ACTIV-3: Therapeutics for Inpatients With COVID-19

Phase 3

Completed

• Conditions: Covid19
• Interventions: Biological: LY3819253; Drug: Placebo; Biological: Remdesivir; Biological: VIR-7831; Biological: BRII-196/BRII-198; Biological: AZD7442; Drug: MP0420; Drug: PF-07304814

• Registration Number: NCT04501978
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Detailed Description

This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression.

The protocol is for a randomized, blinded, controlled platform study that allows investigational drugs to be added and dropped during the course of the study. This allows for efficient testing of new drugs against placebo and standard of care (SOC) treatment within the same study. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo.

Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: Participants without organ failure (severity stratum 1); and participants with organ failure (severity stratum 2).

An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. For investigational drugs with minimal pre-existing safety knowledge, the pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. For the study of each agent, at the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5.

Both ordinal outcomes are used to assess futility because it is currently unclear whether the investigational agents under study will primarily influence non-pulmonary outcomes, for which risk is increased with SARS-CoV-2 infection, in part, through mechanisms that may be different from those that influence pulmonary outcomes.

For investigational agents passing this futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm or futility for the investigational agent. Participants will be followed for 18 months following randomization.

The international trials within this protocol will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-03
• Study Start: 2020-08-04
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-06
• Primary Completion: 2022-04-06
• Study Completion: 2023-07-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2753

Inclusion Criteria

• Signed informed consent.
• Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.
• Symptoms of COVID-19 for ≤ 12 days.
• Require admission to hospital for acute medical care (not for purely public health or quarantine purposes).

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Exclusion Criteria

• Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization.

• Patients not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 of the study. Co-enrollment in certain trials that compare recommended Standard of Care treatments may be allowed, based on the opinion of the study leadership team.

• Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.

• Patients considered unable to participate in study procedures.

• Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to acknowledge strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 months of the study.

• Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 5 weeks of the study (PF-07304814 investigational agent).

• Pregnant women (PF-07304814 investigational agents).

• Nursing mothers (PF-07304814 investigational agents).

• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 months of the study.

• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 5 weeks of the study (PF-07304814 investigational agent).

• Presence at study enrollment of any of the following:

  1. stroke
  2. meningitis
  3. encephalitis
  4. myelitis
  5. myocardial ischemia
  6. myocarditis
  7. pericarditis
  8. symptomatic congestive heart failure
  9. arterial or deep venous thrombosis or pulmonary embolism

• Current or imminent requirement for any of the following:

  1. invasive mechanical ventilation
  2. ECMO (extracorporeal membrane oxygenation)
  3. Mechanical circulatory support
  4. vasopressor therapy
  5. commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).

• Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure (PF-07304814 investigational agent).

• Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent).

• Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine (PF-07304814 investigational agent).

• Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism (Prior to initial futility assessment of PF-07304814 investigational agent).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACTIV-3 Drug plus SOC	VIR-7831	Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
ACTIV-3 Drug plus SOC	LY3819253	Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
ACTIV-3 Drug plus SOC	Remdesivir	Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
ACTIV-3 Drug plus SOC	BRII-196/BRII-198	Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
ACTIV-3 Drug plus SOC	AZD7442	Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
ACTIV-3 Drug plus SOC	MP0420	Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
Placebo plus SOC	Placebo	The placebo arm may be pooled across more than one experimental arm if multiple investigational drugs are available to be tested at the same time. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Placebo plus SOC	Remdesivir	The placebo arm may be pooled across more than one experimental arm if multiple investigational drugs are available to be tested at the same time. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
ACTIV-3 Drug plus SOC	PF-07304814	Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC

Primary Outcome Measures

Name	Time	Method
Time from randomization to sustained recovery	Up to Day 90	Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	Thru Day 90
Composite of time to sustained recovery and mortality	Thru Day 90
Days alive outside short-term acute care hospital	Up to Day 90
Pulmonary ordinal outcome	Days 1-7, 14 and 28	Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Pulmonary+ ordinal outcome	Days 1-7	Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Incidence of clinical organ failure	Thru Day 28
Composite of death or serious clinical COVID-19 related events	Thru Day 90
Composite of cardiovascular events and thromboembolic events	Thru Day 90
Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death	Thru Days 5 and 28
Incidence of infusion reactions	Thru Day 0
Composite of SAEs or death	Thru 18 months
Change in SARS-CoV-2 neutralizing antibody levels	Baseline to Days 1, 3, 5, 28 and 90
Change in overall titers of antibodies	Baseline to Days 1, 3, 5, 28 and 90
Change in neutralizing antibody levels	Baseline to Days 1, 3, 5, 28 and 90
Incidence of home use of supplemental oxygen above pre-morbid oxygen use	18 months	Measured as: Alive at home and no use of continuous supplemental oxygen for an uninterrupted 14 day period
Incidence of no home use of supplemental oxygen above pre-morbid oxygen use	14 days	Measured as: Alive at home for an uninterrupted 14 day period and no use of continuous supplemental oxygen at end of 14 day time period.

Trial Locations

Locations (135)

University of Maryland Medical Center (Site 301-019), 22 South Greene Street; 🇺🇸 Baltimore, Maryland, United States

Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza; 🇺🇸 Los Angeles, California, United States

Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard; 🇺🇸 Fort Wayne, Indiana, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building; 🇺🇸 Torrance, California, United States

Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street; 🇺🇸 Clearwater, Florida, United States

UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue; 🇺🇸 Pittsburgh, Pennsylvania, United States

CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street; 🇺🇸 Corpus Christi, Texas, United States

West Virginia University (Site 301-023), One Medical Center Drive; 🇺🇸 Morgantown, West Virginia, United States

Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37; 🇵🇱 Warsaw, Poland

Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.; 🇺🇸 Boston, Massachusetts, United States

Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street; 🇺🇸 Houston, Texas, United States

Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.; 🇺🇸 Houston, Texas, United States

Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266; 🇺🇸 Houston, Texas, United States

Harborview Medical Center (Site 208-001), 325 9th Avenue; 🇺🇸 Seattle, Washington, United States

Swedish Hospital First Hill (Site 208-005), 747 Broadway; 🇺🇸 Seattle, Washington, United States

University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street; 🇺🇸 Seattle, Washington, United States

VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive; 🇺🇸 San Diego, California, United States

Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556; 🇺🇬 Masaka, Uganda

MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital; 🇺🇬 Entebbe, Uganda

St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146; 🇺🇬 Kampala, Uganda

Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill; 🇺🇬 Kampala, Uganda

San Francisco VAMC (Site 074-002), 4150 Clement St.; 🇺🇸 San Francisco, California, United States

UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.; 🇺🇸 San Francisco, California, United States

UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.; 🇺🇸 San Francisco, California, United States

Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100; 🇺🇸 Minneapolis, Minnesota, United States

Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70; 🇺🇸 Minneapolis, Minnesota, United States

VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive; 🇺🇸 Nashville, Tennessee, United States

University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207; 🇺🇸 Salt Lake City, Utah, United States

LDS Hospital (Site 211-004), 8th Ave. C Street; 🇺🇸 Salt Lake City, Utah, United States

Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.; 🇺🇸 Detroit, Michigan, United States

Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99; 🇩🇰 Aarhus N, Denmark

Righospitalet (Site 625-006), Blegdamsvej 9,; 🇩🇰 Copenhagen Ø, Denmark

Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30; 🇩🇰 Hvidovre, Denmark

Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24; 🇩🇰 Kolding, Denmark

Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4; 🇩🇰 Odense, Denmark

Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10; 🇩🇰 Roskilde, Denmark

Community Regional Medical Center (Site 203-005), 2823 Fresno Street; 🇺🇸 Fresno, California, United States

Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive; 🇺🇸 Newport Beach, California, United States

Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way; 🇺🇸 Mather, California, United States

Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1; 🇺🇸 La Mesa, California, United States

VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street; 🇺🇸 Loma Linda, California, United States

VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2); 🇺🇸 Long Beach, California, United States

Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.; 🇺🇸 Los Angeles, California, United States

MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW; 🇺🇸 Washington, District of Columbia, United States

Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW; 🇺🇸 Washington, District of Columbia, United States

West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue; 🇺🇸 West Haven, Connecticut, United States

MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.; 🇺🇸 Washington, District of Columbia, United States

Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104; 🇺🇸 Bay Pines, Florida, United States

Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street; 🇺🇸 Hollywood, Florida, United States

Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE; 🇺🇸 Atlanta, Georgia, United States

Miami VAMC (Site 074-003), 1201 NW 16 Street; 🇺🇸 Miami, Florida, United States

Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue; 🇺🇸 Topeka, Kansas, United States

Hennepin Healthcare (Site 027-001), 701 Park Avenue; 🇺🇸 Minneapolis, Minnesota, United States

Massachusetts General Hospital (Site 202-002), 55 Fruit Street; 🇺🇸 Boston, Massachusetts, United States

Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive; 🇺🇸 Lebanon, New Hampshire, United States

VA St. Louis Healthcare System (Site 074-027), 915 North Grand Blvd., Rm. C201; 🇺🇸 Saint Louis, Missouri, United States

University of Mississippi Medical Center (Site 202-005), 2500 North State Street; 🇺🇸 Jackson, Mississippi, United States

Cooper University Hospital (Site 019-001), One Cooper Plaza; 🇺🇸 Camden, New Jersey, United States

Maimonides Medical Center (Site 033-002), 4802 10th Avenue; 🇺🇸 Brooklyn, New York, United States

University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave.; 🇺🇸 Cincinnati, Ohio, United States

Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road; 🇺🇸 Garfield Heights, Ohio, United States

Duke University Hospital (Site 301-006), 2301 Erwin Road; 🇺🇸 Durham, North Carolina, United States

The Miriam Hospital (Site 080-039), 164 Summit Ave.; 🇺🇸 Providence, Rhode Island, United States

University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue; 🇺🇸 Cleveland, Ohio, United States

UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street; 🇺🇸 Pittsburgh, Pennsylvania, United States

Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue; 🇺🇸 Cleveland, Ohio, United States

Hendrick Medical Center (Site 080-014), 1900 Pine Street; 🇺🇸 Abilene, Texas, United States

UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street; 🇺🇸 Pittsburgh, Pennsylvania, United States

Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd; 🇺🇸 Dallas, Texas, United States

UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor; 🇺🇸 Dallas, Texas, United States

Rhode Island Hospital (Site 080-036), 593 Eddy Street; 🇺🇸 Providence, Rhode Island, United States

University of Virginia Health Systems (Site 301-021), 1215 Lee Street; 🇺🇸 Charlottesville, Virginia, United States

Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75; 🇩🇰 Herlev, Denmark

MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway; 🇺🇸 Florence, South Carolina, United States

Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23; 🇩🇰 Copenhagen, Denmark

Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street; 🇺🇸 Murray, Utah, United States

Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.; 🇺🇸 Salem, Virginia, United States

Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue; 🇺🇸 Roanoke, Virginia, United States

Aalborg Hospital (Site 625-005), Hobrovej 18; 🇩🇰 Aalborg, Denmark

Nordsjællands Hospital (Site 625-009), Dyrehavevej 29; 🇩🇰 Hillerød, Denmark

Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47; 🇬🇷 Athens, Greece

1st Respiratory Medicine Dept., Athens University Medical School (Site 635-015), Athens Hospital for Diseases of the Chest "Sotiria Hospital", 152 Mesogeion Ave.; 🇬🇷 Athens, Greece

Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana; 🇬🇷 Alexandroupolis, Evros, Greece

3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave.; 🇬🇷 Athens, Greece

Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170; 🇪🇸 Barcelona, Spain

Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80; 🇪🇸 Lleida, Leida, Spain

Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160; 🇺🇬 Gulu, Uganda

Lira Regional Referral Hospital (Site 634-605); 🇺🇬 Lira, Uganda

Royal Free Hospital (Site 634-006), Pond Street, Hampstead; 🇬🇧 London, United Kingdom

UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal; 🇪🇸 Madrid, Spain

Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129; 🇪🇸 Barcelona, Spain

Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n; 🇪🇸 Barcelona, Spain

University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue; 🇺🇸 Aurora, Colorado, United States

Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic); 🇺🇸 Denver, Colorado, United States

National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street; 🇺🇸 Denver, Colorado, United States

Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.; 🇺🇸 Portland, Oregon, United States

Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road; 🇺🇸 Portland, Oregon, United States

Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue; 🇺🇸 Palo Alto, California, United States

Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.; 🇺🇸 Dallas, Texas, United States

Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN; 🇪🇸 Madrid, Spain

Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue; 🇺🇸 Tucson, Arizona, United States

Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave.; 🇺🇸 Tucson, Arizona, United States

Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304; 🇺🇸 Chula Vista, California, United States

Keck Hospital of USC (Site 301-020), 1500 San Pablo Street; 🇺🇸 Los Angeles, California, United States

Baystate Medical Center (Site 201-001), 759 Chestnut Street; 🇺🇸 Springfield, Massachusetts, United States

M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE.; 🇺🇸 Minneapolis, Minnesota, United States

Ichan School of Medicine at Mount Sinai (Site 301-012), One Gustave L. Levy Place, Box 1620; 🇺🇸 New York, New York, United States

SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave.; 🇺🇸 Brooklyn, New York, United States

Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue; 🇺🇸 Cleveland, Ohio, United States

VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave.; 🇺🇸 Providence, Rhode Island, United States

CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave.; 🇺🇸 Longview, Texas, United States

Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng; 🇸🇬 Singapore, Singapore

Attikon University General Hospital (Site 635-009), 4th Dept. of Internal Medicine, Medical School, National and Kapodistrian University of Athens, 1 Rimini St., Haidari; 🇬🇷 Athens, Greece

Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29; 🇪🇸 Barcelona, Spain

University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100; 🇨🇭 Zürich, Zurich, Switzerland

Royal Victoria Infirmary (Site 634-007), Queen Victoria Road; 🇬🇧 Newcastle Upon Tyne, Northumbria, United Kingdom

Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd; 🇺🇸 Winston-Salem, North Carolina, United States

UC Davis Health (Site 203-004), 2315 Stockton Blvd.; 🇺🇸 Sacramento, California, United States

Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street; 🇺🇸 Charleston, South Carolina, United States

Hillsborough County Health Department, University of South Florida (Site 032-001); 🇺🇸 Tampa, Florida, United States

University of Michigan (Site 205-001), 1500 East Medical Center Drive; 🇺🇸 Ann Arbor, Michigan, United States

MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214; 🇺🇸 Charleston, South Carolina, United States

Institute of Human Virology Nigeria (IHVN) (Site 612-601), Plot 252, Herbert Macaulay Way, Central Business District; 🇳🇬 Abuja, Nigeria

North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road; 🇺🇸 Gainesville, Florida, United States

Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway; 🇺🇸 New Orleans, Louisiana, United States

Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street; 🇺🇸 Bronx, New York, United States

Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street; 🇺🇸 Bronx, New York, United States

Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road; 🇺🇸 Bronx, New York, United States

Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street; 🇺🇸 Richmond, Virginia, United States

University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.; 🇺🇸 Lexington, Kentucky, United States

Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.; 🇺🇸 Stanford, California, United States

Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n; 🇪🇸 Badalona, Barcelona, Spain

Guy's and St. Thomas' NHS Foundation Trust (Site 634-011); 🇬🇧 London, United Kingdom