I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Running, not enrolling · Phase 2

Conditions studied: COVID-19

In brief

The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.

Key facts

Study ID

NCT04488081

Run by

QuantumLeap Healthcare Collaborative

People needed

1500

Starts

2020-07-31

Expected to finish

2030-07-31

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
• A. Male or Female, at least 18 years old
• B. Admitted to the hospital and placed on high flow oxygen (≥6L by nasal cannula or mask delivery system) or intubated for the treatment of (established or presumed) COVID-19.
• C. Informed consent provided by the patient, LAR or health care proxy.
• D. Confirmation of SARS-CoV-2 infection by PCR or Rapid antigen testing for SARS- CoV-2 infection prior to randomization.

You may not qualify if…

• A. Pregnant or breastfeeding women (must be documented by a pregnancy test during hospitalization)
• B. 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.
• C. Comfort measures only.
• D. Acute liver disease, or chronic liver disease with a Child-Pugh score greater than 11.
• E. Resident for more than six months at a skilled nursing facility.
• F. Estimated mortality greater than 50% over the next six months from underlying chronic conditions.
• G. Time since requirement for high flow oxygen or ventilation greater than 5 days.
• H. Anticipated transfer to another hospital which is not a study site within 72 hours.
• I. Patients with either end-stage kidney disease or acute kidney injury who are on dialysis.
• J. Co-enrollment in clinical trials of pharmacologic agents requiring an IND.
• K. On 3 or more vasopressors.
• L. Pre-existing heart failure with a known left ventricular ejection fraction <25% or unstable angina pectoris.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UC Davis Medical Center — Davis, California, United States
• UC Irvine Medical Center — Irvine, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Kaiser LAMC — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• University of California San Francisco (UCSF) — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Stamford Health — Stamford, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• University of Miami — Coral Gables, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Corewell Health — Grand Rapids, Michigan, United States
• Mercy Hospital Springfield — Springfield, Missouri, United States
• Kalispell Regional Medical Center — Kalispell, Montana, United States
• Logan Health Medical Center — Kalispell, Montana, United States
• Virtua Mount Holly Hospital — Mount Holly, New Jersey, United States
• Virtua Voorhees Hospital — Voorhees Township, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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