Duvelisib to Combat COVID-19

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Apr 30, 2020

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Eligibility criteria

• Inclusion Criteria:
• * A diagnosis of advanced COVID-19 as defined both of the following:
• • as a positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (e.g. nasopharyngeal, nasal, oropharyngeal swab, or saliva) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab with an FDA approved assay.
• * Critical disease manifested by any of the following:
• • Chest imaging with ≥ 50% lung involvement
• • Respiratory failure requiring invasive mechanical ventilation, non-invasive mechanical ventilation (eg. BiPAPA, OptiFlow), supplementary oxygen with FiO2 ≥ 6 LPM or extracorporeal membrane oxygenation (ECMO)
• • 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
• • Patients who have received prior investigational or off-label agents for COVID-19 does not exclude eligibility.
• • At least 18 years of age at the time of study registration
• • Adequate hematologic function defined as absolute neutrophil count ≥1000/mm3 and 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
• • Aminotransferase (AST/ALT) levels \<3x the upper limit of normal
• • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
• • 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 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.
• Exclusion Criteria:
• • Known allergy or intolerance to duvelisib or another PI3K inhibitor.
• • Known or suspected active viral (including CMV, HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. CMV viral load will be assessed at screening and those with viremia will be excluded. Other 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.