I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (NCT04488081) | Clinical Trial Compass
Active — Not RecruitingPhase 2
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
United States1,500 participantsStarted 2020-07-31
Plain-language 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 will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 vasopresso…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.