Phase 2
Completed N=115
CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19
COVID-19 Infection
Source: ClinicalTrials.gov NCT04575038 ↗
Enrolled (actual)
115
Serious AEs
0.9%
Results posted
Apr 2022
Primary outcomePrimary: Log10 SARS-CoV-2 Viral Load — 5.056; 5.110; -1.651; -1.881 Log 10 SARS-CoV-2 Viral Load Copies/mL
Summary
This study will assess the efficacy and safety of DHODHi (brequinar) as an antiviral via 5 days of treatment of participants with positive COVID-19 and at least one symptom of COVI019 in an out-patient setting. The study is multi-center, randomized, and placebo-controlled.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log10 SARS-CoV-2 Viral Load |
5.056; 5.110; -1.651; -1.881; -2.413; -3.231 | — |
| SECONDARY Rates of AEs and SAEs Including Laboratory Assessments |
10; 13; 8; 8; 1; 2 | — |
| SECONDARY Viral Shedding Duration |
12.0; 8.0 | — |
| SECONDARY Hospital Admission |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent for the trial, written, electronic, verbal or other method deemed acceptable by the institution and IRB.
- 18 years of age or older.
- Laboratory-confirmed SARS-CoV-2 infection as determined by real time polymerase chain reaction (RT-PCR) or other FDA-approved commercial or public health assay.
- Out-patient (never hospitalized as an in-patient for COVID-19 or was evaluated/treated for COVID-19 only in the Emergency Room with a stay of 2 x ULN, or total bilirubin > ULN. Gilbert's Syndrome is allowed.
- Bleeding disorders or blood loss requiring transfusion in the six weeks preceding enrollment
- Ongoing gastrointestinal ulcer, or gastrointestinal bleeding within 6 weeks of randomization.
- Chronic hepatitis B infection, active hepatitis C infection, active liver disease and/or cirrhosis per subject report.
- Heart failure, current uncontrolled cardiovascular disease, including unstable angina, uncontrolled arrhythmias, major adverse cardiac event within 6 months (e.g. stroke, myocardial infarction, hospitalization due to heart failure, or revascularization procedure).
Data sourced from ClinicalTrials.gov (NCT04575038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.