Ignite Creation Date:
2024-05-06 @ 2:47 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04425252
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2020-06-09
Brief Title:
Safety and Anti-coronavirus Response of Suppression of Host Nucleotide Synthesis in Patients With COVID-19
Sponsor:
Clear Creek Bio Inc
Organization:
Clear Creek Bio Inc
Study Overview
Official Title:
The CRISIS Study A Randomized Open-label Study Assessing the Safety and Anti-coronavirus Response of Suppression of Host Nucleotide Synthesis in Hospitalized Adults With Coronavirus-19 COVID-19
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRISIS
Brief Summary:
This will be a phase 1a randomized open label multi-center study with approximately 24 subjects All subjects will receive standard of care SOC per institutional guidelines for treatment of hospitalized patients with COVID-19 infection In addition to SOC the brequinar group will receive 5 daily doses of brequinar 100 mg
Detailed Description:
This will be a phase 1a randomized open label multi-center study with approximately 24 subjects All subjects will receive standard of care SOC per institutional guidelines for SARS-CoV-2 infection Subjects will be randomly assigned in a 12 ratio to SOC alone or SOC plus brequinar The SOC plus brequinar group will receive 5 daily doses of brequinar 100 mg on Days 1 - 5 in addition to SOC Physical examinations vital signs laboratory assessments SARS-CoV-2 testing and other observations will be conducted by experienced personnel throughout the study based on the Schedule of Events Blood chemistry tests include blood urea nitrogen BUN creatinine alkaline phosphatase ALP alanine amino transferase ALT aspartate amino transferase AST bilirubin total protein albumin glucose serum electrolytes sodium potassium chloride carbon dioxidebicarbonate and calcium lactate dehydrogenase LDH Plasma will be collected for inflammatory markers such as D-dimer ferritin c-reactive protein CRP and erythrocyte sedimentation rate ESR Pro-inflammatory markers will be measured Serum is to be collected for research purposes Hematology tests include hemoglobin hematocrit complete blood count with full differential and platelet count Nasopharyngeal swabs for viral load will be collected Days 1 3 5 7 and 15 Survival will be assessed through Day 29
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None