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)
10,000
Enrollment
147
Locations
2
Arms
22.9
Anticipated Duration (Months)
68
Patients Per Site
3
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 DiseaseIntervention/TreatmentPhase
  • 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
Anticipated Enrollment :
10000 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
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell AvenueTucsonArizonaUnited States85719
    2Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave.TucsonArizonaUnited States85723
    3Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304Chula VistaCaliforniaUnited States91911
    4Community Regional Medical Center (Site 203-005), 2823 Fresno StreetFresnoCaliforniaUnited States93701
    5Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1La MesaCaliforniaUnited States91942
    6VA Loma Linda Healthcare System (Site 074-017), 11201 Benton StreetLoma LindaCaliforniaUnited States92357
    7VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2)Long BeachCaliforniaUnited States90822
    8Keck Hospital of USC (Site 301-020), 1500 San Pablo StreetLos AngelesCaliforniaUnited States90033
    9Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.Los AngelesCaliforniaUnited States90048
    10Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood PlazaLos AngelesCaliforniaUnited States90095
    11Sacramento VA Medical Center (Site 074-023), 10535 Hospital WayMatherCaliforniaUnited States95655
    12Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag DriveNewport BeachCaliforniaUnited States92663
    13Palo Alto VAMC (Site 074-005), 3801 Miranda AvenuePalo AltoCaliforniaUnited States94304
    14UC Davis Health (Site 203-004), 2315 Stockton Blvd.SacramentoCaliforniaUnited States95817
    15VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village DriveSan DiegoCaliforniaUnited States92161
    16UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.San FranciscoCaliforniaUnited States94115
    17San Francisco VAMC (Site 074-002), 4150 Clement St.San FranciscoCaliforniaUnited States94121
    18UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.San FranciscoCaliforniaUnited States94143
    19Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.StanfordCaliforniaUnited States94305
    20Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC BuildingTorranceCaliforniaUnited States90502
    21University of Colorado Hospital (Site 204-001), 12605 E. 16th AvenueAuroraColoradoUnited States80045
    22Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)DenverColoradoUnited States80204
    23National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson StreetDenverColoradoUnited States80206
    24West Haven VA Medical Center (Site 025-007), 950 Campbell AvenueWest HavenConnecticutUnited States06516
    25MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NWWashingtonDistrict of ColumbiaUnited States20007
    26MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.WashingtonDistrict of ColumbiaUnited States20010
    27Washington DC VA Medical Center (Site 009-004), 50 Irving Street NWWashingtonDistrict of ColumbiaUnited States20422
    28Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104Bay PinesFloridaUnited States33744
    29Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas StreetClearwaterFloridaUnited States33756
    30North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer RoadGainesvilleFloridaUnited States32608-1197
    31Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson StreetHollywoodFloridaUnited States33021
    32Miami VAMC (Site 074-003), 1201 NW 16 StreetMiamiFloridaUnited States33125
    33Hillsborough County Health Department, University of South Florida (Site 032-001)TampaFloridaUnited States33602
    34Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NEAtlantaGeorgiaUnited States30322
    35Lutheran Medical Group (Site 301-010), 7916 W. Jefferson BoulevardFort WayneIndianaUnited States46804
    36Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th AvenueTopekaKansasUnited States66604
    37University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.LexingtonKentuckyUnited States40536
    38Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson HighwayNew OrleansLouisianaUnited States70121
    39University of Maryland Medical Center (Site 301-019), 22 South Greene StreetBaltimoreMarylandUnited States21201
    40Massachusetts General Hospital (Site 202-002), 55 Fruit StreetBostonMassachusettsUnited States02114
    41Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.BostonMassachusettsUnited States02215
    42Baystate Medical Center (Site 201-001), 759 Chestnut StreetSpringfieldMassachusettsUnited States01199
    43University of Michigan (Site 205-001), 1500 East Medical Center DriveAnn ArborMichiganUnited States48109
    44Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.DetroitMichiganUnited States48202
    45Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100MinneapolisMinnesotaUnited States55407
    46Hennepin Healthcare (Site 027-001), 701 Park AvenueMinneapolisMinnesotaUnited States55415
    47Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70MinneapolisMinnesotaUnited States55417
    48M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE.MinneapolisMinnesotaUnited States55455
    49University of Mississippi Medical Center (Site 202-005), 2500 North State StreetJacksonMississippiUnited States39216
    50VA St. Louis Healthcare System (Site 074-027), 915 North Grand Blvd., Rm. C201Saint LouisMissouriUnited States63106
    51Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center DriveLebanonNew HampshireUnited States03756
    52Cooper University Hospital (Site 019-001), One Cooper PlazaCamdenNew JerseyUnited States08103
    53Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th StreetBronxNew YorkUnited States10451
    54Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester RoadBronxNew YorkUnited States10461
    55Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th StreetBronxNew YorkUnited States10467
    56SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave.BrooklynNew YorkUnited States11203
    57Maimonides Medical Center (Site 033-002), 4802 10th AvenueBrooklynNew YorkUnited States11219
    58Ichan School of Medicine at Mount Sinai (Site 301-012), One Gustave L. Levy Place, Box 1620New YorkNew YorkUnited States10029
    59Duke University Hospital (Site 301-006), 2301 Erwin RoadDurhamNorth CarolinaUnited States27710
    60Wake Forest University Health Sciences (Site 210-001), Medical Center BlvdWinston-SalemNorth CarolinaUnited States27157
    61University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave.CincinnatiOhioUnited States45219
    62University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid AvenueClevelandOhioUnited States44106
    63Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain AvenueClevelandOhioUnited States44111
    64Cleveland Clinic Foundation (Site 207-001), 9500 Euclid AvenueClevelandOhioUnited States44195
    65Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken RoadGarfield HeightsOhioUnited States44125
    66Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.PortlandOregonUnited States97239-3098
    67Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital RoadPortlandOregonUnited States97239
    68UPMC Magee-Womens Hospital (Site 209-003), 300 Halket StreetPittsburghPennsylvaniaUnited States15213
    69UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop StreetPittsburghPennsylvaniaUnited States15213
    70UPMC Shadyside Hospital (Site 209-005), 5230 Centre AvenuePittsburghPennsylvaniaUnited States15232
    71Rhode Island Hospital (Site 080-036), 593 Eddy StreetProvidenceRhode IslandUnited States02903
    72The Miriam Hospital (Site 080-039), 164 Summit Ave.ProvidenceRhode IslandUnited States02906
    73VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave.ProvidenceRhode IslandUnited States02908
    74Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee StreetCharlestonSouth CarolinaUnited States29401
    75MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214CharlestonSouth CarolinaUnited States29425
    76MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico HighwayFlorenceSouth CarolinaUnited States29505
    77VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue SouthNashvilleTennesseeUnited States37212
    78Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center DriveNashvilleTennesseeUnited States37232
    79Hendrick Medical Center (Site 080-014), 1900 Pine StreetAbileneTexasUnited States79601
    80CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth StreetCorpus ChristiTexasUnited States78404
    81Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines BlvdDallasTexasUnited States75235
    82UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd FloorDallasTexasUnited States75235
    83Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.DallasTexasUnited States75246
    84Memorial Hermann Hospital (Site 203-006), 6411 Fannin StreetHoustonTexasUnited States77030
    85Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.HoustonTexasUnited States77030
    86Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266HoustonTexasUnited States77030
    87CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave.LongviewTexasUnited States75601
    88Intermountain Medical Center (Site 211-001), 5121 South Cottonwood StreetMurrayUtahUnited States84107
    89University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207Salt Lake CityUtahUnited States84108
    90LDS Hospital (Site 211-004), 8th Ave. C StreetSalt Lake CityUtahUnited States84143
    91University of Virginia Health Systems (Site 301-021), 1215 Lee StreetCharlottesvilleVirginiaUnited States22903
    92Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall StreetRichmondVirginiaUnited States23298
    93Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview AvenueRoanokeVirginiaUnited States24014
    94Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.SalemVirginiaUnited States24153
    95Harborview Medical Center (Site 208-001), 325 9th AvenueSeattleWashingtonUnited States98104
    96Swedish Hospital First Hill (Site 208-005), 747 BroadwaySeattleWashingtonUnited States98122
    97University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific StreetSeattleWashingtonUnited States98195
    98West Virginia University (Site 301-023), One Medical Center DriveMorgantownWest VirginiaUnited States26506
    99Hospital Italiano de Buenos Aires (Site 611-002), Pres. Ttd. Gral. Juan Domingo Perón 4190Buenos AiresArgentinaC1199ABB
    100Hospital General de Agudos Dr. JM Ramos Mejia (Site 611-001), Urquiza 609Ciudad Autonoma de Buenos AireArgentinaC1221ADC
    101Centro de Educación Médica e Investigaciones Clinicas "Norberto Quirno" CEMIC (Site 611-021), Av. Cnel. Díaz 2423 áCiudad Autonoma de Buenos AireArgentina
    102Aalborg Hospital (Site 625-005), Hobrovej 18AalborgDenmark9000
    103Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99Aarhus NDenmark8200
    104Righospitalet (Site 625-006), Blegdamsvej 9,Copenhagen ØDenmark2100
    105Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23CopenhagenDenmark2400
    106Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75HerlevDenmark2730
    107Nordsjællands Hospital (Site 625-009), Dyrehavevej 29HillerødDenmark3400
    108Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30HvidovreDenmark2650
    109Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24KoldingDenmark6000
    110Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4OdenseDenmark5000
    111Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10RoskildeDenmark4000
    112AIDS and Clinical Immunology Research Center (Site 627-201), Infectious Diseases, 16 Al. Kazbegi AvenueTbilisiGeorgia0160
    113Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, DraganaAlexandroupolisEvrosGreece68131
    114Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47AthensGreece106 76
    1151st Respiratory Medicine Dept., Athens University Medical School (Site 635-015), Athens Hospital for Diseases of the Chest "Sotiria Hospital", 152 Mesogeion Ave.AthensGreece115 27
    1163rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave.AthensGreece115 27
    117Attikon University General Hospital (Site 635-009), 4th Dept. of Internal Medicine, Medical School, National and Kapodistrian University of Athens, 1 Rimini St., HaidariAthensGreece124 62
    118Chennai Antiviral Research and Treatment Clinical Research Site (Site 612-402), VHS-IDMC, Voluntary Health Services, Rajiv Gandhi Salai, TaramaniChennaiTamil NaduIndia600113
    119Medical Centre, Voluntary Health Services (Site 612-402), Rajiv Gandhi Salai, TaramaniChennaiTamil NaduIndia600113
    120Hospital General Dr. Aurelio Valdivieso (Site 653-004), Calzada Porfirio Díaz No. 400Oaxaca de JuarezOaxacaMexico68050
    121Hospital General Dr. Manuel Gea González (Site 653-003), Av. Calzada de Tlalpan 4800, Colonia Belisario Domínguez Sec XVI Alcaldía TlalpanMexico CityMexico14080
    122Instituto 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 TlalpanMexico CityMexico14080
    123Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas" (Site 653-002), Calzada de Tlapan No. 4502, Col. Belisario Domínguez Sección XVI Alcaldía TlalpanMexico CityMexico14080
    124Centro 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 BMaputoMozambique
    125Institute of Human Virology Nigeria (IHVN) (Site 612-601), Plot 252, Herbert Macaulay Way, Central Business DistrictAbujaNigeria
    126Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37WarsawPoland01-201
    127Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock SengSingaporeSingapore308433
    128Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/nBadalonaBarcelonaSpain08916
    129Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80LleidaLeidaSpain25198
    130Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29BarcelonaSpain08003
    131Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129BarcelonaSpain08035
    132Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170BarcelonaSpain08036
    133Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/nBarcelonaSpain08907
    134Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46MadridSpain28017
    135Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CNMadridSpain28040
    136UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital MaternalMadridSpain28046
    137University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100ZürichZurichSwitzerland8091
    138MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral HospitalEntebbeUganda
    139Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160GuluUganda
    140Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago HillKampalaUganda
    141St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146KampalaUganda
    142Lira Regional Referral Hospital (Site 634-605)LiraUganda
    143Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556MasakaUganda
    144Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302), Department of Therapy #1, Hetmana Mazepy str. 114Ivano-Frankivs'kUkraine76018
    145Royal Victoria Infirmary (Site 634-007), Queen Victoria RoadNewcastle Upon TyneNorthumbriaUnited KingdomNE1 4LP
    146Royal Free Hospital (Site 634-006), Pond Street, HampsteadLondonUnited KingdomNW3 2QG
    147Guy's and St. Thomas' NHS Foundation Trust (Site 634-011)LondonUnited KingdomSE1 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)

    None provided.

    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:
    Mar 8, 2022
    Last Verified:
    Mar 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2022