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Adaptive platform trial for critically ill COVID-19 patients

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

Phase 2 Interventional QuantumLeap Healthcare Collaborative · NCT04488081

This study is testing different treatments for critically ill COVID-19 patients in the hospital to see which ones can help them recover faster and reduce the need for breathing support.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment1500 (estimated)
Ages18 Years and up
SexAll
SponsorQuantumLeap Healthcare Collaborative Academic / other
Locations36 sites (Birmingham, Alabama and 35 other locations)
Trial IDNCT04488081 on ClinicalTrials.gov

What this trial studies

This trial aims to rapidly evaluate promising treatments for critically ill patients suffering from severe COVID-19. It employs an adaptive platform design to screen various investigational agents, including remdesivir and dexamethasone, to determine their effectiveness in reducing mortality and the need for mechanical ventilation. Patients who are admitted to the hospital and require high flow oxygen or intubation will be enrolled, and their clinical outcomes will be closely monitored. The trial will assess recovery times and resource utilization in acute care settings.

Who should consider this trial

Good fit: Ideal candidates for this trial are adults aged 18 and older who are hospitalized with severe or life-threatening COVID-19 and require high flow oxygen or intubation.

Not a fit: Patients who are pregnant, breastfeeding, or have severe underlying health conditions may not benefit from this trial.

Why it matters

Potential benefit: If successful, this trial could lead to effective treatments that significantly improve survival rates and recovery times for critically ill COVID-19 patients.

How similar studies have performed: Other studies utilizing adaptive platform designs for COVID-19 treatments have shown promise, indicating that this approach could yield valuable insights.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions COVID-19severe diseasePlatform TrialAcute Respiratory Distress SyndromeARDSSARS-COV-2AHRFAcute Hypoxemic Respiratory Failure
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.