I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
NCT ID: NCT04488081
Last Updated: 2024-03-19
Study Results
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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RECRUITING
PHASE2
1500 participants
INTERVENTIONAL
2020-07-31
2030-07-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
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.
Dexamethasone
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.
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 + 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.
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.
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 + 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.
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
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 + Standard of Care (CLOSED)
Subjects administered standard of care + apremilast orally , 30 mg bid × 14 days.
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Apremilast
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.
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
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/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.
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
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 + 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
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
IC14
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.
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
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.
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
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Aviptadil
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.
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
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 + 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.
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.
Dexamethasone
6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Cyclosporine
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
University of Pennsylvania
OTHER
Emory University
OTHER
University of Alabama at Birmingham
OTHER
University of Colorado, Denver
OTHER
University of Southern California
OTHER
Yale University
OTHER
Wake Forest University Health Sciences
OTHER
Sanford Health
OTHER
Long Beach Memorial Medical Center
OTHER
Georgetown University
OTHER
University of California, Davis
OTHER
Hoag Memorial Hospital Presbyterian
OTHER
Main Line Health
OTHER
DHR Health Institute for Research and Development
OTHER
University of California, Irvine
OTHER
Corewell Health
UNKNOWN
Kaiser Permanente
OTHER
University of Michigan
OTHER
West Virginia University
OTHER
University of Miami
OTHER
University Hospitals Cleveland Medical Center
OTHER
Virtua Health
OTHER
M.D. Anderson Cancer Center
OTHER
QuantumLeap Healthcare Collaborative
OTHER
Responsible Party
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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
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
Sioux 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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
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.
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.
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.
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.
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.
Related Links
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Clinical trial design during and beyond the pandemic: the I-SPY COVID trial, 20Jan2022
Other Identifiers
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I-SPY-COVID
Identifier Type: -
Identifier Source: org_study_id
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