Status:
RECRUITING
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
Lead Sponsor:
QuantumLeap Healthcare Collaborative
Collaborating Sponsors:
University of California, San Francisco
University of Pennsylvania
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This platform trial will provide access to repurposed and investigational agents for critically ill patients infected with SARS-CoV-2 who have severe or life-threatening COVID-19. The main focus of th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04488081
Start Date
July 31 2020
End Date
July 31 2030
Last Update
March 19 2024
Active Locations (36)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
UC Davis Medical Center
Davis, California, United States, 95817
3
UC Irvine Medical Center
Irvine, California, United States, 92868
4
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806