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I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
Sponsor: QuantumLeap Healthcare Collaborative
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.
Official title: I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2020-07-31
Completion Date
2030-07-31
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Remdesivir
Participants who receive remdesivir as part of their standard of care will be administered remdesivir by IV for up to ten days. Remdesivir 200mg loading dose on day 1, followed by 100mg IV once daily maintenance doses for 4 or 9 days.
Imatinib Mesylate
Subjects will be administered 800 mg on Day 1 orally, in divided doses of 400 mg administered twice per day. 400 mg daily will be administered orally for the following 9 days or until discharge, whichever is sooner.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Cenicriviroc
Oral, loading 300 mg qAM followed by 150 mg qPM, 12 hours apart on day 1, then 150 mg BID for total of 14 to 28 days depending on date of hospital discharge.
Icatibant
Subcutaneous, a safety run-in for the first 10 subjects was conducted using a regimen of 30 mg q8h × 3 days. All subsequent subjects received drug at 30 mg q8h x 6 days.
Apremilast
oral, 30 mg bid × 14 days.
dornase alfa
For Non-intubated subjects: 2.5 mg BID until hospital discharge, improvement to room air (or baseline oxygen use prior to illness) for 24 hours, or total of 14 days of study drug, whichever comes first. For intubated subjects: 5.0 mg BID in 10 mL normal saline until extubation or 14 days, whichever comes first. If intubated for less than 14 days, extubated subjects received 2.5 mg BID for a total Dornase treatment of 14 days, or until hospital discharge, whichever comes first.
Celecoxib
Oral: 400 mg BID for 7 days.
Famotidine
Oral: High dose 80 mg QID for 7 days followed by 40 mg BID for a course of 14 days.
IC14
intravenous, 4 mg/kg on day 1, followed by 2 mg/kg on days 2, 3, 4
Aviptadil
Inhalation via nebulizer, 100 µg three times (TID) daily for a maximum of 14 days
narsoplimab
Dosed at 4 mg/kg, given as a 30-minute intravenous infusion (up to a maximum of 370 mg per infusion) twice weekly for a total of four weeks (i.e. 9 doses) or until hospital discharge whichever comes first.
Cyproheptadine
4 mg tablet, with dosing regimen of 8 mg every 8 hours daily for ten (10) days. If the patient weighs less than 48 kg, the regimen is 6 mg every 8 hours daily for ten (10) days. If the participant was discharged before completion of this dosing regimen the drug was not continued.
Cyclosporine
Modified CsA at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.
Locations (36)
University of Alabama at Birmingham
Birmingham, Alabama, United States
UC Davis Medical Center
Davis, California, United States
UC Irvine Medical Center
Irvine, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Kaiser LAMC
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Stamford Health
Stamford, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Miami
Coral Gables, Florida, United States
University of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan
Ann Arbor, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Virtua Mount Holly Hospital
Mount Holly, New Jersey, United States
Virtua Voorhees Hospital
Voorhees Township, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States
University of Pennsylvania (U Penn)
Philadelphia, Pennsylvania, United States
Lankenau Medical Center (Mainline Health)
Wynnewood, Pennsylvania, United States
Main Line Health - Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Sanford Health
Souix Falls, South Dakota, United States
DHR Health
Edinburg, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
WVU Medicine
Morgantown, West Virginia, United States