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

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: QuantumLeap Healthcare Collaborative
• Collaborators: Columbia University; Emory University; Georgetown University; Hoag Memorial Hospital Presbyterian; Kalispell Regional Medical Center; Long Beach Memorial Medical Center; Main Line Health; Montefiore Medical Center; Northwestern University; Sanford Health; University of Alabama at Birmingham; University of California, Davis; University of California, San Diego; University of California, San Francisco; University of Colorado, Denver; University of Iowa; University of Minnesota; University of Pennsylvania; University of Southern California; Wake Forest University Health Sciences; Yale University
• Treatments: Apremilast; Celecoxib; Cyclosporine; Cyclosporins; Famotidine; Icatibant; Remdesivir; TAK-652

Criteria

Inclusion Criteria:

A. Male or Female, at least 18 years old.

B. Admitted to the hospital and placed on high flow oxygen (greater than 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 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.

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 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 120 hours (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.