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

NCT ID: NCT04488081

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2030-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Platform Trial, Bayesian Design, from 2 arms up to 8 arms
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Cenicriviroc

Intervention Type DRUG

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 + 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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Icatibant

Intervention Type DRUG

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 + Standard of Care (CLOSED)

Subjects administered standard of care + apremilast orally , 30 mg bid × 14 days.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Apremilast

Intervention Type DRUG

oral, 30 mg bid × 14 days.

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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

dornase alfa

Intervention Type BIOLOGICAL

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/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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Celecoxib

Intervention Type DRUG

Oral: 400 mg BID for 7 days.

Famotidine

Intervention Type DRUG

Oral: High dose 80 mg QID for 7 days followed by 40 mg BID for a course of 14 days.

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

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

IC14

Intervention Type BIOLOGICAL

intravenous, 4 mg/kg on day 1, followed by 2 mg/kg on days 2, 3, 4

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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

narsoplimab

Intervention Type BIOLOGICAL

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.

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

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Aviptadil

Intervention Type DRUG

Inhalation via nebulizer, 100 µg three times (TID) daily for a maximum of 14 days

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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Cyproheptadine

Intervention Type DRUG

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 + 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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

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.

Dexamethasone

Intervention Type DRUG

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Cyclosporine

Intervention Type DRUG

Modified CsA at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.

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.

Group Type EXPERIMENTAL

Imatinib Mesylate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Dexamethasone

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Apremilast

oral, 30 mg bid × 14 days.

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Celecoxib

Oral: 400 mg BID for 7 days.

Intervention Type DRUG

Famotidine

Oral: High dose 80 mg QID for 7 days followed by 40 mg BID for a course of 14 days.

Intervention Type DRUG

IC14

intravenous, 4 mg/kg on day 1, followed by 2 mg/kg on days 2, 3, 4

Intervention Type BIOLOGICAL

Aviptadil

Inhalation via nebulizer, 100 µg three times (TID) daily for a maximum of 14 days

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

Cyclosporine

Modified CsA at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.

Intervention Type DRUG

Other Intervention Names

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GS-5734 Firazyr Otezla Pulmozyme celebrex Pepcid Zyesami OMS721 periactin CsA

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Sanford Health

OTHER

Sponsor Role collaborator

Long Beach Memorial Medical Center

OTHER

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role collaborator

Main Line Health

OTHER

Sponsor Role collaborator

DHR Health Institute for Research and Development

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

Corewell Health

UNKNOWN

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

West Virginia University

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role collaborator

Virtua Health

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

QuantumLeap Healthcare Collaborative

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolyn Carolyn, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kathleen D Liu, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Laura Esserman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

UC Davis Medical Center

Davis, California, United States

Site Status RECRUITING

UC Irvine Medical Center

Irvine, California, United States

Site Status RECRUITING

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status RECRUITING

Kaiser LAMC

Los Angeles, California, United States

Site Status RECRUITING

University of Southern California

Los Angeles, California, United States

Site Status RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of California San Francisco (UCSF)

San Francisco, California, United States

Site Status RECRUITING

University of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Stamford Health

Stamford, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Georgetown University

Washington D.C., District of Columbia, United States

Site Status RECRUITING

University of Miami

Coral Gables, Florida, United States

Site Status RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status COMPLETED

University of Iowa

Iowa City, Iowa, United States

Site Status COMPLETED

University of Michigan

Ann Arbor, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Corewell Health

Grand Rapids, Michigan, United States

Site Status RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status COMPLETED

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status COMPLETED

Logan Health Medical Center

Kalispell, Montana, United States

Site Status COMPLETED

Virtua Mount Holly Hospital

Mount Holly, New Jersey, United States

Site Status RECRUITING

Virtua Voorhees Hospital

Voorhees Township, New Jersey, United States

Site Status RECRUITING

Columbia University Medical Center

New York, New York, United States

Site Status COMPLETED

University of Rochester Medical Center

Rochester, New York, United States

Site Status COMPLETED

Montefiore Medical Center

The Bronx, New York, United States

Site Status COMPLETED

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

University Hospital Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

University of Pennsylvania (U Penn)

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Lankenau Medical Center (Mainline Health)

Wynnewood, Pennsylvania, United States

Site Status RECRUITING

Main Line Health - Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status RECRUITING

Sanford Health

Sioux Falls, South Dakota, United States

Site Status RECRUITING

DHR Health

Edinburg, Texas, United States

Site Status RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

WVU Medicine

Morgantown, West Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Paul Henderson, PhD

Role: CONTACT

1-925-570-1615

Karyn DiGiorgio, MS

Role: CONTACT

1-415-307-1539

Facility Contacts

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Valerie Caterinicchia, RN, BSN

Role: primary

205-934-5367

Skyler Pearson

Role: primary

916-734-3867

Richard Lee, MD

Role: primary

714-456-7890

Daniel Blevins

Role: primary

562-760-6817

Kenneth Wei, MD

Role: primary

323-783-8191

David Silberstein, MD

Role: backup

3237831009

Melissa Ramos, BSN, RN

Role: primary

818-309-5542

Role: primary

877-827-3222

Tessa Mcspadden

Role: primary

720-848-0609

Trisha Burello, MS

Role: primary

203-737-2848

Amen Hamed

Role: primary

202-444-0895

Karla L Escalona

Role: primary

Christine Spainhour, CCRC

Role: primary

404-778-7850

Malik Khan, MD

Role: primary

866-989-7999

Lissa Ferrant

Role: primary

Kristin Broderick

Role: backup

856-355-1225

Lisa Ferrant

Role: primary

Kristin Broderick

Role: backup

Angela Howell, MD

Role: primary

336-716-5440

Nisha Rao

Role: primary

Lauren Bayne

Role: primary

215-349-5398

Elliot Friedman, MD

Role: primary

484-476-2000

Ebuwa Erebor

Role: backup

Christina Angelucci

Role: primary

Allison Lutz

Role: primary

605-312-6971

Praveen Vijhani, MD

Role: primary

956-342-5413

Lu Cantu

Role: backup

956-362-2396

References

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Files DC, Matthay MA, Calfee CS, Aggarwal NR, Asare AL, Beitler JR, Berger PA, Burnham EL, Cimino G, Coleman MH, Crippa A, Discacciati A, Gandotra S, Gibbs KW, Henderson PT, Ittner CAG, Jauregui A, Khan KT, Koff JL, Lang J, LaRose M, Levitt J, Lu R, McKeehan JD, Meyer NJ, Russell DW, Thomas KW, Eklund M, Esserman LJ, Liu KD; ISPY COVID Adaptive Platform Trial Network; undefined. I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations. BMJ Open. 2022 Jun 6;12(6):e060664. doi: 10.1136/bmjopen-2021-060664.

Reference Type BACKGROUND
PMID: 35667714 (View on PubMed)

Mabrey FL, Martin TR, Calfee CS, Liu KD, LaCombe B, Brown-Swigart L, Discacciati A, Eklund M, Heckbert SR, Matthay MA, Esserman L, Wurfel MM. Anti-CD14 treatment in patients with severe COVID-19: Clinical and biological effects in a Phase 2 randomized open-label adaptive platform clinical trial. CHEST Crit Care. 2025 Mar;3(1):100117. doi: 10.1016/j.chstcc.2024.100117. Epub 2024 Dec 9.

Reference Type DERIVED
PMID: 40462830 (View on PubMed)

Pomponio R, Peterson RA, Owusu M, Slaughter S, Melgar S, Jolley SE, Burnham EL. Phosphatidylethanol measures in patients with severe COVID-19-associated respiratory failure identify a subset with alcohol misuse. Alcohol Clin Exp Res (Hoboken). 2025 Jan;49(1):165-174. doi: 10.1111/acer.15495. Epub 2024 Nov 26.

Reference Type DERIVED
PMID: 39592213 (View on PubMed)

I-SPY COVID Consortium. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial. EClinicalMedicine. 2023 Apr;58:101889. doi: 10.1016/j.eclinm.2023.101889. Epub 2023 Mar 3.

Reference Type DERIVED
PMID: 36883141 (View on PubMed)

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Reference Type DERIVED
PMID: 34473343 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.nature.com/articles/s41591-021-01617-x

Clinical trial design during and beyond the pandemic: the I-SPY COVID trial, 20Jan2022

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I-SPY-COVID

Identifier Type: -

Identifier Source: org_study_id

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