15. The severity ratings are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: 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: Baseline to Day 15

Secondary Outcomes

Measure: 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: Baseline to Day 29

Measure: 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: Baseline to Day 29

Measure: Proportion of subjects admitted into an ICU on any day through Day 29 from AE eCRFs.

Time: Baseline to Day 29

Measure: 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: Baseline at Day 15 and at Day 29

Measure: 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: Baseline at Day 15 and at Day 29

Measure: Difference between treatment groups in the mean 6-point severity rating at Day 29

Time: Baseline to Day 29

Measure: Number of days from baseline to the first day through Day 29 with any 6-point severity rating greater than baseline.

Time: Baseline to Day 29

Measure: 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: Baseline to Day 29

Measure: Number of days from baseline to the first day through Day 29 with ≥ 1-point decrease in any NEWS2 score from baseline.

Time: Baseline to Day 29

Measure: Number of days from baseline to the first day through Day 29 with all NEWS2 scores < 2 on that day.

Time: Baseline to Day 29

Measure: Mean change from baseline in NEWS2 score at Days 15 and 29 for subjects who are alive at these time points

Time: Baseline at Day 15 and at Day 29.

Measure: 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: Baseline to Day 15

Measure: 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: Baseline to Day 60

Measure: 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: Baseline to Day 29

Measure: 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: Baseline to Day 29

Measure: 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: Baseline to Day 29

Measure: Mean number of ventilator-free days through Day 29 for subjects who are alive at Day 29.

Time: Baseline to Day 29

Measure: Mean SOFA total scores at ICU admission and Day 29 (if still in ICU), from SOFA and AE eCRFs.

Time: Baseline to Day 29

Measure: 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: Baseline to Day 29

Measure: 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: Baseline to Day 29

Measure: Number of subjects with deaths, SAEs, severe AEs, and Grade 3 or 4 laboratory test abnormalities at any time on study.

Time: Screening to Day 60

Measure: 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: Baseline to Day 29

Measure: Number and percentage of subjects with intranasal administration reactions at any time through Day 29 from AE/SAE eCRFs.

Time: Baseline to Day 29

Measure: Proportion of subjects with ≥ 50% reduction in eGFR from baseline at any time on study from laboratory test eCRFs.

Time: Baseline to Day 60

No related HPO nodes (Using clinical trials)

HPO

Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials

No related HPO nodes (Using clinical trials)

Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports MeSH Reports HPO Reports

CovidResearchTrials

Report Sections

See All Reports

Zavegepant (BHV-3500)

Correlations computed by analyzing all clinical trials.

Correlated Drug Terms (2)

Correlated MeSH Terms (7)

Correlated HPO Terms (3)

Clinical Trials

1 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

NCT04346615

Conditions

Interventions

Primary Outcomes

Secondary Outcomes

No related HPO nodes (Using clinical trials)

HPO

No related HPO nodes (Using clinical trials)

Reports

Interventions

MeSH

HPO

All Terms

Google Colab

Report Sections

See All Reports

Zavegepant (BHV-3500)

Correlations computed by analyzing all clinical trials.

Correlated Drug Terms (2)

Correlated MeSH Terms (7)

Correlated HPO Terms (3)

Clinical Trials

1 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 Click for details

NCT04346615

Conditions

Interventions

Primary Outcomes

Secondary Outcomes

No related HPO nodes (Using clinical trials)

HPO

No related HPO nodes (Using clinical trials)

Reports

Interventions

MeSH

HPO

All Terms

Google Colab

1 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