QuantumLeap Healthcare Collaborative
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.
COVID-19
Remdesivir
Imatinib Mesylate
Dexamethasone
Cenicriviroc
Icatibant
Apremilast
dornase alfa
Celecoxib
Famotidine
IC14
Aviptadil
narsoplimab
Cyproheptadine
Cyclosporine
PHASE2
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 this trial is a platform study for identifying effective agents for the treatment of COVID-19. Any critically ill patient with known or presumed COVID-19 will be automatically entered into the screening phase of the trial until SARS-CoV-2 infection is confirmed. Basic data will be assembled for each patient (such as ventilatory status and survival). If interested in the therapeutic portion of the trial, potential participants will be asked to sign a consent form describing the backbone treatment and the two specific investigational agent arms to which they may be randomized. The primary endpoints will be time to recover to a durable level 4 (or less) on the WHO COVID-19 ordinal scale for clinical improvement and time to mortality (death). For this trial, a durable level 4 is defined as at least 48 hours at COVID level 4 or less (nasal prongs oxygen) without returning to high flow oxygen or intubation. Acute care facility resource utilization will be automatically calculated (total length of stay in a critical care setting, days intubated, and survival). Any change in status, including intubation, extubation, death or discharge, will be recorded and verified by the attending physician. Patients will be evaluated based on their initial status (ventilation at entry vs. high flow oxygen). Exploratory biomarkers will be evaluated over time (ARDS phenotypes and other proposed markers) to facilitate clinical learning. A maximum of two investigational arms may be open at a time. The anticipated accrual will be 50 patients per week. The maximum number of participants assigned to an arm without graduation will be 125 patients. Agents can be dropped for futility after enrollment of 40 patients. As the trial proceeds and a better understanding of the underlying mechanisms of the COVID-19 illness emerges, expanded biomarker and data collection can be added as needed to further elucidate how agents are or are not working. The study design features comparison of investigational agent efficacy using a Bayesian design, which will allow the detection of strong efficacy signals with the fewest possible patients. Initially the control will be patients given current standard of care (supportive care for ARDS, including lung protective ventilation and remdesivir and dexamethasone as backbone therapy). As other treatments (for example, anticoagulation) become part of standard supportive care across sites, these will be added to the backbone therapy. If an agent meets the threshold for graduation the company leadership will be informed as will the FDA. The arm with the graduated agent will cease to enroll, allowing a new arm with a different investigational agent to be added. Every trial participant will have blood collected at trial enrollment, day 3, and day 7 for pre-specified biomarker and DNA and RNA analysis. Additional biomarkers can be added as the trial proceeds. Patient outcomes will also be evaluated on the basis of whether patients are ventilated initially or not. Observational Component: Initially, all COVID-19 confirmed patients who started high-flow oxygen (WHO COVID-19 level 5; ≥6L oxygen by nasal prongs or mask) were entered in an Observational Component which collected data via extraction of medical records. Patients in this Observational Component also had their daily COVID status and drug administration form CRFs completed. An expanded Observational Study will replace the original Observational Component. The expanded observational study (Supplement 1) will collect blood sample(s) and clinical data from ARDS and AHRF patients (including COVID ARDS patients) to test the feasibility of quantifying a set of biomarkers that will allow each patient to be classified into either a hyper-inflammatory or hypo-inflammatory subtype in real time. If treatment of these critically ill ICU patients is to be guided by subtype classification, it is essential that the operational time for classification is as quick as possible.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 1500 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients |
| Actual Study Start Date : | 2020-07-31 |
| Estimated Primary Completion Date : | 2028-07-31 |
| Estimated Study Completion Date : | 2030-07-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Alabama at Birmingham
Birmingham, Albama, United States, 35294
RECRUITING
UC Davis Medical Center
Davis, California, United States, 95817
RECRUITING
UC Irvine Medical Center
Irvine, California, United States, 92868
RECRUITING
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
RECRUITING
Kaiser LAMC
Los Angeles, California, United States, 90027
RECRUITING
University of Southern California
Los Angeles, California, United States, 90033
ACTIVE NOT RECRUITING
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
RECRUITING
University of California San Francisco (UCSF)
San Francisco, California, United States, 94115
RECRUITING
University of Colorado
Aurora, Colorado, United States, 80045
RECRUITING
Yale Cancer Center
New Haven, Connecticut, United States, 06510
ACTIVE NOT RECRUITING
Stamford Health
Stamford, Connecticut, United States, 06904
RECRUITING
Georgetown University
Washington, District of Columbia, United States, 20007
RECRUITING
University of Miami
Coral Gables, Florida, United States, 33124
ACTIVE NOT RECRUITING
University of Florida
Gainesville, Florida, United States, 32608
RECRUITING
Emory University
Atlanta, Georgia, United States, 30322
COMPLETED
Northwestern University
Chicago, Illinois, United States, 60611
COMPLETED
University of Iowa
Iowa City, Iowa, United States, 52242
ACTIVE NOT RECRUITING
University of Michigan
Ann Arbor, Road cancer, United States, 48109
RECRUITING
Corewell Health
Grand Rapids, Road cancer, United States, 49503
COMPLETED
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
COMPLETED
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
COMPLETED
Logan Health Medical Center
Kalispell, Montana, United States, 59901
RECRUITING
Virtua Mount Holly Hospital
Mount Holly, New Jersey, United States, 08060
RECRUITING
Virtua Voorhees Hospital
Voorhees, New Jersey, United States, 08043
COMPLETED
Montefiore Medical Center
Bronx, New York, United States, 10461
COMPLETED
Columbia University Medical Center
New York, New York, United States, 10032
COMPLETED
University of Rochester Medical Center
Rochester, New York, United States, 14642
RECRUITING
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
RECRUITING
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States, 44106
RECRUITING
University of Pennsylvania (U Penn)
Philadelphia, Pennsylvania, United States, 19104
RECRUITING
Lankenau Medical Center (Mainline Health)
White, Pennsylvania, United States, 19096
RECRUITING
Main Line Health - Lankenau Medical Center
White, Pennsylvania, United States, 19096
RECRUITING
Sanford Health
Sioux Falls, South Dakota, United States, 57109
RECRUITING
DHR Health
Edinburg, Texas, United States, 78539
ACTIVE NOT RECRUITING
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
ACTIVE NOT RECRUITING
WVU Medicine
Morgantown, West Virginia, United States, 26506