RECRUITING

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

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Conditions

COVID-19severe diseasePlatform TrialAcute Respiratory Distress SyndromeARDSSARS-COV-2AHRFAcute Hypoxemic Respiratory Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-07-31
Study Completion:2030-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04488081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Paul Henderson, PhD
CONTACT
1-925-570-1615
p.henderson@quantumleaphealth.org
Karyn DiGiorgio, MS
CONTACT
1-415-307-1539
karyn.digiorgio@quantumleaphealth.org

Principal Investigator

Carolyn Carolyn, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Kathleen D Liu, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Laura Esserman, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
UC Davis Medical Center
Davis, California, 95817
United States
UC Irvine Medical Center
Irvine, California, 92868
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
Kaiser LAMC
Los Angeles, California, 90027
United States
University of Southern California
Los Angeles, California, 90033
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
University of California San Francisco (UCSF)
San Francisco, California, 94115
United States
University of Colorado
Aurora, Colorado, 80045
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Stamford Health
Stamford, Connecticut, 06904
United States
Georgetown University
Washington, District of Columbia, 20007
United States
University of Miami
Coral Gables, Florida, 33124
United States
University of Florida
Gainesville, Florida, 32608
United States
Emory University
Atlanta, Georgia, 30322
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901
United States
Logan Health Medical Center
Kalispell, Montana, 59901
United States
Virtua Mount Holly Hospital
Mount Holly, New Jersey, 08060
United States
Virtua Voorhees Hospital
Voorhees, New Jersey, 08043
United States
Montefiore Medical Center
Bronx, New York, 10461
United States
Columbia University Medical Center
New York, New York, 10032
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44106
United States
University of Pennsylvania (U Penn)
Philadelphia, Pennsylvania, 19104
United States
Lankenau Medical Center (Mainline Health)
Wynnewood, Pennsylvania, 19096
United States
Main Line Health - Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
Sanford Health
Sioux Falls, South Dakota, 57109
United States
DHR Health
Edinburg, Texas, 78539
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
WVU Medicine
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: QuantumLeap Healthcare Collaborative

  • Carolyn Carolyn, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Kathleen D Liu, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Laura Esserman, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-31
Study Completion Date2030-07-31

Study Record Updates

Study Start Date2020-07-31
Study Completion Date2030-07-31

Terms related to this study

Keywords Provided by Researchers

  • COVID-19
  • severe disease
  • Platform Trial
  • Acute Respiratory Distress Syndrome
  • ARDS
  • SARS-COV-2
  • AHRF
  • Acute Hypoxemic Respiratory Failure

Additional Relevant MeSH Terms

  • COVID-19