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

Trial ID or NCT#

NCT04488081

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
  2. A. Male or Female, at least 18 years old
  3. 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.
  4. C. Informed consent provided by the patient, LAR or health care proxy.
  5. D. Confirmation of SARS-CoV-2 infection by PCR or Rapid antigen testing for SARS- CoV-2 infection prior to randomization.
Exclusion Criteria:
  1. A. Pregnant or breastfeeding women (must be documented by a pregnancy test during hospitalization)
  2. 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.
  3. C. Comfort measures only.
  4. D. Acute liver disease, or chronic liver disease with a Child-Pugh score greater than 11.
  5. E. Resident for more than six months at a skilled nursing facility.
  6. F. Estimated mortality greater than 50% over the next six months from underlying chronic conditions.
  7. G. Time since requirement for high flow oxygen or ventilation greater than 5 days.
  8. H. Anticipated transfer to another hospital which is not a study site within 72 hours.
  9. I. Patients with either end-stage kidney disease or acute kidney injury who are on dialysis.
  10. J. Co-enrollment in clinical trials of pharmacologic agents requiring an IND.
  11. K. On 3 or more vasopressors.
  12. L. Pre-existing heart failure with a known left ventricular ejection fraction \<25% or unstable angina pectoris.
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Investigator(s)

Joseph Levitt, MD, MS
Joseph Levitt, MD, MS
Pulmonary critical care specialist, Pulmonologist, Critical care specialist
Associate Professor of Medicine (Pulmonary and Critical Care Medicine)

View on ClinicalTrials.gov