Source: https://tulane.trialstoday.org/trial/NCT04419623
Timestamp: 2020-08-13 20:39:29
Document Index: 57982435

Matched Legal Cases: ['art 1', 'art 2', 'art 2', 'art 2', 'art 1', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2']

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.
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, except where patients are receiving hydroxychloroquine or chloroquine and/or azithromycin and/or remdesivir.
Require artificial ventilation at screening.
Advanced healthcare directive that includes do not intubate (DNI) or do not resuscitate (DNR) orders
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
In Part 1, up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose. In Part 2, 64 subjects will be randomized to the recommended TL-895 dose w/ SAT (Arm 1), and 64 subjects will be randomized to Placebo w/ SAT (Arm 2).
The control product in this study is placebo. The placebo will only be used in Part 2. Placebo will be matched in appearance and packaging to active investigational product TL-895. Investigators and Sponsor will be blinded to each subject's assigned study treatment in Part 2 (the double-blind, placebo-controlled portion of the study) via unique kit numbers on study drug cartons.
Part 1 - Dose Finding TL-895 orally BID at up to 3 dose levels taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).
Drug: Part 1 - TL-895
TL-895, administered by mouth
Part 2 - Arm 1 - TL-895 at recommended dose TL-895 orally BID at the recommended dose continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).
Drug: Part 2 - TL-895
Part 2 - Arm 2 - Placebo at recommended dose Placebo orally BID at the recommended dose continuously in 7-day cycles for 2 - 4 cycles with standard available treatment for COVID-19 (14 - 28 days of treatment).
Drug: Part 2 - Placebo
Matching Placebo (dummy pill), administered by mouth
Telios Pharma, Inc.
650-542-0136
jmei@teliospharma.com
This study (NCT04419623) was last processed and updated on 7/21/2020 by ClinicalTrials.gov.