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

Who is this study for? Adult patients with COVID-19 Infection
What treatments are being studied? Remdesivir
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
UC Davis Medical Center
RECRUITING
Davis
UC Irvine Medical Center
RECRUITING
Irvine
Long Beach Memorial Medical Center
RECRUITING
Long Beach
Kaiser LAMC
RECRUITING
Los Angeles
University of Southern California
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
ACTIVE_NOT_RECRUITING
Newport Beach
University of California San Francisco (UCSF)
RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Stamford Health
ACTIVE_NOT_RECRUITING
Stamford
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Florida
University of Miami
RECRUITING
Coral Gables
University of Florida
ACTIVE_NOT_RECRUITING
Gainesville
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa
COMPLETED
Iowa City
Illinois
Northwestern University
COMPLETED
Chicago
Michigan
University of Michigan
ACTIVE_NOT_RECRUITING
Ann Arbor
Corewell Health
RECRUITING
Grand Rapids
Missouri
Mercy Hospital Springfield
COMPLETED
Springfield
Montana
Kalispell Regional Medical Center
COMPLETED
Kalispell
Logan Health Medical Center
COMPLETED
Kalispell
North Carolina
Wake Forest Baptist Comprehensive Cancer Center
RECRUITING
Winston-salem
New Jersey
Virtua Mount Holly Hospital
RECRUITING
Mount Holly
Virtua Voorhees Hospital
RECRUITING
Voorhees Township
New York
Columbia University Medical Center
COMPLETED
New York
University of Rochester Medical Center
COMPLETED
Rochester
Montefiore Medical Center
COMPLETED
The Bronx
Ohio
University Hospital Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania (U Penn)
RECRUITING
Philadelphia
Lankenau Medical Center (Mainline Health)
RECRUITING
Wynnewood
Main Line Health - Lankenau Medical Center
RECRUITING
Wynnewood
South Dakota
Sanford Health
RECRUITING
Sioux Falls
Texas
DHR Health
RECRUITING
Edinburg
University of Texas MD Anderson Cancer Center
ACTIVE_NOT_RECRUITING
Houston
West Virginia
WVU Medicine
ACTIVE_NOT_RECRUITING
Morgantown
Contact Information
Primary
Paul Henderson, PhD
p.henderson@quantumleaphealth.org
1-925-570-1615
Backup
Karyn DiGiorgio, MS
karyn.digiorgio@quantumleaphealth.org
1-415-307-1539
Time Frame
Start Date: 2020-07-31
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 1500
Treatments
Active_comparator: Control/Backbone - Remdesivir and Dexamethasone (CLOSED)
Participants randomized to the backbone control will be given standard of care (supportive care for ARDS, including remdesivir and, if needed, lung protective ventilation). Because dexamethasone was shown to have benefit in at least one large randomized clinical trial, patients in the backbone control arm should receive dexamethasone for a total of 10 days during the hospitalization or until or hospital discharge.~Remdesivir (intravenous): 200-mg loading dose on day 1, followed by a daily maintenance dose of 100-mg on days 2 through 10.~Dexamethasone (intravenous): 6 mg intravenous or oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Experimental: Imatinib + Standard of Care (CLOSED)
Subjects will be administered standard of care + 800 mg imatinib 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.
Experimental: Cenicriviroc + Standard of Care (CLOSED)
Subjects administered standard of care + cenicriviroc orally , 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.
Experimental: Icatibant + Standard of Care (CLOSED)
Subjects administered standard of care + icatibant subcutaneously, 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.
Experimental: Apremilast + Standard of Care (CLOSED)
Subjects administered standard of care + apremilast orally , 30 mg bid × 14 days.
Experimental: Dornase + Standard of Care (CLOSED)
For Non-intubated subjects: Subjects administered standard of care + dornase, 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: Subjects administered standard of care + dornase, 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.
Experimental: Celecoxib/famotidine + Standard of Care (CLOSED)
Subjects administered standard of care + celecoxib/famotidine orally .~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.
Experimental: IC14 + Standard of Care (CLOSED)
Subjects administered standard of care + IC14 intravenously , 4 mg/kg on day 1, followed by 2 mg/kg on days 2, 3, 4
Experimental: Narsoplimab + Standard of Care (CLOSED)
Subjects administered standard of care + 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.
Experimental: Aviptadil + Standard of Care (CLOSED)
Subjects administered standard of care + aviptadil (inhalation via nebulizer), 100 µg three times (TID) daily for a maximum of 14 days
Experimental: Cyproheptadine + Standard of Care (CLOSED)
Subjects administered standard of care + cyproheptadine via 4 mg tablet, with dosing regimen of 8 mg every 8 hours daily for ten (10) days.
Experimental: Cyclosporine + Standard of Care (CLOSED)
Subjects administered standard of care + modified cyclosporine at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.
Experimental: Imatinib (PENDING ACTIVATION)
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.
Sponsors
Collaborators: University of Southern California, Emory University, University of Miami, DHR Health Institute for Research and Development, University of Michigan, University of California, Irvine, Virtua Health, Georgetown University, Corewell Health, University Hospitals Cleveland Medical Center, M.D. Anderson Cancer Center, Kaiser Permanente, University of Pennsylvania, Long Beach Memorial Medical Center, Hoag Memorial Hospital Presbyterian, Yale University, Wake Forest University Health Sciences, Main Line Health, Sanford Health, University of Alabama at Birmingham, University of California, Davis, University of Colorado, Denver, University of California, San Francisco, West Virginia University
Leads: QuantumLeap Healthcare Collaborative

This content was sourced from clinicaltrials.gov