Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE

Completed · Phase 4

Conditions studied: Covid19

In brief

This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19 positive inpatients

Key facts

Study ID

NCT04505774

Run by

Matthew Neal MD

People needed

3591

Starts

2020-09-04

Expected to finish

2024-01-26

Last updated by the study team

2024-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age
• Hospitalized for COVID-19
• Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
• Expected to require hospitalization for > 72 hours

You may not qualify if…

• Imminent death
• Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
• Pregnancy
• Inclusion Criteria for Arm E
• Inclusion criteria contained in the master protocol in addition to the following:
• Moderate illness severity - defined as non-ICU level of care at the time of randomization (not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO) OR Severe illness severity - defined as ICU level of care at the time of randomization (receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)
• For moderate illness severity, participants are required to meet one or more of the following risk criteria:
• Age ≥ 65 years or
• ≥2 of the following -
• O2 supplementation > 2 liters per minute
• BMI ≥ 35
• GFR ≤ 60
• History of Type 2 diabetes
• History of heart failure (regardless of ejection fraction)
• D dimer ≥ 2x the site's upper limit of normal (ULN)
• Troponin ≥ 2x the site's ULN
• BNP≥100 pg/mL or NT-proBNP≥300 pg/mL
• CRP ≥50 mg/L
• Exclusion Criteria for Arm E
• Exclusion criteria contained in the master protocol, and
• Any condition that, in the opinion of the investigator, precludes the use of crizanlizumab such as uncontrolled bleeding or severe anemia (hemoglobin<4 g/dL)
• Open label treatment with crizanlizumab within the past three months
• Inclusion Criteria for Arm F
• Inclusion criteria contained in the master protocol in addition to the following:
• Moderate illness severity - defined as non-ICU level of care at the time of randomization (not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO)) OR Severe illness severity - defined as ICU level of care at the time of randomization (receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Fontana — Fontana, California, United States
• Kaiser Permanente Los Angeles — Los Angeles, California, United States
• Smidt Heart Institute at Cedars-Sinai — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UC San Diego Hillcrest — San Diego, California, United States
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States
• UCSF San Francisco — San Francisco, California, United States
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• St. Mary's Hospital & Regional Medical Center — Grand Junction, Colorado, United States
• Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Memorial Hospital — Jacksonville, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• Emory — Atlanta, Georgia, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• Queens Medical Center — Honolulu, Hawaii, United States
• Memorial Hospital — Belleville, Illinois, United States
• Cook County Health — Chicago, Illinois, United States
• University of Illinois at Chicago Health (UIH) — Chicago, Illinois, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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