I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients

Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.

Inclusion Criteria:

• Male or Female, at least 18 years old.
• 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.
• Informed consent provided by the patient or health care proxy.
• Confirmation of SARS-CoV-2 infection by PCR prior to randomization.

Exclusion Criteria:

• Pregnant or breastfeeding women.
• 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.
• Comfort measures only.
• Acute or chronic liver disease with a Child-Pugh score greater than 11.
• Resident for more than six months at a skilled nursing facility.
• Estimated mortality greater than 50% over the next six months from underlying chronic conditions.
• Time since requirement for high flow oxygen or ventilation greater than 72 hours.
• Anticipated transfer to another hospital which is not a study site within 72 hours.