A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer

Inclusion Criteria

• Known diagnosis of active cancer that is not considered cured or disease free.
• Confirmed COVID-19 infection as per World Health Organization (WHO) criteria with suspected pneumonia requiring hospitalization and oxygen saturation < 94% on room air or requires supplemental oxygen.
• Adequate hematological, hepatic and renal function as would be medically expected of a cancer patient population.
• Able to swallow and absorb oral medications.

Exclusion Criteria

• Current active treatment with medications contraindicated for receipt of investigational product.
• Require chemotherapy or urgent systemic therapy for active cancer that cannot be withheld.
• No remaining available therapies for advanced or metastatic malignancies.
• Participation in another clinical study with therapeutic intent for COVID-19
• Require artificial ventilation at screening.
• Life expectancy less than 6 months.
• Medical conditions that make it unsafe to receive investigational product (for example, heart attack in the last 6 mos, unstable angina, uncontrolled arrhythmia, heart failure class 3/4, QTC interval > 480 msec; known bleeding disorders, stroke or intracranial hemorrhage in the last 6 mos; active HBV, HCV or history of HIV; GI malabsorption syndrome, small bowel resection, poorly controlled IBS; untreated/actively progressing known CNS lesions).
• Receipt of radiation therapy to the lung or mediastinum for treatment of COVID-19