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

March 15, 2024 updated by: QuantumLeap Healthcare Collaborative

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

1500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Valerie Caterinicchia, RN, BSN
          • Phone Number: 205-934-5367
          • Email: val7@uab.edu
        • Principal Investigator:
          • Derek Russell, MD
        • Sub-Investigator:
          • Sheetal Gandotra, MD
    • California
      • Davis, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
        • Contact:
        • Principal Investigator:
          • Timothy Albertson, MD
      • Irvine, California, United States, 92868
        • Recruiting
        • UC Irvine Medical Center
        • Contact:
      • Long Beach, California, United States, 90806
        • Recruiting
        • Long Beach Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • Fady Youseff, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Santhi Kumar, MD
      • Los Angeles, California, United States, 90027
      • Newport Beach, California, United States, 92663
        • Active, not recruiting
        • Hoag Memorial Hospital Presbyterian
      • San Francisco, California, United States, 94115
        • Recruiting
        • University of California San Francisco (UCSF)
        • Contact:
          • Phone Number: 877-827-3222
        • Principal Investigator:
          • Kathleen Liu, MD
        • Principal Investigator:
          • Carolyn Calfee, MD
        • Principal Investigator:
          • Laura Esserman, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
        • Principal Investigator:
          • Ellen Burnham, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center
        • Contact:
        • Principal Investigator:
          • Jonathan Koff, MD
      • Stamford, Connecticut, United States, 06904
        • Active, not recruiting
        • Stamford Health
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University
        • Contact:
        • Principal Investigator:
          • Nathan Cobb, MD
    • Florida
      • Coral Gables, Florida, United States, 33124
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Christopher P Jordan, MD
      • Gainesville, Florida, United States, 32608
        • Active, not recruiting
        • University of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Sara Auld, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Completed
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Completed
        • University of Iowa
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Active, not recruiting
        • University of Michigan
      • Grand Rapids, Michigan, United States, 49503
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Completed
        • Mercy Hospital Springfield
    • Montana
      • Kalispell, Montana, United States, 59901
        • Completed
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Completed
        • Logan Health Medical Center
    • New Jersey
      • Mount Holly, New Jersey, United States, 08060
        • Recruiting
        • Virtua Mount Holly Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emillio Mazza, MD
      • Voorhees, New Jersey, United States, 08043
    • New York
      • Bronx, New York, United States, 10461
        • Completed
        • Montefiore Medical Center
      • New York, New York, United States, 10032
        • Completed
        • Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • Completed
        • University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • D. Clark Files, MD
        • Principal Investigator:
          • Karl Thomas, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospital Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Kenneth Remy, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania (U Penn)
        • Contact:
        • Principal Investigator:
          • Nuala Meyer, MD, MS
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center (Mainline Health)
        • Contact:
        • Contact:
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Main Line Health - Lankenau Medical Center
        • Contact:
        • Principal Investigator:
          • Eliot Friedman, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57109
        • Recruiting
        • Sanford Health
        • Contact:
        • Principal Investigator:
          • Paul Berger, MD
    • Texas
      • Edinburg, Texas, United States, 78539
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • University of Texas MD Anderson Cancer Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Active, not recruiting
        • WVU Medicine

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

A. Pregnant or breastfeeding women (must be documented by a pregnancy test during hospitalization)

B. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history.

C. Comfort measures only.

D. Acute liver disease, or chronic liver disease with a Child-Pugh score greater than 11.

E. Resident for more than six months at a skilled nursing facility.

F. Estimated mortality greater than 50% over the next six months from underlying chronic conditions.

G. Time since requirement for high flow oxygen or ventilation greater than 5 days.

H. Anticipated transfer to another hospital which is not a study site within 72 hours.

I. Patients with either end-stage kidney disease or acute kidney injury who are on dialysis.

J. Co-enrollment in clinical trials of pharmacologic agents requiring an IND.

K. On 3 or more vasopressors.

L. Pre-existing heart failure with a known left ventricular ejection fraction <25% or unstable angina pectoris.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Drug: 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.
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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Drug: 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.
Other Names:
  • Firazyr
Experimental: Apremilast + Standard of Care (CLOSED)
Subjects administered standard of care + apremilast orally , 30 mg bid × 14 days.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Drug: Apremilast
oral, 30 mg bid × 14 days.
Other Names:
  • Otezla
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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Biological: 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.

Other Names:
  • Pulmozyme
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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Drug: Celecoxib
Oral: 400 mg BID for 7 days.
Other Names:
  • celebrex
Drug: Famotidine
Oral: High dose 80 mg QID for 7 days followed by 40 mg BID for a course of 14 days.
Other Names:
  • Pepcid
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
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Biological: IC14
intravenous, 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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Biological: 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.
Other Names:
  • OMS721
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
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Drug: Aviptadil
Inhalation via nebulizer, 100 µg three times (TID) daily for a maximum of 14 days
Other Names:
  • Zyesami
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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Drug: 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.
Other Names:
  • periactin
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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Drug: Cyclosporine
Modified CsA at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.
Other Names:
  • CsA
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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of 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.
Drug: 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.
Other Names:
  • GS-5734
Drug: Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Drug: 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.
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.
Time Frame: Up to 28 days

Time to reach a durable COVID-19 level 4 or less or discharge at COVID-level 4 or lower (except for discharge to another hospital), and time to death (mortality).

Data will be analyzed for 3 groups:

  • All
  • COVID-19 level 6/7 (those intubated immediately)
  • COVID-19 level 5 (high flow oxygen to start)

World Health Organization 9-point ordinal scale:

0. No clinical or virologic evidence of infection

  1. Not hospitalized, no limitations on activities;
  2. Not hospitalized, limitation on activities;
  3. Hospitalized, not requiring supplemental oxygen;
  4. Hospitalized, requiring supplemental oxygen (< 6L by nasal cannula or mask delivery system);
  5. Hospitalized, on non-invasive ventilation or high flow oxygen devices (≥6L per minute, mask or intranasal cannula);
  6. Hospitalized, on invasive mechanical ventilation;
  7. Hospitalized, ventilation plus additional organ support-pressors, RRT, ECMO
  8. Death.
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Up to 28 days
  • Proportion of patients alive in the treatment and control arm at day 7, 14, 21, and 28 (The proportion of patients alive, i.e., alive and still at risk of both reaching level 4 and death is given by the survival function).
  • The cumulative incidence function for mortality.
Up to 28 days
Health care utilization
Time Frame: Up to 28 days
Ventilator-free days
Up to 28 days
Improvement in disease severity
Time Frame: Up to 60 days
  • Sustained recovery which is defined as time to discharge at COVID-level 4 or lower and not subsequently re-admitted to the hospital or die at Day 28 follow-up if discharged before 28 days, and Day 60 follow-up if discharged between 28 to 60 days.
  • % of COVID-19 level 5 who never progress to COVID-19 level 6/7

The measure for recovery is defined as time to reach level 4 or less in the World Health Organization COVID-19 scale for at least 48 hours - without returning to high flow oxygen or intubation, or discharge at COVID level 4 or less except for discharge to another hospital. (0 being minimum and 8 being maximum)
Up to 60 days
Safety: Frequency of serious AEs
Time Frame: Up to 60 days
  • Total grade 3 or higher AEs by arm and total number of patients with grade 3 or higher AEs by arm.
  • Total grade 3 or higher AEs of special interest by arm and total number of patients with grade 3 or higher AEs of special interest by arms (based upon lab assessments)

All AEs will be identified and assessed for severity using the National Cancer Institute - Common Terminology Criteria for Adverse Events v5.0 which provides a grading scale for each AE listed.

Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL*.

Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**.

Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QuantumLeap Healthcare Collaborative

Collaborators

M.D. Anderson Cancer Center
University of Colorado, Denver
University of Pennsylvania
University of Miami
Yale University
University of Alabama at Birmingham
Georgetown University
University of Michigan
Emory University
University of Southern California
University of California, Davis
Wake Forest University Health Sciences
University of California, San Francisco
University of California, Irvine
Kaiser Permanente
University Hospitals Cleveland Medical Center
Hoag Memorial Hospital Presbyterian
West Virginia University
DHR Health Institute for Research and Development
Main Line Health
Sanford Health
Long Beach Memorial Medical Center
Virtua Health
Corewell Health

Investigators

  • Principal Investigator: Carolyn Carolyn, MD, University of California, San Francisco
  • Principal Investigator: Kathleen D Liu, MD, University of California, San Francisco
  • Principal Investigator: Laura Esserman, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

July 31, 2020

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-SPY-COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share data on a case by case basis with appropriate IRB review and review by our Data Safety Monitoring Comittee.

IPD Sharing Time Frame

Post publication or earlier if warranted.

IPD Sharing Access Criteria

Sharing criteria are based on the circumstances of the request and whether the data have been published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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