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

Study acronym: I-SPY_COVID
StatusActive, Not Recruiting
PhasePhase 2
Started2020-07-31
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 14 times since 2020-07-24; most recent filed 2026-03-12. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2026-03-12
Amendment Study Status, Sponsor/Collaborators v14
2026-03-11
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v13
2024-03-15
Amendment Study Status, Outcome Measures v12
2024-03-14
Amendment Study Status, Outcome Measures v11
2024-03-12
Amendment Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v10
2024-02-05
Amendment Study Status, Sponsor/Collaborators, Contacts/Locations v9
2023-10-17
Amendment Study Status, Sponsor/Collaborators, Contacts/Locations v8
2022-10-06
Amendment Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v7
2021-07-19
Amendment Study Status, Contacts/Locations v6
2021-06-18
Amendment Study Status, Sponsor/Collaborators, Arms and Interventions, Eligibility, Contacts/Locations v5
2021-03-31
Amendment Study Status, Arms and Interventions v4
2021-03-04
Amendment Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions v3
2020-09-25
Amendment Study Status, Contacts/Locations v2
2020-08-10
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2020-07-24
Original filing
Trial Details
NCT Number NCT04488081
Lead Sponsor QuantumLeap Healthcare Collaborative
Collaborators: University of California, San Francisco, Emory University, University of Alabama at Birmingham, University of Colorado, Denver, University of Southern California, Yale University, Wake Forest University Health Sciences, Long Beach Memorial Medical Center, Georgetown University, University of California, Davis, Main Line Health, DHR Health Institute for Research and Development, University of California, Irvine, University of Michigan, West Virginia University, University of Miami, University Hospitals Cleveland Medical Center, M.D. Anderson Cancer Center
Conditions COVID-19
Enrollment 1,500 participants
Start Date 2020-07-31
Primary Completion 2028-07-31 (estimated)
Study Completion 2030-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-16