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

Launched by QUANTUMLEAP HEALTHCARE COLLABORATIVE · Jul 24, 2020

Keywords

ClinConnect Summary

The I-SPY COVID-19 Trial is a research study designed to find new treatments for critically ill patients who have COVID-19. This trial aims to quickly test different promising medications to see if they can help reduce the chances of dying from the disease and lessen the time patients need to be on machines that help them breathe.

To participate in this trial, patients must be at least 18 years old and currently hospitalized, needing high-flow oxygen or have been intubated due to COVID-19. They must also have a confirmed COVID-19 infection. However, certain individuals, like pregnant women or those with severe underlying health conditions, cannot join. If eligible, participants can expect to receive one of the new treatment options and will be closely monitored throughout the study. This trial is currently recruiting participants, and it focuses on finding effective treatments to improve outcomes for those severely affected by COVID-19.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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.
• Exclusion Criteria:
• • 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.