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TICO: ACTIV-3: Therapeutics for Inpatients With COVID-19

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04501978
Collaborator
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) (Other), University of Copenhagen (Other), Medical Research Council (Other), Kirby Institute (Other), Washington D.C. Veterans Affairs Medical Center (U.S. Fed), AIDS Clinical Trials Group (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH), US Department of Veterans Affairs (U.S. Fed), Prevention and Early Treatment of Acute Lung Injury (PETAL) (Other), Cardiothoracic Surgical Trials Network (CTSN) (Other), Eli Lilly and Company (Industry), Vir Biotechnology, Inc. (Industry), GlaxoSmithKline (Industry), Brii Biosciences Limited (Industry), AstraZeneca (Industry), Molecular Partners AG (Industry), National Institute of Allergy and Infectious Diseases (NIAID) (NIH), Pfizer (Industry)
2,753
Enrollment
147
Locations
2
Arms
34.9
Anticipated Duration (Months)
18.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: LY3819253
  • Drug: Placebo
  • Biological: Remdesivir
  • Biological: VIR-7831
  • Biological: BRII-196/BRII-198
  • Biological: AZD7442
  • Drug: MP0420
  • Drug: PF-07304814
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2753 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19
Actual Study Start Date :
Aug 4, 2020
Actual Primary Completion Date :
Apr 6, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACTIV-3 Drug plus SOC

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

Biological: LY3819253
Participants are no longer being randomized to this intervention.

Biological: Remdesivir
Provided to all study participants as SOC unless contraindicated for an individual patient.

Biological: VIR-7831
Participants are no longer being randomized to this intervention.

Biological: BRII-196/BRII-198
Participants are no longer being randomized to this intervention.

Biological: AZD7442
Participants are no longer being randomized to this intervention.
Other Names:
  • AZD8895 + AZD1061

    • Drug: MP0420
    Participants are no longer being randomized to this intervention.
    Other Names:
  • ensovibep

    • Drug: PF-07304814
    250 mg per day for 5 days. Administered as a constant rate intravenous infusion. Suspended: Participants are not currently being randomized to this intervention.
    Placebo Comparator: Placebo plus SOC

    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

    Drug: Placebo
    Commercially available 0.9% sodium chloride solution. Administered by IV infusion

    Biological: Remdesivir
    Provided to all study participants as SOC unless contraindicated for an individual patient.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. All-cause mortality [Thru Day 90]

    2. Composite of time to sustained recovery and mortality [Thru Day 90]

    3. Days alive outside short-term acute care hospital [Up to Day 90]

    4. 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.

    5. 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.

    6. Incidence of clinical organ failure [Thru Day 28]

    7. Composite of death or serious clinical COVID-19 related events [Thru Day 90]

    8. Composite of cardiovascular events and thromboembolic events [Thru Day 90]

    9. Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death [Thru Days 5 and 28]

    10. Incidence of infusion reactions [Thru Day 0]

    11. Composite of SAEs or death [Thru 18 months]

    12. Change in SARS-CoV-2 neutralizing antibody levels [Baseline to Days 1, 3, 5, 28 and 90]

    13. Change in overall titers of antibodies [Baseline to Days 1, 3, 5, 28 and 90]

    14. Change in neutralizing antibody levels [Baseline to Days 1, 3, 5, 28 and 90]

    15. 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

    16. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue Tucson Arizona United States 85719
    2 Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave. Tucson Arizona United States 85723
    3 Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304 Chula Vista California United States 91911
    4 Community Regional Medical Center (Site 203-005), 2823 Fresno Street Fresno California United States 93701
    5 Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1 La Mesa California United States 91942
    6 VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street Loma Linda California United States 92357
    7 VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2) Long Beach California United States 90822
    8 Keck Hospital of USC (Site 301-020), 1500 San Pablo Street Los Angeles California United States 90033
    9 Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd. Los Angeles California United States 90048
    10 Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza Los Angeles California United States 90095
    11 Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way Mather California United States 95655
    12 Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive Newport Beach California United States 92663
    13 Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue Palo Alto California United States 94304
    14 UC Davis Health (Site 203-004), 2315 Stockton Blvd. Sacramento California United States 95817
    15 VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive San Diego California United States 92161
    16 UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St. San Francisco California United States 94115
    17 San Francisco VAMC (Site 074-002), 4150 Clement St. San Francisco California United States 94121
    18 UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave. San Francisco California United States 94143
    19 Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr. Stanford California United States 94305
    20 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building Torrance California United States 90502
    21 University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue Aurora Colorado United States 80045
    22 Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic) Denver Colorado United States 80204
    23 National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street Denver Colorado United States 80206
    24 West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue West Haven Connecticut United States 06516
    25 MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW Washington District of Columbia United States 20007
    26 MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW. Washington District of Columbia United States 20010
    27 Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW Washington District of Columbia United States 20422
    28 Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104 Bay Pines Florida United States 33744
    29 Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street Clearwater Florida United States 33756
    30 North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road Gainesville Florida United States 32608-1197
    31 Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street Hollywood Florida United States 33021
    32 Miami VAMC (Site 074-003), 1201 NW 16 Street Miami Florida United States 33125
    33 Hillsborough County Health Department, University of South Florida (Site 032-001) Tampa Florida United States 33602
    34 Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE Atlanta Georgia United States 30322
    35 Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard Fort Wayne Indiana United States 46804
    36 Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue Topeka Kansas United States 66604
    37 University of Kentucky Hospital (Site 210-004), 1000 South Limestone St. Lexington Kentucky United States 40536
    38 Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway New Orleans Louisiana United States 70121
    39 University of Maryland Medical Center (Site 301-019), 22 South Greene Street Baltimore Maryland United States 21201
    40 Massachusetts General Hospital (Site 202-002), 55 Fruit Street Boston Massachusetts United States 02114
    41 Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave. Boston Massachusetts United States 02215
    42 Baystate Medical Center (Site 201-001), 759 Chestnut Street Springfield Massachusetts United States 01199
    43 University of Michigan (Site 205-001), 1500 East Medical Center Drive Ann Arbor Michigan United States 48109
    44 Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd. Detroit Michigan United States 48202
    45 Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100 Minneapolis Minnesota United States 55407
    46 Hennepin Healthcare (Site 027-001), 701 Park Avenue Minneapolis Minnesota United States 55415
    47 Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70 Minneapolis Minnesota United States 55417
    48 M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE. Minneapolis Minnesota United States 55455
    49 University of Mississippi Medical Center (Site 202-005), 2500 North State Street Jackson Mississippi United States 39216
    50 VA St. Louis Healthcare System (Site 074-027), 915 North Grand Blvd., Rm. C201 Saint Louis Missouri United States 63106
    51 Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive Lebanon New Hampshire United States 03756
    52 Cooper University Hospital (Site 019-001), One Cooper Plaza Camden New Jersey United States 08103
    53 Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street Bronx New York United States 10451
    54 Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road Bronx New York United States 10461
    55 Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street Bronx New York United States 10467
    56 SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave. Brooklyn New York United States 11203
    57 Maimonides Medical Center (Site 033-002), 4802 10th Avenue Brooklyn New York United States 11219
    58 Ichan School of Medicine at Mount Sinai (Site 301-012), One Gustave L. Levy Place, Box 1620 New York New York United States 10029
    59 Duke University Hospital (Site 301-006), 2301 Erwin Road Durham North Carolina United States 27710
    60 Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd Winston-Salem North Carolina United States 27157
    61 University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave. Cincinnati Ohio United States 45219
    62 University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue Cleveland Ohio United States 44106
    63 Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue Cleveland Ohio United States 44111
    64 Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue Cleveland Ohio United States 44195
    65 Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road Garfield Heights Ohio United States 44125
    66 Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd. Portland Oregon United States 97239-3098
    67 Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road Portland Oregon United States 97239
    68 UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street Pittsburgh Pennsylvania United States 15213
    69 UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street Pittsburgh Pennsylvania United States 15213
    70 UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue Pittsburgh Pennsylvania United States 15232
    71 Rhode Island Hospital (Site 080-036), 593 Eddy Street Providence Rhode Island United States 02903
    72 The Miriam Hospital (Site 080-039), 164 Summit Ave. Providence Rhode Island United States 02906
    73 VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave. Providence Rhode Island United States 02908
    74 Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street Charleston South Carolina United States 29401
    75 MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214 Charleston South Carolina United States 29425
    76 MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway Florence South Carolina United States 29505
    77 VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South Nashville Tennessee United States 37212
    78 Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive Nashville Tennessee United States 37232
    79 Hendrick Medical Center (Site 080-014), 1900 Pine Street Abilene Texas United States 79601
    80 CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street Corpus Christi Texas United States 78404
    81 Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd Dallas Texas United States 75235
    82 UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor Dallas Texas United States 75235
    83 Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave. Dallas Texas United States 75246
    84 Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street Houston Texas United States 77030
    85 Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd. Houston Texas United States 77030
    86 Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266 Houston Texas United States 77030
    87 CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave. Longview Texas United States 75601
    88 Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street Murray Utah United States 84107
    89 University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207 Salt Lake City Utah United States 84108
    90 LDS Hospital (Site 211-004), 8th Ave. C Street Salt Lake City Utah United States 84143
    91 University of Virginia Health Systems (Site 301-021), 1215 Lee Street Charlottesville Virginia United States 22903
    92 Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street Richmond Virginia United States 23298
    93 Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue Roanoke Virginia United States 24014
    94 Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd. Salem Virginia United States 24153
    95 Harborview Medical Center (Site 208-001), 325 9th Avenue Seattle Washington United States 98104
    96 Swedish Hospital First Hill (Site 208-005), 747 Broadway Seattle Washington United States 98122
    97 University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street Seattle Washington United States 98195
    98 West Virginia University (Site 301-023), One Medical Center Drive Morgantown West Virginia United States 26506
    99 Hospital Italiano de Buenos Aires (Site 611-002), Pres. Ttd. Gral. Juan Domingo Perón 4190 Buenos Aires Argentina C1199ABB
    100 Hospital General de Agudos Dr. JM Ramos Mejia (Site 611-001), Urquiza 609 Ciudad Autonoma de Buenos Aire Argentina C1221ADC
    101 Centro de Educación Médica e Investigaciones Clinicas "Norberto Quirno" CEMIC (Site 611-021), Av. Cnel. Díaz 2423 á Ciudad Autonoma de Buenos Aire Argentina
    102 Aalborg Hospital (Site 625-005), Hobrovej 18 Aalborg Denmark 9000
    103 Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99 Aarhus N Denmark 8200
    104 Righospitalet (Site 625-006), Blegdamsvej 9, Copenhagen Ø Denmark 2100
    105 Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23 Copenhagen Denmark 2400
    106 Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75 Herlev Denmark 2730
    107 Nordsjællands Hospital (Site 625-009), Dyrehavevej 29 Hillerød Denmark 3400
    108 Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30 Hvidovre Denmark 2650
    109 Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24 Kolding Denmark 6000
    110 Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4 Odense Denmark 5000
    111 Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10 Roskilde Denmark 4000
    112 AIDS and Clinical Immunology Research Center (Site 627-201), Infectious Diseases, 16 Al. Kazbegi Avenue Tbilisi Georgia 0160
    113 Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana Alexandroupolis Evros Greece 68131
    114 Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47 Athens Greece 106 76
    115 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 115 27
    116 3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave. Athens Greece 115 27
    117 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 124 62
    118 Chennai Antiviral Research and Treatment Clinical Research Site (Site 612-402), VHS-IDMC, Voluntary Health Services, Rajiv Gandhi Salai, Taramani Chennai Tamil Nadu India 600113
    119 Medical Centre, Voluntary Health Services (Site 612-402), Rajiv Gandhi Salai, Taramani Chennai Tamil Nadu India 600113
    120 Hospital General Dr. Aurelio Valdivieso (Site 653-004), Calzada Porfirio Díaz No. 400 Oaxaca de Juarez Oaxaca Mexico 68050
    121 Hospital General Dr. Manuel Gea González (Site 653-003), Av. Calzada de Tlalpan 4800, Colonia Belisario Domínguez Sec XVI Alcaldía Tlalpan Mexico City Mexico 14080
    122 Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán (Site 653-001), Av Vasco de Quiroga #15 Belisario Domínguez Secc XVI, Col. Belisario Domínguez Sección XVI, Alcaldía Tlalpan Mexico City Mexico 14080
    123 Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas" (Site 653-002), Calzada de Tlapan No. 4502, Col. Belisario Domínguez Sección XVI Alcaldía Tlalpan Mexico City Mexico 14080
    124 Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC) (Site 634-701), Instituto Nacional de Saúde (INS), Rua da Costa do Sol, 178, Polana Caniço B Maputo Mozambique
    125 Institute of Human Virology Nigeria (IHVN) (Site 612-601), Plot 252, Herbert Macaulay Way, Central Business District Abuja Nigeria
    126 Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37 Warsaw Poland 01-201
    127 Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng Singapore Singapore 308433
    128 Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n Badalona Barcelona Spain 08916
    129 Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80 Lleida Leida Spain 25198
    130 Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29 Barcelona Spain 08003
    131 Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129 Barcelona Spain 08035
    132 Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170 Barcelona Spain 08036
    133 Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n Barcelona Spain 08907
    134 Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46 Madrid Spain 28017
    135 Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN Madrid Spain 28040
    136 UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal Madrid Spain 28046
    137 University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100 Zürich Zurich Switzerland 8091
    138 MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital Entebbe Uganda
    139 Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160 Gulu Uganda
    140 Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill Kampala Uganda
    141 St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146 Kampala Uganda
    142 Lira Regional Referral Hospital (Site 634-605) Lira Uganda
    143 Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556 Masaka Uganda
    144 Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302), Department of Therapy #1, Hetmana Mazepy str. 114 Ivano-Frankivs'k Ukraine 76018
    145 Royal Victoria Infirmary (Site 634-007), Queen Victoria Road Newcastle Upon Tyne Northumbria United Kingdom NE1 4LP
    146 Royal Free Hospital (Site 634-006), Pond Street, Hampstead London United Kingdom NW3 2QG
    147 Guy's and St. Thomas' NHS Foundation Trust (Site 634-011) London United Kingdom SE1 7EH

    Sponsors and Collaborators

    • University of Minnesota
    • International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
    • University of Copenhagen
    • Medical Research Council
    • Kirby Institute
    • Washington D.C. Veterans Affairs Medical Center
    • AIDS Clinical Trials Group
    • National Heart, Lung, and Blood Institute (NHLBI)
    • US Department of Veterans Affairs
    • Prevention and Early Treatment of Acute Lung Injury (PETAL)
    • Cardiothoracic Surgical Trials Network (CTSN)
    • Eli Lilly and Company
    • Vir Biotechnology, Inc.
    • GlaxoSmithKline
    • Brii Biosciences Limited
    • AstraZeneca
    • Molecular Partners AG
    • National Institute of Allergy and Infectious Diseases (NIAID)
    • Pfizer

    Investigators

    • Principal Investigator: Prof. Jens Lundgren, INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
    • Study Chair: Prof. James Neaton, INSIGHT Statistical and Coordinating Centre, University of Minnesota

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT04501978
    Other Study ID Numbers:
    • 014 / ACTIV-3
    First Posted:
    Aug 6, 2020
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Minnesota
    COVID-19
    COVID 19
    Coronaviridae Infections
    Coronavirus Infections
    RNA Virus Infections
    Virus Diseases
    Nidovirales Infections
    SARS-CoV-2
    SARS Coronavirus
    ACTIV-3
    ACTIV3
    Additional relevant MeSH terms:
    COVID-19
    Remdesivir
    Bamlanivimab

    Study Results

    No Results Posted as of Aug 16, 2022