Status:
WITHDRAWN
Ruxolitinib to Combat COVID-19
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Incyte Corporation
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators hypothesize that JAK 1/2 inhibition with ruxolitinib, an FDA approved treatment for intermediate or high-risk myelofibrosis, could have a similar effect in patients with severe COVID...
Eligibility Criteria
Inclusion
- A diagnosis of advanced COVID-19 as defined by both of the following:
- A positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (nasopharyngeal and oropharyngeal swab) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab
- Critical disease manifested by any of the following:
- Chest imaging (CT or chest X-ray permitted) with ≥ 50% lung involvement
- Respiratory failure requiring invasive mechanical ventilation or supplementary oxygen with FiO2 ≥ 50%
- Shock (defined as mean arterial pressure ≤ 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support
- Cardiac dysfunction defined by:
- New global systolic dysfunction with ejection fraction ≤ 40%
- Takotsubo cardiomyopathy
- New onset supraventricular or ventricular arrhythmias
- Plasma troponin I ≥ 0.10 ng/mL in someone without previously documented troponin elevation beyond that level
- Elevated plasma NT-proBNP in someone without documented prior elevation
- If Age \< 50, NT-proBNP \> 450 pg/ml
- If Age 50-74, NT-proBNP \> 900 pg/ml
- If Age ≥ 74, NT-proBNP \> 1800 pg/ml
- Receipt of investigational or off-label agents for COVID-19 (prior or ongoing) does not exclude eligibility.
- Patients who have received autologous or allogeneic stem cell transplant are eligible at the discretion of the investigators.
- 18 years of age or older at the time of study registration
- Adequate hematologic function defined as:
- absolute neutrophil count ≥ 1000/mm3
- platelet count ≥ 50,000/mm3 without growth factor or transfusion support for 7 days prior to screening
- Creatinine clearance ≥ 15 mL/minute or receiving renal replacement therapy
- Women of childbearing potential (defined as women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, or women who have had a tubal ligation) are required to have a negative pregnancy test and use two forms of acceptable contraception, including one barrier method, during participation in the study treatment period.
- Male patients (if engaging in reproductive sex with a women of childbearing potential) are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the evaluation period.
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
Exclusion
- Known allergy or intolerance to ruxolitinib or another JAK inhibitor.
- Known or suspected active viral (including HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
- Pregnant and/or breastfeeding.
- Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04354714
Start Date
June 30 2020
End Date
December 31 2021
Last Update
May 21 2020
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