Phase COVID-II
I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients
- Study HIC#:2000028816
- Last Updated:01/30/2024
Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.
- Age18 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Jackie Prinz
- Phone Number: 1-203-785-5977
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.
Eligibility Criteria
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.