Safety and Anti-coronavirus Response of Suppression of Host Nucleotide Synthesis in Patients With COVID-19 (CRISIS)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04425252|
Recruitment Status : Completed
First Posted : June 11, 2020
Results First Posted : February 16, 2022
Last Update Posted : February 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Brequinar Other: Standard of Care||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized 1:2 to standard of care (SOC) alone or SOC + brequinar|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||August 19, 2020|
|Actual Primary Completion Date :||December 29, 2020|
|Actual Study Completion Date :||January 12, 2021|
Standard of Care
Subjects are hospitalized for COVID-19 and will receive all supportive/interventional care per institutional guidelines.
Other: Standard of Care
Standard of Care per institutional guidelines for COVID-19 patients
Subjects will receive standard of care plus brequinar 100 mg daily (Study Days 1-5).
DHODH inhibitor, 100 mg daily x 5 days
Other Name: Standard of Care + Brequinar
- Safety/Tolerability Assessed by Rates of Grade 3 or 4 Post Randomization Adverse Events [ Time Frame: Through Day 15. ]Safety/tolerability as assessed by number of participants with Grade 3 or 4 post randomization adverse events.
- Safety/Tolerability as Assessed by Rates of Serious Adverse Events (SAEs). [ Time Frame: Through Day 15 ]Safety/tolerability as assessed by number of participants with Serious Adverse Events (SAEs).
- Safety/Tolerability Measured by Mortality at Day 29 [ Time Frame: Through Day 29 ]Safety/tolerability as measured by mortality at Day 29
- Hospitalization Status [ Time Frame: Days 3, 5, 7, and 15 ]All participants were hospitalized at time of study entry. This outcome measures participant hospitalization status at Days 3, 5, 7, and 15 in terms of: hospitalized in intensive care unit (ICU), hospitalized as part of initial admission, re-hospitalized (had been discharged from initial hospitalization and was re-admitted to the hospital) or was dead at the time of the assessment.
- Duration of Hospitalization [ Time Frame: Through Day 15 ]Duration in number of days from admission to discharge; days counted as an integer only.
- NEWS2 Score [ Time Frame: Baseline, Days 3, 5, 7, and 15. ]Measure Description: National Early Warning Score (NEWS) 2. Composite score of respiratory rate, oxygen saturation, systolic blood pressure, pulse, consciousness, and temperature. The NEWS2 provides a score of illness severity based on respiratory rate, SpO2, whether the patient is breathing room air or on oxygen, systolic blood pressure, heart rate, consciousness, and body temperature. The scale ranges from 20 (worst/sickest) to 0 (all measurements in a normal range). The NEWS2 was assessed at baseline, Days 3, 5, 7, and 15.
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): NCT04425252
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|United States, Florida|
|Baptist Medical Center|
|Jacksonville, Florida, United States, 32207|
|University of South Florida/Tampa General|
|Tampa, Florida, United States, 33606|
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|