Co-enrollment in clinical trials of pharmacologic agents requiring an IND Patients with either end-stage kidney disease or acute kidney injury who are on dialysis. Anticipated transfer to another hospital which is not a study site within 72 hours. Time since requirement for high flow oxygen or ventilation greater than 5 days. Estimated mortality greater than 50% over the next six months from underlying chronic conditions. Resident for more than six months at a skilled nursing facility.į. Acute liver disease, or chronic liver disease with a Child-Pugh score greater than 11.Į. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history.ĭ. Pregnant or breastfeeding women (must be documented by a pregnancy test during hospitalization)ī. Confirmation of SARS-CoV-2 infection by PCR or Rapid antigen testing for SARS-CoV-2 infection prior to randomization.Ī. Informed consent provided by the patient or health care proxy.ĭ. Admitted to the hospital and placed on high flow oxygen (greater than 6L by nasal cannula or mask delivery system) or intubated for the treatment of (established or presumed) COVID-19.Ĭ. All COVID-19 confirmed patients who start high-flow oxygen (WHO COVID-19 level 5 ≥6L oxygen by nasal prongs or mask) will be entered in an Observational Component which will collect data via extraction of medical records.Ī. Patient outcomes will also be evaluated on the basis of whether patients are ventilated initially or not. Additional biomarkers can be added as the trial proceeds. Information about agents disposition will be as follows:Įvery trial participant will have blood collected at trial enrollment, day 3, and day 7 for pre-specified biomarker and DNA and RNA analysis. The arm with the graduated agent will cease to enroll, allowing a new arm with a different investigational agent to be added. If an agent meets the threshold for graduation the company leadership will be informed as will the FDA. As other treatments (for example, anticoagulation) become part of standard supportive care across sites, these will be added to the backbone therapy. Initially the control will be patients given current standard of care (supportive care for ARDS, including lung protective ventilation and remdesivir and dexamethasone as backbone therapy). The study design features comparison of investigational agent efficacy using a Bayesian design, which will allow the detection of strong efficacy signals with the fewest possible patients. As the trial proceeds and a better understanding of the underlying mechanisms of the COVID-19 illness emerges, expanded biomarker and data collection can be added as needed to further elucidate how agents are or are not working. Agents can be dropped for futility after enrollment of 40 patients. The maximum number of participants assigned to an arm without graduation will be 125 patients. The anticipated accrual will be 50 patients per week. A maximum of two investigational arms may be open at a time. Exploratory biomarkers will be evaluated over time (ARDS phenotypes and other proposed markers) to facilitate clinical learning. Patients will be evaluated based on their initial status (ventilation at entry vs. Any change in status, including intubation, extubation, death or discharge, will be recorded and verified by the attending physician. Acute care facility resource utilization will be automatically calculated (total length of stay in a critical care setting, days intubated, and survival). For this trial, a durable level 4 is defined as at least 48 hours at COVID level 4 or less (nasal prongs oxygen) without returning to high flow oxygen or intubation. The primary endpoints will be time to recover to a durable level 4 (or less) on the WHO COVID-19 ordinal scale for clinical improvement and time to mortality (death). If interested in the therapeutic portion of the trial, potential participants will be asked to sign a consent form describing the backbone treatment and the two specific investigational agent arms to which they may be randomized. Basic data will be assembled for each patient (such as ventilatory status and survival). Any critically ill patient with known or presumed COVID-19 will be automatically entered into the screening phase of the trial until SARS-CoV-2 infection is confirmed. The main focus of this trial is a platform study for identifying effective agents for the treatment of COVID-19. This platform trial will provide access to repurposed and investigational agents for critically ill patients infected with SARS-CoV-2 who have severe or life-threatening COVID-19.
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