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AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT05780437
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), AstraZeneca (Industry), University of Minnesota (Other)
1,455
Enrollment
124
Locations
2
Arms
25.8
Anticipated Duration (Months)
11.7
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 AZD7442 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H4.

Condition or Disease Intervention/Treatment Phase
  • Biological: AZD7442
  • Biological: Placebo
  • Biological: Remdesivir
 Phase 3

Detailed Description

This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of AZD7442 in hospitalized patients infected with COVID-19.

This is a randomized, blinded, controlled sub-study of AZD7442 plus current standard of care (SOC) against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. 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. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. 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.

If AZD7442 passes the 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.

This trial 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 :
1455 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 (Trial H4: AZD7442)
Actual Study Start Date :
Feb 5, 2021
Actual Primary Completion Date :
Jan 28, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: AZD7442 plus SOC

AZD7442 600 mg solution (separate vials containing 300 mg each of AZD88995 and AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion

Biological: AZD7442
AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2.
Other Names:
  • AZD8895 + AZD1061

    • Biological: Remdesivir
    Antiviral agent
    Other Names:
  • Veklury

    		•
    Placebo Comparator: Placebo plus SOC

    Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion

    Biological: Placebo
    Commercially available 0.9% sodium chloride solution

    Biological: Remdesivir
    Antiviral agent
    Other Names:
  • Veklury

    		•

    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 [Through Day 90]

    2. Composite of time to sustained recovery and mortality [Through 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 [Through Day 28]

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

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

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

    10. Incidence of infusion reactions [Through Day 0]

    11. Composite of SAEs or death [Through 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:
    • Refer to the master protocol (NCT04501978)
    Exclusion Criteria:

    • Refer to the master protocol (NCT04501978)

    • Additional Exclusion Criteria:

    • Pregnant women

    • Nursing mothers

    • 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 the entire 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 the entire 18 months of the study.

    • In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on AZD7442 and 150 on placebo, patients on highflow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this 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 VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive San Diego California United States 92161
    14 UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St. San Francisco California United States 94115
    15 San Francisco VAMC (Site 074-002), 4150 Clement St. San Francisco California United States 94121
    16 UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave. San Francisco California United States 94143
    17 Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr. Stanford California United States 94305
    18 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building Torrance California United States 90502
    19 University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue Aurora Colorado United States 80045
    20 Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic) Denver Colorado United States 80204
    21 National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street Denver Colorado United States 80206
    22 West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue West Haven Connecticut United States 06516
    23 MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW. Washington District of Columbia United States 20010
    24 Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW Washington District of Columbia United States 20422
    25 Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104 Bay Pines Florida United States 33744
    26 Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street Clearwater Florida United States 33756
    27 North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road Gainesville Florida United States 32608-1197
    28 Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street Hollywood Florida United States 33021
    29 Miami VAMC (Site 074-003), 1201 NW 16 Street Miami Florida United States 33125
    30 Hillsborough County Health Department, University of South Florida (Site 032-001) Tampa Florida United States 33602
    31 Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE Atlanta Georgia United States 30322
    32 Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard Fort Wayne Indiana United States 46804
    33 Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue Topeka Kansas United States 66604
    34 University of Kentucky Hospital (Site 210-004), 1000 South Limestone St. Lexington Kentucky United States 40536
    35 Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway New Orleans Louisiana United States 70121
    36 University of Maryland Medical Center (Site 301-019), 22 South Greene Street Baltimore Maryland United States 21201
    37 Massachusetts General Hospital (Site 202-002), 55 Fruit Street Boston Massachusetts United States 02114
    38 Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave. Boston Massachusetts United States 02215
    39 Baystate Medical Center (Site 201-001), 759 Chestnut Street Springfield Massachusetts United States 01199
    40 University of Michigan (Site 205-001), 1500 East Medical Center Drive Ann Arbor Michigan United States 48109
    41 Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd. Detroit Michigan United States 48202
    42 Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100 Minneapolis Minnesota United States 55407
    43 Hennepin Healthcare (Site 027-001), 701 Park Avenue Minneapolis Minnesota United States 55415
    44 Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70 Minneapolis Minnesota United States 55417
    45 M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE. Minneapolis Minnesota United States 55455
    46 University of Mississippi Medical Center (Site 202-005), 2500 North State Street Jackson Mississippi United States 39216
    47 Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive Lebanon New Hampshire United States 03756
    48 Cooper University Hospital (Site 019-001), One Cooper Plaza Camden New Jersey United States 08103
    49 Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street Bronx New York United States 10451
    50 Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road Bronx New York United States 10461
    51 Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street Bronx New York United States 10467
    52 SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave. Brooklyn New York United States 11203
    53 Maimonides Medical Center (Site 033-002), 4802 10th Avenue Brooklyn New York United States 11219
    54 Duke University Hospital (Site 301-006), 2301 Erwin Road Durham North Carolina United States 27710
    55 Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd Winston-Salem North Carolina United States 27157
    56 University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave. Cincinnati Ohio United States 45219
    57 University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue Cleveland Ohio United States 44106
    58 Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue Cleveland Ohio United States 44111
    59 Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue Cleveland Ohio United States 44195
    60 Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road Garfield Heights Ohio United States 44125
    61 Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd. Portland Oregon United States 97239-3098
    62 UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street Pittsburgh Pennsylvania United States 15213
    63 UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street Pittsburgh Pennsylvania United States 15213
    64 UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue Pittsburgh Pennsylvania United States 15232
    65 Rhode Island Hospital (Site 080-036), 593 Eddy Street Providence Rhode Island United States 02903
    66 The Miriam Hospital (Site 080-039), 164 Summit Ave. Providence Rhode Island United States 02906
    67 VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave. Providence Rhode Island United States 02908
    68 Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street Charleston South Carolina United States 29401
    69 MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214 Charleston South Carolina United States 29425
    70 MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway Florence South Carolina United States 29505
    71 VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South Nashville Tennessee United States 37212
    72 Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive Nashville Tennessee United States 37232
    73 Hendrick Medical Center (Site 080-014), 1900 Pine Street Abilene Texas United States 79601
    74 CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street Corpus Christi Texas United States 78404
    75 Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd Dallas Texas United States 75235
    76 UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor Dallas Texas United States 75235
    77 Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave. Dallas Texas United States 75246
    78 Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd. Houston Texas United States 77030
    79 Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266 Houston Texas United States 77030
    80 CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave. Longview Texas United States 75601
    81 Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street Murray Utah United States 84107
    82 University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207 Salt Lake City Utah United States 84108
    83 LDS Hospital (Site 211-004), 8th Ave. C Street Salt Lake City Utah United States 84143
    84 University of Virginia Health Systems (Site 301-021), 1215 Lee Street Charlottesville Virginia United States 22903
    85 Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue Roanoke Virginia United States 24014
    86 Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd. Salem Virginia United States 24153
    87 Swedish Hospital First Hill (Site 208-005), 747 Broadway Seattle Washington United States 98122
    88 West Virginia University (Site 301-023), One Medical Center Drive Morgantown West Virginia United States 26506
    89 Aalborg Hospital (Site 625-005), Hobrovej 18 Aalborg Denmark 9000
    90 Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99 Aarhus N Denmark 8200
    91 Righospitalet (Site 625-006), Blegdamsvej 9, Copenhagen Ø Denmark 2100
    92 Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23 Copenhagen Denmark 2400
    93 Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75 Herlev Denmark 2730
    94 Nordsjællands Hospital (Site 625-009), Dyrehavevej 29 Hillerød Denmark 3400
    95 Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30 Hvidovre Denmark 2650
    96 Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24 Kolding Denmark 6000
    97 Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4 Odense Denmark 5000
    98 Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10 Roskilde Denmark 4000
    99 Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana Alexandroupolis Evros Greece 68131
    100 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
    101 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
    102 3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave. Athens Greece 115 27
    103 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
    104 Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37 Warsaw Poland 01-201
    105 Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng Singapore Singapore 308433
    106 Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n Badalona Barcelona Spain 08916
    107 Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80 Lleida Leida Spain 25198
    108 Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29 Barcelona Spain 08003
    109 Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129 Barcelona Spain 08035
    110 Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170 Barcelona Spain 08036
    111 Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n Barcelona Spain 08907
    112 Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46 Madrid Spain 28017
    113 Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN Madrid Spain 28040
    114 UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal Madrid Spain 28046
    115 University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100 Zürich Zurich Switzerland 8091
    116 MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital Entebbe Uganda
    117 Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160 Gulu Uganda
    118 Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill Kampala Uganda
    119 St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146 Kampala Uganda
    120 Lira Regional Referral Hospital (Site 634-605) Lira Uganda
    121 Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556 Masaka Uganda
    122 Royal Victoria Infirmary (Site 634-007), Queen Victoria Road Newcastle Upon Tyne Northumbria United Kingdom NE1 4LP
    123 Royal Free Hospital (Site 634-006), Pond Street, Hampstead London United Kingdom NW3 2QG
    124 Guy's and St. Thomas' NHS Foundation Trust (Site 634-011) London United Kingdom SE1 7EH

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)
    • 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)
    • AstraZeneca
    • University of Minnesota

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT05780437
    Other Study ID Numbers:
    • 014/ACTIV-3/H4
    First Posted:
    Mar 22, 2023
    Last Update Posted:
    Mar 27, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    COVID-19
    COVID 19
    Coronaviridae Infections
    Coronavirus Infections
    RNA Virus Infections
    Virus Diseases
    Nidovirales Infections
    SARS-CoV-2
    SARS Coronavirus
    ACTIV-3
    ACTIV3
    TICO
    Additional relevant MeSH terms:
    COVID-19
    Remdesivir

    Study Results

    No Results Posted as of Mar 27, 2023